SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse

K250822 · Siemens Medical Solutions USA, Inc. · JAK · Jul 3, 2025 · Radiology

Device Facts

• Record ID: K250822
• Device Name: SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Jul 3, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of X-ray transmission data. The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment, and radiation therapy planning as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations*. * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Device Story

Computed tomography (CT) scanner system (single or dual source) utilizing fan beam principle; acquires X-ray transmission data via rotating tube-detector system; reconstructs cross-sectional images. Operated by trained staff (physicians, radiologists, technologists) in professional healthcare facilities. Features include mobile tablet workflow (Scan&GO), automated positioning (FAST 3D Camera), and various iterative reconstruction algorithms (ADMIRE, iMAR, SAFIRE). Output images (DICOM) used for diagnosis, treatment planning, and interventional guidance. System supports advanced post-processing via plugin interfaces. Benefits include optimized workflow, reduced radiation dose, and enhanced image quality for clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated via phantom tests, integration/functional testing, and retrospective blinded rater studies for specific features (e.g., HD FoV 5.0, ZeeFree RT). No clinical prospective/retrospective patient trials presented.

Technological Characteristics

Whole-body CT scanner; single or dual-source; Stellar detector (UFC); Athlon/Vectron X-ray tubes; tin filtration; iterative reconstruction (ADMIRE, iMAR, SAFIRE). Connectivity: DICOM, networked. Software: SOMARIS/10 syngo CT VB20. Standards: IEC 60601-2-44, IEC 61223-3-5, NEMA XR 25/28.

Indications for Use

Indicated for patients requiring cross-sectional imaging via CT reconstruction for diagnosis, treatment, radiation therapy planning, and diagnostic/therapeutic interventions. Includes low-dose lung cancer screening for high-risk populations as defined by professional medical societies.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• SOMATOM go. Platform CT Scanner Systems (K233650)
• SOMATOM Pro.Pulse (K232206)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 3, 2025

Siemens Medical Solutions USA, Inc.
% Kenny M Bello
Regulatory Affairs Professional
810 Innovation Drive
KNOXVILLE, TN 37932

Re: K250822
Trade/Device Name: SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed Tomography X-Ray System
Regulatory Class: Class II
Product Code: JAK
Dated: May 16, 2025
Received: June 16, 2025

Dear Kenny M Bello:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250822 | |
| Device Name SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse | |
| Indications for Use (Describe) This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of X-ray transmission data. The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment, and radiation therapy planning as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations*. * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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K250822

SIEMENS Healthineers

# 510(k) Summary

# SOMATOM go. Platform and SOMATOM Pro.Pulse with software version SOMARIS/10 syngo CT VB20

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

# I. Contact Details

## Submitter

Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville, TN 37932
Establishment Registration Number: 1034973

## Importer/Distributor

Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Establishment Registration Number: 2240869

## Location of Manufacturing Site (1)

Siemens Healthineers AG
Siemensstr. 1 -OR- Rittigfeld 1
D-91301 Forchheim, Germany
Establishment Registration Number: 3004977335

## Location of Manufacturing Site (2)

SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD
278 Zhou Zhu Rd
Shanghai, CHINA, 201318
Establishment Registration Number: 3003202425

Note: Descriptions in this submission use the short company name Siemens. It covers both manufacturing locations and names as listed above. Brand name on all products is Siemens Healthineers.

Siemens Healthineers AG

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K250822

SIEMENS Healthineers

Submitter Contact Person:
Kenny M Bello
Regulatory Affairs Professional
Siemens Medical Solutions USA, Inc.
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932
Phone: [phone]
[e-mail]

# II. Device Name and Classification

Table 1: Subject Device Names

| Product Name | Trade Name |
| --- | --- |
| SOMATOM go.Now | SOMATOM go.Now |
| SOMATOM go.Up | SOMATOM go.Up |
| SOMATOM go.All | SOMATOM go.All |
| SOMATOM go.Top | SOMATOM go.Top |
| SOMATOM go.Sim | SOMATOM go.Sim |
| SOMATOM go.Open Pro | SOMATOM go.Open Pro |
| SOMATOM Pro.Pulse | SOMATOM Pro.Pulse |

Classification Name: Computed Tomography X-ray System
Classification Panel: Radiology
Regulation Number: 21 CFR §892.1750
Device Class: Class II
Product Code: JAK

# III. Predicate Device

Primary predicate device:

Trade Name: SOMATOM go. Platform CT Scanner Systems with SOMARIS/10 syngo CT VB10 software
510(k) Number: K233650
Clearance Date: March 26, 2024
Classification Name: Computed Tomography X-ray System
Classification Panel: Radiology
Regulation Number: 21 CFR §892.1750
Device Class: Class II
Product Code: JAK
Recall Information: All predicate device recalls have been considered in the subject device design.

Siemens Healthineers AG

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K250822

SIEMENS Healthineers

# Secondary predicate device:

Trade Name: SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 software
510(k) Number: K232206
Clearance Date: December 6, 2024
Classification Name: Computed Tomography X-ray System
Classification Panel: Radiology
Regulation Number: 21 CFR §892.1750
Device Class: Class II
Product Code: JAK
Recall Information: All predicate device recalls have been considered in the subject device design.

# Note:

K233650 was a bundle submission with various Siemens CT Scanner Systems, including the CT scanner systems SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite, SOMATOM X.ceed.

# IV. Device Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB20 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

# a) Single Source CT Scanner systems (SOMATOM go. Platform):

- SOMATOM go.Now
- SOMATOM go.Up
- SOMATOM go.All
- SOMATOM go.Top
- SOMATOM go.Sim
- SOMATOM go.Open Pro

In this submission, the above listed CT scanner systems are jointly referred to as subject devices by "SOMATOM go. Platform" CT scanner systems.

# b) Dual Source CT Scanner system:

- SOMATOM Pro.Pulse

The above listed subject devices with SOMARIS/10 syngo CT VB20 are Computed Tomography X-ray Systems which feature one (Single Source) or two (Dual Source) continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go. Platform and the SOMATOM Pro.Pulse with software SOMARIS/10 syngo CT VB20 produce CT images in DICOM format, which can be used by trained staff for software applications, e.g. post-processing applications, commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.

Siemens Healthineers AG

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K250822

SIEMENS Healthineers

Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.

The software platform provides plugin software interfaces that allow for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.

New software version syngo CT VB20 (SOMARIS/10 syngo CT VB20) is a modified software version based on syngo CT VB10 (SOMARIS/10 syngo CT VB10) which was cleared for the predicate devices in K233650 (SOMATOM go. Platform) and in K232206 (SOMATOM Pro.Pulse).

Software version SOMARIS/10 syngo CT VB20 will be offered ex-factory and as an optional upgrade for the applicable existing SOMATOM go. Platform and SOMATOM Pro.Pulse CT Scanner Systems.

The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. The supporting data are similar, primarily one review division/group will be involved, and the indications for use is the same between the devices. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.

# V. Indications for Use

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment, and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

# VI. Indications for Use Comparison

Subject Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

Siemens Healthineers AG

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K250822

SIEMENS Healthineers

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

## Primary Predicate Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

## Secondary Predicate Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

## Comparison:

The subject device Indications for Use is the exact same as the primary (K233650) and the secondary (K232206) predicate's Indications for Use. As such, the Indications for Use remains unchanged from the predicate devices and is substantially equivalent to the predicate devices.

## VII. Comparison of Technological Characteristics with the Predicate Device

Supported by the subject device, SOMARIS/10 syngo CT VB20 software version is a further development of the SOMARIS/10 syngo CT VB10 software version which is cleared in K233650 and K232206.

The SOMATOM go. Platform and SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20 software version provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software features of the SOMATOM go. Platform and SOMATOM Pro.Pulse have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices.

Siemens Healthineers AG

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K250822

SIEMENS Healthineers

The new syngo CT VB20 software reuses all unmodified software features of the legacy software syngo CT VB10 cleared in K233650 and K232206. Additionally, no features present in the predicate device are descoped.

Software version SOMARIS/10 syngo CT VB20 is designed to reuse hardware independent extended functionalities and GO technologies provided by Siemens cleared software applications.

The intended use and fundamental scientific technology for the SOMATOM go. Platform and SOMATOM Pro.Pulse remain unchanged from the predicate devices.

At a high level, the subject and predicate devices are based on the same subset of technological elements:

- Scanner Principle – Whole body X-Ray Computed Tomography Scanner
- System Acquisition – Continuously rotating tube detector system
- Iterative Reconstruction – Support of various iterative reconstruction principles
- Workplaces – Support of workplaces that include reconstruction and image evaluation software
- Patient table
- Patient table foot switch for movement
- Stellar Detector technology
- Tin filtration technology
- Athlon/Vectron X-ray Tube
- Power Generator
- Scan&GO
- Mobile workflow (Tablet)
- Optional injector arm
- Optional support of CT guided intervention workflow (myNeedle Companion – myNeedle Guide)
- Optional support of FAST 3D Camera for patient positioning workflow
- Scanner display and control functionality
- Remote Scan Control
- Interfaces for Respiratory Gating Devices
- Standard CARE technologies
- Standard FAST technologies
- Standard GO technologies
- Precision matrix (large image matrices)
- HD FoV
- DirectDensity
- Stack artefact reduced reconstruction

The terms in the following Table 2 are used to indicate various technological characteristics in comparison to the primary and secondary predicate devices information:

Table 2: Overview of term definition.

| Term | Definition |
| --- | --- |
| new | The feature is newly supported for Siemens CT Scanners and newly introduced within the subject device submission |

Siemens Healthineers AG

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K250822

SIEMENS Healthineers

| Term | Definition |
| --- | --- |
| modified | This feature is modified from the predicate devices |
| enabled | This feature is currently supported by other cleared Siemens CT systems or cleared Siemens stand-alone software applications. This feature will be supported for the subject device with software version SOMARIS/10 syngo CT VB20 and is substantially equivalent compared to the cleared version of the predicate devices. |
| unmodified | The feature remains unchanged from the predicate device. |
| n.a. | The feature is not supported for the subject/predicate device |

The subject devices SOMATOM go. Platform and SOMATOM Pro.Pulse CT scanner systems with SOMARIS/10 syngo CT VB20 will support hardware and software modifications/further developments in comparison to the predicate devices as listed in Table 3. The column "HW/ SW change" in the table contains reference to a hardware (HW) or/and software (SW) change. The columns under "Predicate devices" of the Table 3 indicate the clearance of the technological properties in the corresponding predicate device.

Siemens Healthineers AG

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Table 3: Summary of modifications (hardware and software) of the subject devices SOMATOM go. Platform and SOMATOM Pro.Pulse with software version SOMARIS/10 syngo CT VB20 compared to the predicate devices.

| | Technological property | HW/SW change | Subject devices | | Predicate devices | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | Single Source | Dual Source | Single Source | Dual Source |
| | | | SOMATOM go. Platform with syngo CT VB20 | SOMATOM Pro.Pulse with syngo CT VB20 | SOMATOM go. Platform with syngo CT VB10 (K233650) | SOMATOM Pro.Pulse with syngo CT VB10 (K232206) |
| 1. | CARE Moodlight | HW/SW | enabled^{1} (same as in K233650) | unmodified | cleared | cleared |
| 2. | Interfaces for respiratory gating | HW | modified^{2} (same as in K233650, with exception of Open Online Interface which are introduced with syngo CT VB20) | n.a. | cleared | n.a. |
| 3. | Eco Power Mode | HW/SW | new^{3} | new | n.a. | n.a. |

1. In software version syngo CT VB20, the functionality CARE Moodlight is enabled for the subject devices SOMATOM go.Sim and SOMATOM go.Open Pro. For the subject devices SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, and SOMATOM go.Top, the functionality CARE Moodlight was cleared in K233650 and it remains unchanged in software version syngo CT VB20.
2. SOMATOM go.Now does not support respiratory gating interfaces.
3. SOMATOM go.Now and SOMATOM go.Up do not support Eco Power Mode.

Siemens Healthineers AG

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SIEMENS Healthineers

| | Technological property | HW/SW change | Subject devices | | Predicate devices | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | Single Source | Dual Source | Single Source | Dual Source |
| | | | SOMATOM go. Platform with syngo CT VB20 | SOMATOM Pro.Pulse with syngo CT VB20 | SOMATOM go. Platform with syngo CT VB10 (K233650) | SOMATOM Pro.Pulse with syngo CT VB10 (K232206) |
| 4. | FAST 3D Camera/ FAST Integrated Workflow | SW | modified
(same as in K233650, with exception of retrained FAST 3D Camera algorithms, collision indication, and Centerline/Grid Overlay which are introduced with syngo CT VB20) | modified
(same as in K232206, with exception of retrained FAST 3D Camera algorithms, collision indication, and Centerline/Grid Overlay which are introduced with syngo CT VB20) | cleared | cleared |
| 5. | Oncology Exchange | SW | new | new | n.a. | n.a. |
| 6. | DirectSetup Notes | SW | enabled^{4}
(same as in K233650) | enabled^{4}
(same as in K233650) | cleared | n.a. |
| 7. | FAST Planning | SW | modified
(same as in K233650, with exception of the detection | modified
(same as in K232206, with exception of the detection | cleared | cleared |

Siemens Healthineers AG

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| | Technological property | HW/SW change | Subject devices | | Predicate devices | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | Single Source | Dual Source | Single Source | Dual Source |
| | | | SOMATOM go. Platform with syngo CT VB20 | SOMATOM Pro.Pulse with syngo CT VB20 | SOMATOM go. Platform with syngo CT VB10 (K233650) | SOMATOM Pro.Pulse with syngo CT VB10 (K232206) |
| | | | of additional body regions which are introduced with syngo CT VB20) | of additional body regions which are introduced with syngo CT VB20) | | |
| 8. | myExam Companion – myExam Compass/myExam Cockpit | SW | modified (same as in K233650, with exception of the clinical decision trees now also available for child protocols) | modified (same as in K233650, with exception of the clinical decision trees now also available for child protocols) | cleared | cleared |
| 9. | HD FoV 5.0 | SW | new^{5} | n.a. | n.a. | n.a. |
| 10. | CT guided intervention – myAblation Guide interface | SW | new | new | n.a. | n.a. |
| 11. | Flex 4D Spiral | SW | modified^{6} | modified | cleared^{6} | cleared |

Siemens Healthineers AG

5 In software version syngo CT VB20, the functionality HD FoV 5.0 is introduced only for the subject devices SOMATOM go.Sim and SOMATOM go.Open Pro.
6 The CT scanner CT systems SOMATOM go.Now and SOMATOM go.Up do not support Flex 4D Spiral.

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| | Technological property | HW/SW change | Subject devices | | Predicate devices | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | Single Source | Dual Source | Single Source | Dual Source |
| | | | SOMATOM go. Platform with syngo CT VB20 | SOMATOM Pro.Pulse with syngo CT VB20 | SOMATOM go. Platform with syngo CT VB10 (K233650) | SOMATOM Pro.Pulse with syngo CT VB10 (K232206) |
| | | | (same as in K233650, with exception of the modifications regarding dynamic tube current modulation which is introduced with syngo CT VB20) | (same as in K233650, with exception of the modifications regarding dynamic tube current modulation which is introduced with syngo CT VB20) | | |
| 12. | ZeeFree RT | SW | new^{7} | n.a. | n.a. | n.a. |
| 13. | DirectDensity | SW | modified
(same as in K233650, with exception of the calculation of stopping-power ratio (Kernel St) which is introduced with syngo CT VB20) | modified
(same as in K233650, with exception of the calculation of stopping-power ratio (Kernel St) which is introduced with syngo CT VB20) | cleared | cleared |
| 14. | DirectLaser | HW/SW | modified^{8} | n.a. | cleared^{8} | n.a. |

Siemens Healthineers AG

7 In software version syngo CT VB20, the functionality ZeeFree RT is introduced only for the subject device SOMATOM go.Open Pro.
8 DirectLaser is available only for SOMATOM go.Sim and SOMATOM go.Open Pro.

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| | Technological property | HW/SW change | Subject devices | | Predicate devices | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | Single Source | Dual Source | Single Source | Dual Source |
| | | | SOMATOM go. Platform with syngo CT VB20 | SOMATOM Pro.Pulse with syngo CT VB20 | SOMATOM go. Platform with syngo CT VB10 (K233650) | SOMATOM Pro.Pulse with syngo CT VB10 (K232206) |
| | | | (same as in K233650, with exception of the Patient Marking workflow improvement introduced with syngo CT VB20) | | | |
| 15. | myExam Contrast | SW | new | new | n.a. | n.a. |

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A tabular summary of the comparable hardware and software properties between the subject devices SOMATOM go. Platform and SOMATOM Pro.Pulse with software version syngo CT VB20 and the predicate devices are listed in Table 4 through Table 8 below (modifications are in gray shaded sections).

Table 4 provides comparison of the hardware properties between the single source subject devices SOMATOM go.Now and SOMATOM go.Up with software version syngo CT VB20 and the predicate devices SOMATOM go.Now and SOMATOM go.Up with software version syngo CT VB10 (K233650).

Table 5 provides comparison of the hardware properties between the single source subject devices SOMATOM go.All and SOMATOM go.Top with software version syngo CT VB20 and the predicate devices SOMATOM go.All and SOMATOM go.Top with software version syngo CT VB10 (K233650).

Table 6 provides comparison of the hardware properties between the single source subject devices SOMATOM go.Sim and SOMATOM go.Open Pro with software version syngo CT VB20 and the predicate devices SOMATOM go.Sim and SOMATOM go.Open.Pro with software version syngo CT VB10 (K233650).

Table 7 provides comparison of the hardware properties between the dual source subject device SOMATOM Pro.Pulse with software version syngo CT VB20 and the predicate devices SOMATOM Pro.Pulse (K233650) and SOMATOM go.Top with software version syngo CT VB10 (233650).

Table 8 compares the software technological characteristics of the subject devices and the predicate devices.

Table 4: Comparison of technical hardware characteristics between the subject devices SOMATOM go.Now and SOMATOM go.Up with software version syngo CT VB20 and the primary predicate devices SOMATOM go.Now and SOMATOM go.Up with software version syngo CT VB10 (K233650).

| Hardware property | Subject device SOMATOM go. Platform with SOMARIS/10 syngo CT VB20 | | Primary predicate device SOMATOM go. Platform with SOMARIS/10 syngo CT VB10 (K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now | SOMATOM go.Up | SOMATOM go.Now | SOMATOM go.Up | |
| scanner | Whole body Computed Tomography (CT) Scanner System | | Whole body Computed Tomography (CT) Scanner System | | Same as the primary predicate devices |
| System Configuration | Single Source | | Single Source | | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now | SOMATOM go.Up | SOMATOM go.Now | SOMATOM go.Up | |
| Environment of Use | Professional Healthcare Facility | | Professional Healthcare Facility | | Same as the primary predicate devices |
| Generator
Max. power (kW) | 32 | | 32 | | Same as the primary predicate devices |
| Detector
technology | Stellar
based on UFC (Ultra Fast Ceramic) | | Stellar
based on UFC (Ultra Fast Ceramic) | | Same as the primary predicate devices |
| Detector
volume coverage (mm) | 11.2 | 22.4 | 11.2 | 22.4 | Same as the primary predicate devices |
| Detector
physical rows | 16 | 32 | 16 | 32 | Same as the primary predicate devices |
| Detector
Slice width (mm) | 0.7 | | 0.7 | | Same as the primary predicate devices |
| Detector
DAS channel no. | 768 | | 768 | | Same as the primary predicate devices |
| Detector
Image slices | 32 | 64 | 32 | 64 | Same as the primary predicate devices |
| Tube
technology | Chronon | | Chronon | | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now | SOMATOM go.Up | SOMATOM go.Now | SOMATOM go.Up | |
| Tube
kV steps | 80, 110, 130 | | 80, 110, 130 | | Same as the primary predicate devices |
| Tube
Max. current (mA) | 400 | | 400 | | Same as the primary predicate devices |
| Tube
focus | • 0.8 x 0.4 / 8°
• 0.8 x 0.7 / 8° | | • 0.8 x 0.4 / 8°
• 0.8 x 0.7 / 8° | | Same as the primary predicate devices |
| Tube
Heat storage capacity
(MHU) | 3.5 | | 3.5 | | Same as the primary predicate devices |
| Tube
Cooling rate (kHU/ min) | 915 | | 915 | | Same as the primary predicate devices |
| Gantry
Bore size | 70 | | 70 | | Same as the primary predicate devices |
| Gantry
Scan FoV (cm) | 50 | | 50 | | Same as the primary predicate devices |
| Gantry
Extended FoV (cm) | 70 | | 70 | | Same as the primary predicate devices |
| Gantry
Rot. time (sec) | 0.5, 0.8, 1.0, 1.5 | | 0.5, 0.8, 1.0, 1.5 | | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now | SOMATOM go.Up | SOMATOM go.Now | SOMATOM go.Up | |
| Gantry
Tilt (degree) | n.a. | +/- 30°
-30° to +28° with optional 307 kg patient table | n.a. | +/- 30°
-30° to +28° with optional 307 kg patient table | Same as the primary predicate devices |
| Patient table
Type | Vector (1250 mm),
Vario 1 (1600 mm),
Vario RT (1600 mm)
with table extension | Vario 1 (1600 mm),
Vario 2 (2000 mm),
Vario RT (1600 mm)
with table extension | Vector (1250 mm),
Vario 1 (1600 mm),
Vario RT (1600 mm)
with table extension | Vario 1 (1600 mm),
Vario 2 (2000 mm),
Vario RT (1600 mm)
with table extension | Same as the primary predicate devices |
| Patient table
Max. weight capacity
(kg) | Vector: 160
Vario 1: 227
Vario RT: 227 | Vario 1: 227
Vario 2: 307
Vario RT: 227 | Vector: 160
Vario 1: 227
Vario RT: 227 | Vario 1: 227
Vario 2: 307
Vario RT: 227 | Same as the primary predicate devices |
| Max. scan length
topogram | 1680 mm with table extension | 1680 mm with table extension
2080 mm with table extension | 1680 mm with table extension | 1680 mm with table extension
2080 mm with table extension | Same as the primary predicate devices |
| Max. scan length
Image acquisition | Max. 1600 mm with patient table extension | Max. 1600 mm with patient table extension | Max. 1600 mm with patient table extension | Max. 1600 mm with patient table extension | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now | SOMATOM go.Up | SOMATOM go.Now | SOMATOM go.Up | |
| | | Max. 2000 mm with patient table extension | | Max. 2000 mm with patient table extension | |
| Spectral filtration | Tin Filter | | Tin Filter | | Same as the primary predicate devices |
| High Power 80 | yes | yes | yes | yes | Same as the primary predicate devices |
| FAST 3D Camera | option for patient positioning with 3D Camera:
• gantry mounted | option for patient positioning with 3D Camera:
• ceiling mounted
• gantry mounted | option for patient positioning with 3D Camera:
• gantry mounted | option for patient positioning with 3D Camera:
• ceiling mounted
• gantry mounted | Same as the primary predicate devices |
| x-ray foot switch | Option to trigger hands-free scanning | | Option to trigger hands-free scanning | | Same as the primary predicate devices |
| Table foot switch | Option for table patient movement | | Option for table patient movement | | Same as the primary predicate devices |
| i-joystick | Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted. | | Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted. | | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now | SOMATOM go.Up | SOMATOM go.Now | SOMATOM go.Up | |
| Tablet dock | Option for mounting of the tablet on the patient table. | | Option for mounting of the tablet on the patient table. | | Same as the primary predicate devices |
| CARE Breathe | visualization of breathing instructions to support three messages in respiratory motion management:
• free breathing
• preparation for breath hold
• breath hold itself in combination with the visualization of a countdown

visual patient instruction unit is placed on the gantry front and gantry back in the gantry funnel | | visualization of breathing instructions to support three messages in respiratory motion management:
• free breathing
• preparation for breath hold
• breath hold itself in combination with the visualization of a countdown

visual patient instruction unit is placed on the gantry front and gantry back in the gantry funnel | | Same as the primary predicate devices |
| CARE 2D camera | one integrated into the gantry front and one mounted on the gantry back to monitor the patient during examination | | one integrated into the gantry front and one mounted on the gantry back to monitor the patient during examination | | Same as the primary predicate devices |
| CARE Moodlight | LED lights integrated on the gantry front cover indicating:
• System startup
• Scan countdown
• Scan | | LED lights integrated on the gantry front cover indicating:
• System startup
• Scan countdown
• Radiation on | | Same functionality as the primary predicate devices.
In the subject devices with syngo CT VB20, the status “Radiation on” has been renamed to “Scan”. |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now | SOMATOM go.Up | SOMATOM go.Now | SOMATOM go.Up | |
| Respiratory Motion management - Interfaces for respiratory gating | n.a. | acquisition of respiration-correlated scans supported
Interface connectors for:
• Anzai respiratory gating system
Varian RGSC respiratory gating system
• Open interface compatible respiratory gating systems
• Open Online interface | n.a. | acquisition of respiration-correlated scans supported
Interface connectors for:
• Anzai respiratory gating system
Varian RGSC respiratory gating system
• Open interface compatible respiratory gating systems | Same as the primary predicate device, the subject device SOMATOM go.Up with software version syngo CT VB20 support acquisition of respiration-correlated scans. For measurement of the breathing signal of the patient, interfaces for connecting of 3^{rd} party respiratory gating devices are offered.
Introduction of new Open Online Interface. |

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Table 5: Comparison of technical hardware characteristics between the subject devices SOMATOM go.All and SOMATOM go.Top with software version syngo CT VB20 and the primary predicate devices SOMATOM go.All and SOMATOM go.Top with software version syngo CT VB10 (K233650).

| Hardware property | Subject device SOMATOM go. Platform with SOMARIS/10 syngo CT VB20 | | Primary predicate device SOMATOM go. Platform with SOMARIS/10 syngo CT VB10 (K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.All | SOMATOM go.Top | SOMATOM go.All | SOMATOM go.Top | |
| scanner | Whole body Computed Tomography (CT) Scanner System | | Whole body Computed Tomography (CT) Scanner System | | Same as the primary predicate devices |
| System Configuration | Single Source | | Single Source | | Same as the primary predicate devices |
| Environment of Use | Professional Healthcare Facility | | Professional Healthcare Facility | | Same as the primary predicate devices |
| Generator Max. power (kW) | 75 | | 75 | | Same as the primary predicate devices |
| Detector technology | Stellar based on UFC (Ultra Fast Ceramic) | | Stellar based on UFC (Ultra Fast Ceramic) | | Same as the primary predicate devices |
| Detector volume coverage (mm) | 22.4 | 38.4 | 22.4 | 38.4 | Same as the primary predicate devices |
| Detector physical rows | 32 | 64 | 32 | 64 | Same as the primary predicate devices |
| Detector Slice width (mm) | 0.7 | 0.6 | 0.7 | 0.6 | Same as the primary predicate devices |
| Detector DAS channel no. | 768 | 840 | 768 | 840 | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.All | SOMATOM go.Top | SOMATOM go.All | SOMATOM go.Top | |
| Detector
Image slices | 64 | 128 | 64 | 128 | Same as the primary predicate devices |
| Tube
technology | Athlon | | Athlon | | Same as the primary predicate devices |
| Tube
kV steps | 70 to 140 (in 10 kV steps) | | 70 to 140 (in 10 kV steps) | | Same as the primary predicate devices |
| Tube
Max. current (mA) | 825 | | 825 | | Same as the primary predicate devices |
| Tube
focus | • 1.1 x 1.2 / 8"
• 0.8 x 0.8 / 8" | | • 1.1 x 1.2 / 8"
• 0.8 x 0.8 / 8" | | Same as the primary predicate devices |
| Tube
Heat storage capacity
(MHU) | 7 | | 7 | | Same as the primary predicate devices |
| Tube
Cooling rate (kHU/ min) | Up to 1700 | | Up to 1700 | | Same as the primary predicate devices |
| Gantry
Bore size | 70 | | 70 | | Same as the primary predicate devices |
| Gantry
Scan FoV (cm) | 50 | | 50 | | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.All | SOMATOM go.Top | SOMATOM go.All | SOMATOM go.Top | |
| Gantry
Extended FoV (cm) | 70 | | 70 | | Same as the primary predicate devices |
| Gantry
Rot. time (sec) | 0.33, 0.5, 1.0 | | 0.33, 0.5, 1.0 | | Same as the primary predicate devices |
| Gantry
Tilt (degree) | +/- 30°
-30° to +28° with optional 307 kg patient table | | +/- 30°
-30° to +28° with optional 307 kg patient table | | Same as the primary predicate devices |
| Patient table
Type | Vario 1 (1600 mm)
Vario 2 (2000 mm)
Vario RT (1600 mm)
with table extension | | Vario 1 (1600 mm)
Vario 2 (2000 mm)
Vario RT (1600 mm)
with table extension | | Same as the primary predicate devices |
| Patient table
Max. weight capacity
(kg) | Vario 1: 227
Vario 2: 307
Vario RT: 227 | | Vario 1: 227
Vario 2: 307
Vario RT: 227 | | Same as the primary predicate devices |
| Max. scan length
topogram | 1680 mm with table extension
2080 mm with table extension | | 1680 mm with table extension
2080 mm with table extension | | Same as the primary predicate devices |
| Max. scan length
Image acquisition | Max. 1600 mm with patient table extension
Max. 2000 mm with patient table extension | | Max. 1600 mm with patient table extension
Max. 2000 mm with patient table extension | | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.All | SOMATOM go.Top | SOMATOM go.All | SOMATOM go.Top | |
| Spectral filtration | Tin Filter | Combined Tin Filter/Split filter | Tin Filter | Combined Tin Filter/Split filter | Same as the primary predicate devices |
| High Power 70/ High Power 80 | 825 (@70 kV) | | 825 (@70 kV) | | Same as the primary predicate devices |
| | 825 (@ 80 kV) | | 825 (@ 80 kV) | | |
| FAST 3D Camera | option for patient positioning with FAST 3D Camera:
• ceiling mounted
• gantry mounted | | option for patient positioning with FAST 3D Camera:
• ceiling mounted
• gantry mounted | | Same as the primary predicate devices |
| x-ray foot switch | Option to trigger hands-free scanning | | Option to trigger hands-free scanning | | Same as the primary predicate devices |
| Table foot switch | Option for table patient movement | | Option for table patient movement | | Same as the primary predicate devices |
| i-joystick | Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted. | | Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted. | | Same as the primary predicate devices |
| Tablet dock | Option for mounting of the tablet on the patient table. | | Option for mounting of the tablet on the patient table. | | Same as the primary predicate devices |
| CARE Breathe | visualization of breathing instructions to support three messages in respiratory motion management: | | visualization of breathing instructions to support three messages in respiratory motion management: | | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.All | SOMATOM go.Top | SOMATOM go.All | SOMATOM go.Top | |
| | • free breathing
• preparation for breath hold
• breath hold itself in combination with the visualization of a countdown
visual patient instruction unit is placed on the gantry front and gantry back in the gantry funnel | | • free breathing
• preparation for breath hold
• breath hold itself in combination with the visualization of a countdown
visual patient instruction unit is placed on the gantry front and gantry back in the gantry funnel | | |
| CARE 2D camera | one integrated into the gantry front and one mounted on the gantry back to monitor the patient during examination | | one integrated into the gantry front and one mounted on the gantry back to monitor the patient during examination | | Same as the primary predicate devices |
| CARE Moodlight | LED lights integrated on the gantry front cover indicating:
• System startup
• Scan countdown
• Scan | | LED lights integrated on the gantry front cover indicating:
• System startup
• Scan countdown
• Radiation on | | Same functionality as the primary predicate devices
In the subject devices with syngo CT VB20, the status “Radiation on” has been renamed to “Scan”. |
| Respiratory Motion management - Interfaces for respiratory gating | acquisition of respiration-correlated scans supported
Interface connectors for:
• Anzai respiratory gating system
• Varian RGSC respiratory gating system | | acquisition of respiration-correlated scans supported
Interface connectors for:
• Anzai respiratory gating system
• Varian RGSC respiratory gating system | | Same as the primary predicate devices, the subject devices SOMATOM go.All and SOMATOM go.Top with software version syngo CT VB20 support acquisition of respiration-correlated scans. |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.All | SOMATOM go.Top | SOMATOM go.All | SOMATOM go.Top | |
| | • Open interface compatible respiratory gating systems
• Open Online interface | | • Open interface compatible respiratory gating systems | | For measurement of the breathing signal of the patient, interfaces for connecting of 3^{rd} party respiratory gating devices are offered.
Introduction of new Open Online Interface. |

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Table 6: Comparison of technical hardware characteristics between the subject devices SOMATOM go.Sim and SOMATOM go.Open Pro with software version syngo CT VB20 and the primary predicate devices SOMATOM go.Sim and SOMATOM go.Open Pro with software version syngo CT VB10 (K233650).

| Hardware property | Subject device SOMATOM go. Platform with SOMARIS/10 syngo CT VB20 | | Primary predicate device SOMATOM go. Platform with SOMARIS/10 syngo CT VB10 (K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Sim | SOMATOM go.Open Pro | SOMATOM go.Sim | SOMATOM go.Open Pro | |
| scanner | Whole body Computed Tomography (CT) Scanner System | | Whole body Computed Tomography (CT) Scanner System | | Same as the primary predicate devices |
| System Configuration | Single Source | | Single Source | | Same as the primary predicate devices |
| Environment of Use | Professional Healthcare Facility | | Professional Healthcare Facility | | Same as the primary predicate devices |
| Generator Max. power (kW) | 75 | | 75 | | Same as the primary predicate devices |
| Detector technology | Stellar based on UFC (Ultra Fast Ceramic) | | Stellar based on UFC (Ultra Fast Ceramic) | | Same as the primary predicate devices |
| Detector volume coverage (mm) | 19.2 | 38.4 | 19.2 | 38.4 | Same as the primary predicate devices |
| Detector physical rows | 32 | 64 | 32 | 64 | Same as the primary predicate devices |
| Detector Slice width (mm) | 0.6 | 0.6 | 0.6 | 0.6 | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Sim | SOMATOM go.Open Pro | SOMATOM go.Sim | SOMATOM go.Open Pro | |
| Detector
DAS channel no. | 920 | 920 | 920 | 920 | Same as the primary predicate devices |
| Detector
Image slices | 64 | 128 | 64 | 128 | Same as the primary predicate devices |
| Tube
technology | Athlon | | Athlon | | Same as the primary predicate devices |
| Tube
kV steps | 70 to 140 (in 10 kV steps) | | 70 to 140 (in 10 kV steps) | | Same as the primary predicate devices |
| Tube
Max. current (mA) | 825 | | 825 | | Same as the primary predicate devices |
| Tube
focus | • 1.1 x 1.2 / 7"
• 0.8 x 0.8 / 7" | | • 1.1 x 1.2 / 7"
• 0.8 x 0.8 / 7" | | Same as the primary predicate devices |
| Tube
Heat storage capacity
(MHU) | 7 | | 7 | | Same as the primary predicate devices |
| Tube
Cooling rate (kHU/ min) | Up to 1700 | | Up to 1700 | | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Sim | SOMATOM go.Open Pro | SOMATOM go.Sim | SOMATOM go.Open Pro | |
| Gantry
Bore size | 85 | | 85 | | Same as the primary predicate devices |
| Gantry
Scan FoV (cm) | 60 | | 60 | | Same as the primary predicate devices |
| Gantry
Extended FoV (cm) | 85 | | 85 | | Same as the primary predicate devices |
| Gantry
Rot. time (sec) | 0.35, 0.5, 1.0 | | 0.35, 0.5, 1.0 | | Same as the primary predicate devices |
| Gantry
Tilt (degree) | -30° to +25° | | -30° to +25° | | Same as the primary predicate devices |
| Patient table
Type | Vario 2 (2000 mm)
Vario RT (1600 mm)
with table extension | | Vario 2 (2000 mm)
Vario RT (1600 mm)
with table extension | | Same as the primary predicate devices |
| Patient table
Max. weight capacity
(kg) | Vario 2: 307
Vario RT: 227 | | Vario 2: 307
Vario RT: 227 | | Same as the primary predicate devices |
| Max. scan length
topogram | 1680 mm with table extension
2080 mm with table extension | | 1680 mm with table extension
2080 mm with table extension | | Same as the primary predicate devices |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Sim | SOMATOM go.Open Pro | SOMATOM go.Sim | SOMATOM go.Open Pro | |
| Max. scan length
Image acquisition | Max. 1600 mm with patient table extension
Max. 2000 mm with patient table extension | | Max. 1600 mm with patient table extension
Max. 2000 mm with patient table extension | | Same as the primary predicate devices |
| Spectral filtration | Tin Filter | Combined Tin Filter/Split filter | Tin Filter | Combined Tin Filter/Split filter | Same as the primary predicate devices |
| High Power 70/ High Power 80 | 825 (@70 kV)
825 (@ 80 kV) | | 825 (@70 kV)
825 (@ 80 kV) | | Same as the primary predicate devices |
| FAST 3D Camera | option for patient positioning with FAST 3D Camera:
• ceiling mounted | | option for patient positioning with FAST 3D Camera:
• ceiling mounted | | Same as the primary predicate devices |
| CARE Moodlight | LED lights integrated on the gantry front cover indicating:
• System startup
• Scan countdown
• Scan | | LED lights integrated on the gantry front cover indicating^{9}:
• System startup
• Scan countdown
• Radiation on | | CARE Moodlight is introduced for SOMATOM go.Sim and SOMATOM go.Open Pro
In the subject devices with syngo CT VB20, the status |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Sim | SOMATOM go.Open Pro | SOMATOM go.Sim | SOMATOM go.Open Pro | |
| | | | | | "Radiation on" has been renamed to "Scan". |
| x-ray foot switch | Option to trigger hands-free scanning | | Option to trigger hands-free scanning | | Same as the primary predicate devices |
| Table foot switch | Option for table patient movement | | Option for table patient movement | | Same as the primary predicate devices |
| i-joystick | Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted. | | Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted. | | Same as the primary predicate devices |
| Tablet dock | Option for mounting of the tablet on the patient table. | | Option for mounting of the tablet on the patient table. | | Same as the primary predicate devices |
| CARE Breathe | n.a. | | n.a. | | Same as the primary predicate devices |
| CARE 2D camera | Patient observation camera integrated on gantry front | | Patient observation camera integrated on gantry front | | Same as the primary predicate devices |
| Respiratory Motion management - Interfaces for respiratory gating | acquisition of respiration-correlated scans supported
Interface connectors for: | | acquisition of respiration-correlated scans supported
Interface connectors for: | | Same as the primary predicate devices, the subject devices SOMATOM go.Sim and SOMATOM go.Open Pro with software version syngo CT |

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| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB20 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10
(K233650) | | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Sim | SOMATOM go.Open Pro | SOMATOM go.Sim | SOMATOM go.Open Pro | |
| | • Anzai respiratory gating system
• Varian RGSC respiratory gating system
• Open interface compatible respiratory gating systems
• Open Online interface | | • Anzai respiratory gating system
• Varian RGSC respiratory gating system
• Open interface compatible respiratory gating systems | | VB20 support acquisition of respiration-correlated scans.
For measurement of the breathing signal of the patient, interfaces for connecting of 3^{rd} party respiratory gating devices are offered.
Introduction of new Open Online Interface. |

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Table 7: Comparison of technical hardware characteristics between the subject device SOMATOM Pro.Pulse with software version syngo CT VB20 and the predicate devices SOMATOM Pro.Pulse (K232206) and SOMATOM go.Top (K233650) with software version syngo CT VB10 (K232206).

| Hardware property | Subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20 | Primary predicate device SOMATOM go.Top10 with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- |
| scanner | Whole body Computed Tomography (CT) Scanner System | Whole body Computed Tomography (CT) Scanner System | Whole body Computed Tomography (CT) Scanner System | Same as the primary and the secondary predicate device |
| System Configuration | Dual Source | Single Source | Dual Source | Same as the secondary predicate device |
| Environment of Use | Professional Healthcare Facility | Professional Healthcare Facility | Professional Healthcare Facility | Same as the primary and the secondary predicate device |
| Generator Max. power (kW) | 150 (2 x 75) | 75 | 150 (2 x 75) | Same as the secondary predicate device |
| Detector technology | Stellar detector based on Multislice UFC (Ultra Fast Ceramic) | Stellar detector based on Multislice UFC (Ultra Fast Ceramic) | Stellar detector based on Multislice UFC (Ultra Fast Ceramic) | Same as the primary and the secondary predicate device |
| Detector volume coverage | 38.4 mm | 38.4 mm | 38.4 mm | Same as the primary and secondary predicate device |
| Detector physical rows | 2 x 64 | 64 | 2 x 64 | Same as the primary and the secondary predicate device |

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| Hardware property | Subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20 | Primary predicate device SOMATOM go.Top^{10} with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- |
| Detector
Slice width | 0.6 mm | 0.6 mm | 0.6 mm | Same as the primary and secondary predicate device |
| Detector
DAS channel no. | 840 (detector A)
600 (detector B) | 840 | 840 (detector A)
600 (detector B) | Same as the secondary predicate device |
| Detector
Image slices | 2 x 128
(with Interleaved Volume Reconstruction, IVR)
2 x 384
(reconstructed slices) | 128
(with Interleaved Volume Reconstruction, IVR)
384
(reconstructed slices) | 2 x 128
(with Interleaved Volume Reconstruction, IVR)
2 x 384
(reconstructed slices) | Same as the secondary predicate device |
| Tube
technology | 2 x Athlon® DS X-ray tube | Athlon® X-ray tube | 2 x Athlon® DS X-ray tube | Same as the secondary predicate device. |
| Tube
collimator | Tube collimator DS4-A, DS4-B
• Equivalent to 0.5 mm Al in the isocenter
• 1 mm Al with cardio wedge | Tube collimator
• Equivalent to 0.5 mm Al in the isocenter
• 1 mm Al with cardio wedge | Tube collimator DS4-A, DS4-B
• Equivalent to 0.5 mm Al in the isocenter
• 1 mm Al with cardio wedge | Same as the secondary predicate device. |
| Tube
kV steps | 70–140 kV in 10 kV steps | 70–140 kV in 10 kV steps | 70–140 kV in 10 kV steps | Same as the primary and the secondary predicate device |
| Tube
Max. current | Single Source: 13-825 mA
Dual Source: 26-1650 mA | Standard range: 13 – 825 mA | Single Source: 13-825 mA
Dual Source: 26-1650 mA | Same as the secondary predicate device. |

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| Hardware property | Subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20 | Primary predicate device SOMATOM go.Top^{10} with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- |
| Tube
focus | • 0.8 × 0.8 / 7"
• 1.0 × 1.2 / 7" | • 0.8 × 0.8 / 7"
• 1.0 × 1.2 / 7" | • 0.8 × 0.8 / 7"
• 1.0 × 1.2 / 7" | Same as the primary and the secondary predicate device. |
| Tube
Heat storage capacity | 2 x 7.0 MHU | 7.0 MHU | 2 x 7.0 MHU | Same as the primary and the secondary predicate device. |
| Tube
Cooling rate (MHU/min) | up to 1.7 | up to 1.7 | up to 1.7 | Same as the primary and the secondary predicate device. |
| Gantry
Bore size | 70 | 70 | 70 | Same as the primary and the secondary predicate device |
| Gantry
Scan FoV (cm) | 50 | 50 | 50 | Same as the primary and the secondary predicate device |
| Gantry
Extended FoV (cm) | 70 | 70 | 70 | Same as the primary and the secondary predicate device |
| Gantry
Rot. time (sec) | 0.33 (optional), 0.5, 1.0 | 0.33 (optional), 0.5, 1.0 | 0.33 (optional), 0.5, 1.0 | Same as the primary and the secondary predicate device |
| Gantry
Tilt (degree) | n.a. | ± 30° | n.a. | Same as the secondary predicate device. |
| Maximum temporal | 86 ms (mono-segment) | 165 ms (mono-segment) | 86 ms (mono-segment) | Same as the secondary predicate device |

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| Hardware property | Subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20 | Primary predicate device SOMATOM go.Top^{10} with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- |
| resolution in ECG gated or triggered examination (ms) | 43 ms (bi-segment) | 82.5 ms (bi-segment) | 43 ms (bi-segment) | |
| Maximum scan speed at pitch (mm/s at pitch x) | 372 mm/s at pitch 3.2 | 175 mm/s at pitch 1.5 | 372 mm/s at pitch 3.2 | Same as the secondary predicate device |
| Patient table Type | Vario 2 (2000 mm)
Vario 2.D (2000 mm) | Vario1 (1600 mm)
Vario RT (1600 mm)
Vario 2 (2000mm) | Vario 2 (2000 mm)
Vario 2.D (2000 mm) | Same as the secondary predicate device. |
| Patient table Max. weight capacity (kg) | 307 | 227
307 | 307 | Same as the secondary predicate device. |
| Max. scan length topogram | 2080 mm with table extension | 1680 mm with table extension
2080 mm with table extension | 2080 mm with table extension | Same as the secondary predicate device. |
| Max. scan length Image acquisition | Max. 2000 mm with patient table extension | Max. 1600 mm with patient table extension
Max. 2000 mm with patient table extension | Max. 2000 mm with patient table extension | Same as the secondary predicate device. |

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| Hardware property | Subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20 | Primary predicate device SOMATOM go.Top^{10} with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- |
| Spectral filtration | Tin Filter | Combined Tin Filter / Split Filter | Tin Filter | Same as the secondary predicate device |
| FAST 3D Camera | option for patient positioning with FAST 3D Camera:
• Ceiling mounted
• Gantry mounted | option for patient positioning with FAST 3D Camera:
• ceiling mounted
• gantry mounted | option for patient positioning with FAST 3D Camera:
• Ceiling mounted
• Gantry mounted | Same as the primary and the secondary predicate device |
| High Power 70/High Power 80 | up to 825 mA (@70 kV)/up to 825 mA (@80 kV) | up to 825 mA (@70 kV)/up to 825 mA (@80 kV) | up to 825 mA (@70 kV)/up to 825 mA (@80 kV) | Same as the primary and the secondary predicate device |
| x-ray foot switch | Option to trigger hands-free scanning | Option to trigger hands-free scanning | Option to trigger hands-free scanning | Same as primary and the secondary predicate device |
| Table foot switch | Option for table patient movement | Option for table patient movement | Option for table patient movement | Same as the primary and the secondary predicate device |
| i-joystick | Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted. | Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted. | Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted. | Same as the primary and the secondary predicate device |
| Tablet dock | Option for mounting of the tablet on the patient table. | Option for mounting of the tablet on the patient table. | Option for mounting of the tablet on the patient table. | Same as the primary and the secondary predicate device |

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| Hardware property | Subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20 | Primary predicate device SOMATOM go.Top^{10} with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- |
| CARE 2D camera | one integrated into the gantry front and one mounted on the gantry back to monitor the patient during examination | one integrated into the gantry front and one mounted on the gantry back to monitor the patient during examination | one integrated into the gantry front and one mounted on the gantry back to monitor the patient during examination | Same as the primary and the secondary predicate device |
| CARE Moodlight | LED lights integrated on the gantry front cover indicating:
• System startup
• Scan countdown
• Scan | LED lights integrated on the gantry front cover indicating:
• System startup
• Scan countdown
• Radiation on | LED lights integrated on the gantry front cover indicating:
• System startup
• Scan countdown
• Radiation on | Same as the primary and the secondary predicate device.
In the subject device with syngo CT VB20, the status “Radiation on” has been renamed to “Scan”. |
| Moodlight | • Gantry ring Moodlight: ambient light during examination.
• CARE Funnel Light: ambient light which illuminates the gantry funnel | • Gantry ring Moodlight: ambient light during examination. | • Gantry ring Moodlight: ambient light during examination.
• CARE Funnel Light: ambient light which illuminates the gantry funnel | Same as the secondary predicate device |

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Table 8: Comparison of software characteristics between the subject devices with software version syngo CT VB20 and the predicate devices with software version syngo CT VB10 (K233650 and K232206).

| Software property | Subject device with SOMARIS/10 syngo CT VB20 | | Primary predicate device with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | |
| Operating System | Windows based SOMARIS/10 syngo CT VB20 Note: the short version syngo CT VB20 is also used as labeling information | Windows based SOMARIS/10 syngo CT VB20 Note: the short version syngo CT VB10 is also used as labeling information | Windows based SOMARIS/10 syngo CT VB10 Note: the short version syngo CT VB10 is also used as labeling information | Windows based SOMARIS/10 syngo CT VB10 Note: the short version syngo CT VB10 is also used as labeling information | Software version upgraded due to new functionalities. |
| Workplace | syngo Acquisition Workplace (ICS) named as “myExam Console” Image Reconstruction System (IRS) | syngo Acquisition Workplace (ICS) named as “myExam Console” Image Reconstruction System (IRS) | syngo Acquisition Workplace (ICS) named as “myExam Console” Image Reconstruction System (IRS) | syngo Acquisition Workplace (ICS) named as “myExam Console” Image Reconstruction System (IRS) | Same as the primary and secondary predicate devices |

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| Software property | Subject device with SOMARIS/10 syngo CT VB20 | | Primary predicate device with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | |
| | 2^{nd} workplace option named as “myExam Satellite” with Remote Recon function | 2^{nd} workplace option named as “myExam Satellite” with Remote Recon function | 2^{nd} workplace option named as “myExam Satellite” with Remote Recon function | 2^{nd} workplace option named as “myExam Satellite” with Remote Recon function | |
| Standard system software | • syngo Examination
• syngo Viewing
• syngo Filming
• syngo Archiving & Network | • syngo Examination
• syngo Viewing
• syngo Filming
• syngo Archiving & Network | • syngo Examination
• syngo Viewing
• syngo Filming
• syngo Archiving & Network | • syngo Examination
• syngo Viewing
• syngo Filming
• syngo Archiving & Network | Same as the primary and secondary predicate devices |
| Detector firmware | Stellar detector firmware supported | Stellar detector firmware supported | Stellar detector firmware supported | Stellar detector firmware supported | Same as the primary and secondary predicate devices |

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| Software property | Subject device with SOMARIS/10 syngo CT VB20 | | Primary predicate device with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | |
| Teamplay | Support of Teamplay protocols | Support of Teamplay protocols | Support of Teamplay protocols | Support of Teamplay protocols | Same as the primary and secondary predicate devices |
| Protocols | Support of: • Protocols for Radiation Therapy Planning support patient marking • Protocols that allow scanning with support of an external respiratory gating system | Support of: • Protocols for Radiation Therapy Planning support patient marking • Protocols supporting contrast bolus-triggered data acquisition | Support of: • Protocols for Radiation Therapy Planning support patient marking • Protocols that allow scanning with support of an external respiratory gating system | Support of: • Protocols for Radiation Therapy Planning support patient marking • Protocols supporting contrast bolus-triggered data acquisition | SOMATOM go. Platform: Same as the primary predicate devices SOMATOM Pro.Pulse: |

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| Software property | Subject device with SOMARIS/10 syngo CT VB20 | | Primary predicate device with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | |
| | • Protocol supporting contrast bolus-triggered data acquisition
• Contrast media protocols (including coronary CTA)
• Pediatric Protocols
• Flex Dose Profile
• Turbo Flash Spiral
• Dual Energy acquisition (TwinBeam DE and TwinSpiral DE)
• Dynamic imaging (Flex 4D Spiral) | • Contrast media protocols (including coronary CTA)
• Pediatric Protocols
• Flex Dose Profile
• Dynamic imaging (Flex 4D Spiral)
• interventional scan protocols (scan modes: i-sequence, i-spiral, i-Fluoro)
• Protocols supporting Cardiac Scanning, Spectral imaging for child examination, Spectral imaging with high resolution | • Protocol supporting contrast bolus-triggered data acquisition
• Contrast media protocols (including coronary CTA)
• Pediatric Protocols
• Flex Dose Profile
• Turbo Flash Spiral
• Dual Energy acquisition (TwinBeam DE and TwinSpiral DE)
• Dynamic imaging (Flex 4D Spiral) | • Contrast media protocols (including coronary CTA)
• Pediatric Protocols
• Flex Dose Profile
• Dynamic imaging (Flex 4D Spiral)
• interventional scan protocols (scan modes: i-sequence, i-spiral, i-Fluoro)
• Protocols supporting Cardiac Scanning, Spectral imaging for child examination, Spectral imaging with high resolution | Same as the secondary predicate device |

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| Software property | Subject device with SOMARIS/10 syngo CT VB20 | | Primary predicate device with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | |
| | • Protocols supporting CT Intervention (scan modes: 2D i-sequence, 3D i-sequence, i-spiral, i-Fluoro)
• Protocols supporting Cardiac Scanning
• Protocols for DirectBreathhold | • Turbo Flash Spiral
• various i-spiral and i-sequence scan protocols (applying different scanning parameters such as different slice thicknesses, kV settings or reconstructions kernels to support different clinical scenarios) and using features like iMAR, CARE Dose4D and CARE kV | • Protocols supporting CT Intervention (scan modes: i-sequence, i-spiral, i-Fluoro)
• Protocols supporting Cardiac Scanning
• Protocols for DirectBreathhold | • Turbo Flash Spiral
• various i-spiral and i-sequence scan protocols (applying different scanning parameters such as different slice thicknesses, kV settings or reconstructions kernels to support different clinical scenarios) and using features like iMAR, CARE Dose4D and CARE kV | |

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| Software property | Subject device with SOMARIS/10 syngo CT VB20 | | Primary predicate device with SOMARIS/10 syngo CT VB10 (K233650) | Secondary predicate device with SOMARIS/10 syngo CT VB10 (K232206) | Assessment of the substantial equivalency (SE) |
| --- | --- | --- | --- | --- | --- |
| | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro | SOMATOM Pro.Pulse | |
| | | • TwinkV (Dual Source Dual Energy acquisition) | | • TwinkV (Dual Source Dual Energy acquisition) | |
| Advanced Reconstruction | Recon&GO: - Spectral Recon (Dual Energy Reconstruction including Virtual Unenhanced, Monoenergetic plus) - DE SPP (Spectral Post-Processing) - Inline Anatomical ranges (Parallel/Radial) incl. Virtual | Recon&GO: - Spectral Recon (Dual Energy Reconstruction including None, low (L3D) and high (H3D) energy images) - DE SPP (Spectral Post-Processing) - Inline Anatomical ranges (Parallel/Radial) incl. Virtual | Recon&GO: - Spectral Recon (Dual Energy Reconstruction including Virtual Unenhanced, Monoenergetic plus) - DE SPP (Spectral Post-Processing) - Inline Anatomical ranges (Parallel/Radial) incl. Virtual | Recon&GO: - Spectral Recon (Dual Energy Reconstruction including None, low (L3D) and high (H3D) energy images) - DE SPP (Spectral Post-Processing) - Inline Anatomical ranges (Parallel/Radial) incl. Virtual | SOMATOM go. Platform: Same as the primary predicate devices SOMATOM Pro.Pulse: Same as the secondary predicate…