SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed

K233650 · Siemens Medical Solutions USA, Inc. · JAK · Mar 26, 2024 · Radiology

Device Facts

• Record ID: K233650
• Device Name: SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Mar 26, 2024
• 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; utilizes continuously rotating tube-detector system; fan beam principle. Inputs: X-ray transmission data. Transforms inputs via computer reconstruction into DICOM-format cross-sectional images. Used in professional healthcare facilities by trained staff (physicians, radiologists, technologists). Features include iterative reconstruction (ADMIRE, SAFIRE, iMAR), FAST/CARE/GO technologies, and optional myNeedle Guide for intervention. Output: CT images for diagnosis, treatment preparation, and therapy planning. Supports remote scan control via tablet. Benefits: enables diagnostic imaging, radiation therapy planning, and interventional guidance; provides low-dose screening capabilities.

Clinical Evidence

Bench testing only. Performance verified via phantom tests, functional integration testing, and image quality (IQ) evaluations. Bench studies confirmed accuracy of FAST 3D Camera, myNeedle Guide (90.76% needle-tip detection rate), and ZeeFree (Cardiac Stack Artefact Correction) performance. No clinical data presented.

Technological Characteristics

Whole-body CT scanner; single-source fan beam; Stellar/StellarInfinity detectors (UFC ceramic); Vectron/Athlon/Chronon X-ray tubes. Connectivity: DICOM, networked. Software: SOMARIS/10 syngo CT VB10 (Windows-based). Features: Iterative reconstruction (ADMIRE, SAFIRE, iMAR), spectral filtration (Tin/Split), FAST/CARE/GO technologies. Standards: IEC 60601-1, IEC 60601-2-44, NEMA XR 25/28, DICOM PS 3.1-3.20.

Indications for Use

Indicated for patients requiring cross-sectional imaging via CT reconstruction for diagnosis, treatment planning, 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 CT Scanner Systems with SOMARIS/10 syngo CT VA40 software (K211373)

Reference Devices

• SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB30 software (K230421)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

March 26, 2024

Siemens Medical Solutions USA, Inc. % Clayton Ginn Regulatory Affairs Professional 810 Innovation Drive KNOXVILLE, TN 37932

## Re: K233650

Trade/Device Name: SOMATOM go.Up: SOMATOM go.Now: SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 23, 2024 Received: February 23, 2024

## Dear Clayton Ginn:

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.

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).

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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 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-reportingcombination-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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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

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

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## Indications for Use

Submission Number (if known)

| K233650 |
|--------------------------------|
| Device Name |
| SOMATOM go.Up; |
| SOMATOM go.Now; |
| SOMATOM go.All; |
| SOMATOM go.Top; |
| SOMATOM go.Sim; |
| SOMATOM go.Open Pro; |
| SOMATOM X.cite; |
| SOMATOM X.ceed |
| 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)

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Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots in a pattern.

## 510(k) Summary for K233650

# SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems

with software version SOMARIS/10 syngo CT VB10

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 Healthcare GmbH 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.

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Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

#### Submitter Contact Person:

Clayton Ginn Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: [phone] [e-mail] Backup Contact: Kenny 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.Up | SOMATOM go.Up |
| SOMATOM go.Now | SOMATOM go.Now |
| 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 X.cite | SOMATOM X.cite |
| SOMATOM X.ceed | SOMATOM X.ceed |
| 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 CT Scanner Systems with SOMARIS/10 syngo CT VA40<br>software |
| 510(k) Number: | K211373 |
| Clearance Date: | August 27, 2021 |
| 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<br>design. |

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Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots arranged in a pattern.

| Reference device: | |
|-----------------------|------------------------------------------------------------------------------------|
| Trade Name: | SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB30<br>software |
| 510(k) Number: | K230421 |
| Clearance Date: | June 16, 2023 |
| 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<br>design. |

#### Note:

K211373 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.

K230421 was a bundle submission with various Siemens CT Scanner Systems, including the dual source CT scanner systems SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash and the single source CT scanner CT systems SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open.

## IV. Device Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

SOMATOM go. Platform CT scanner systems:

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

SOMATOM X. Platform CT scanner systems:

- . SOMATOM X.cite
- . SOMATOM X.ceed

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

The subject devices SOMATOM go. Platform and SOMATOM X. Platform with SOMARIS/10 syngo CT VB10 are Computed Tomography X-ray Systems which feature one continuously rotating tubedetector system and function according to the fan beam principle (single source). The SOMATOM go. Platform and SOMATOM X. Platform with software SOMARIS/10 syngo CT VB10 produces CT

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Image /page/6/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots of varying sizes.

images in DICOM format, which can be used by trained staff for 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.

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 platform software for the SOMATOM go. Platform and SOMATOM X. Platform, SOMARIS/10 synqo CT VB10, is a command-based program used for patient management, data management, Xray scan control, image reconstruction, and image archive/evaluation.

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 VB10 (SOMARIS/10 syngo CT VB10) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the predicate device in K211373.

Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as an optional upgrade for the applicable existing SOMATOM go. Platform and SOMATOM X. Platform 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.

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Image /page/7/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" are several orange dots arranged in a circular pattern.

## 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*.

*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 physician as an aid in diagnosis.

The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.

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

High risk populations are 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 reference predicate's Indications for Use (K230421), however it is slightly different than the primary predicate's Indications for Use.

- 1. The sentence "The images delivered by the system can be used by a trained physician as an aid in diagnosis" was removed, since the subsequent sentence restates the same, replacing 'trained physician' with 'trained staff'. It can be assumed a trained physician is part of the trained staff.
To consider that in the US, the standard of care is for physicians to perform diagnosis/treatment, Siemens added the following statement in the Device Description above and an equivalent warning exists in the labeling:

"Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists. 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."

- 2. The word 'preparation' has been removed from the phrase "treatment preparation and radiation therapy planning" since treatment planning better describes how the device is used.

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Image /page/8/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

- 3. The phrase "as well as for diagnostic and therapeutic interventions" was added to the second sentence. This was done to express use of the device in standard practice. This device can and is commonly used as an aid in invasive procedures.
None of the intended use includes computed tomography as the principal means of guidance in invasive procedures (involving the introduction of a device, such as a needle or a catheter into the body of the patient).

The subject devices SOMATOM go. Platform and SOMATOM X. Platform are not the principal means of guidance, because the CT Systems do not guide the invasive procedures, the needle orientation and the needle advance and handling is always done under the physicians control.

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

Supported by the subject device, SOMARIS/10 syngo CT VB10 software version is a further development of the SOMARIS/10 syngo CT VA40 software version which is cleared in K211373.

The SOMATOM go. Platform and the SOMATOM X. Platform with SOMARIS/10 syngo CT VB10 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 SOMATOM go. Platform and SOMATOM X. Platform have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices.

The new syngo CT VB10 software reuses all unmodified software features of the legacy software syngo CT VA40 cleared in K211373. Additionally, no features present in the predicate device are descoped.

Software version SOMARIS/10 syngo CT VB10 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 X. Platform 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
- . Vectron/Athlon/Chronon X-ray Tube depending on the CT system
- Power Generator
- Scan&GO
- Mobile workflow (Tablet)
- Optional injector arm

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Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots that are arranged in a circular pattern.

- Optional support of CT guided intervention workflow (myNeedle Guide) ●
- . Optional support of FAST 3D Camera operation for fast patient positioning workflow
- . Scanner display and control functionality
- Remote Scan Control
- . Respiratory Gating Devices
- . Standard CARE technologies
- Standard FAST technologies
- Standard GO technologies
- . Precision matrix (large image matrices)
- HD FoV
- DirectDensity™ ●

Compared to the primary predicate device referenced in this submission, the subject devices SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems with SOMARIS/10 syngo CT VB10 support the modifications provided in the Table 3 under subsection 1) Modified Hardware and Table 4 under subsection 2) Modified Software.

The configuration table and comparison table use the following terms in Table 2 to describe various technological characteristics in comparison to the primary and secondary predicate devices information:

| Term | Definition |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| N/A | The feature is not supported for the subject device |
| New | The feature is newly supported for Siemens CT Scanners and newly introduced<br>within the subject device submission |
| Unmodified | The feature remains unchanged from that within the predicate device. The<br>relevant modification was already present within the predicate device. |
| Modified | This feature is modified from the predicate / reference devices |
| Enabled | This feature is currently supported by other cleared Siemens CT systems or<br>cleared Siemens stand-alone software applications. This feature will be<br>supported for the subject device with software version SOMARIS/10 syngo CT<br>VB10 and is substantially equivalent compared to the cleared version of the<br>primary/reference predicate device. |

Table 2: Overview of term definition.

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Image /page/10/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots.

#### 1) Modified Hardware

Table 3: Overview of hardware modifications of SOMATOM go. Platform and SOMATOM X. Platform CT scanner systems with SOMARIS/10 syngo CT VB10.

| # | Hardware<br>property | Subject devices<br>with SOMARIS/10 syngo CT VB10 | | |
|----|--------------------------------|---------------------------------------------------------------------|---------------------------------------|----------------------------------|
| | | SOMATOM go. Platform | | SOMATOM X. Platform |
| | | SOMATOM go.Now<br>SOMATOM go.Up<br>SOMATOM go.All<br>SOMATOM go.Top | SOMATOM go.Sim<br>SOMATOM go.Open Pro | SOMATOM X.cite<br>SOMATOM X.ceed |
| 1. | FAST 3D Camera | enabled | enabled | enabled |
| 2. | CARE Breathe | enabled | N/A | unmodified |
| 3. | CARE 2D Camera | enabled | unmodified | unmodified |
| 4. | Moodlight | enabled | unmodified | unmodified |
| 5. | CARE Moodlight | enabled | N/A | N/A |
| 6. | Multi-Purpose<br>Table (Vitus) | N/A | N/A | modified |

## 2) Modified Software (syngo CT VB10)

Table 4: Overview of software modifications of SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems with SOMARIS/10 syngo CT VB10.

| # | Software property | Subject devices<br>with SOMARIS/10 syngo CT VB10 | | | | | |
|----|-----------------------------------|--------------------------------------------------|------------------|----------------------------------------|-------------------|------------------------|----------------------------------------|
| | | SOMATOM go. Platform | | | | SOMATOM<br>X. Platform | |
| | | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.All<br>SOMATOM<br>go.Top | SOMATOM<br>go.Sim | SOMATOM<br>go.Open Pro | SOMATOM<br>X.cite<br>SOMATOM<br>X.ceed |
| 1. | DirectBreathhold | N/A | enabled | enabled | enabled | enabled | enabled |
| 2. | ZeeFree | N/A | N/A | enabled | enabled | enabled | enabled |
| 3. | myNeedle Guide | enabled | enabled | enabled | enabled | enabled | enabled |
| 4. | FAST Integrated<br>Workflow | enabled | enabled | enabled | enabled | enabled | enabled |
| 5. | Direct i4D | N/A | N/A | N/A | N/A | modified | modified |
| 6. | myExam<br>Companion | enabled | modified | modified | modified | modified | modified |
| 7. | myExam Satelite<br>(Remote Recon) | enabled | enabled | enabled | enabled | enabled | enabled |
| 8. | Recon&GO | modified | modified | modified | modified | modified | modified |

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Image /page/11/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots that are arranged in a circular pattern.

| # | Software property | Subject devices<br>with SOMARIS/10 syngo CT VB10 | | | | | |
|-----|----------------------------------|--------------------------------------------------|------------------|----------------------------------------|-------------------|------------------------|----------------------------------------|
| | | SOMATOM go. Platform | | | | | SOMATOM<br>X. Platform |
| | | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.All<br>SOMATOM<br>go.Top | SOMATOM<br>go.Sim | SOMATOM<br>go.Open Pro | SOMATOM<br>X.cite<br>SOMATOM<br>X.ceed |
| 9. | CT View&GO | enabled | enabled | enabled | enabled | enabled | enabled |
| 10. | Scan&GO | enabled | enabled | enabled | enabled | enabled | enabled |
| 11. | Automatic Patient<br>instruction | enabled | enabled | enabled | enabled | enabled | enabled |
| 12. | DirectSetup Notes | N/A | N/A | N/A | new | new | N/A |
| 13. | ADMIRE | N/A | N/A | unmodified | enabled | enabled | unmodified |

A tabular summary of the comparable hardware and software properties between the subject devices SOMATOM go. Platform and SOMATOM X. Platform with software version syngo CT VB10 and primary/reference predicate devices are listed in Table 9 below (modifications are in gray shaded sections).

Table 5: Comparison of technical hardware characteristics between subject devices SOMATOM go.Now and SOMATOM go.Up with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40.

| Hardware property | Subject device<br>SOMATOM go. Platform<br>with SOMARIS/10 syngo CT VB10 | | Primary predicate device<br>SOMATOM go. Platform<br>with SOMARIS/10 syngo CT VA40<br>(K211373) | |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.Now | SOMATOM<br>go.Up |
| scanner | Whole body Computed Tomography<br>(CT) Scanner System | Whole body Computed Tomography<br>(CT) Scanner System | Whole body Computed Tomography<br>(CT) Scanner System | Whole body Computed Tomography<br>(CT) Scanner System |
| System<br>Configuration | Single Source | | Single Source | |
| Environment of Use | Professional Healthcare Facility | | Professional Healthcare Facility | |
| Generator<br>Max. power (kW) | 32 | | 32 | |
| Detector<br>technology | Stellar<br>based on UFC (Ultra Fast Ceramic) | | Stellar<br>based on UFC (Ultra Fast Ceramic) | |
| Detector<br>volume coverage<br>(mm) | 11.2 | 22.4 | 11.2 | 22.4 |
| Detector | 16 | 32 | 16 | 32 |
| Hardware property | Subject device<br>SOMATOM go. Platform<br>with SOMARIS/10 syngo CT VB10 | | Primary predicate device<br>SOMATOM go. Platform<br>with SOMARIS/10 syngo CT VA40<br>(K211373) | |
| | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.Now | SOMATOM<br>go.Up |
| physical rows | | | | |
| Detector<br>Slice width (mm) | 0.7 | | 0.7 | |
| Detector<br>DAS channel no. | 768 | | 768 | |
| Detector<br>Image slices | 32 | 64 | 32 | 64 |
| Tube<br>technology | Chronon | | Chronon | |
| Tube<br>kV steps | 80, 110, 130 | | 80, 110, 130 | |
| Tube<br>Max. current (mA) | 400 | | 400 | |
| Tube<br>focus | • 0.8 x 0.4 / 8°<br>• 0.8 x 0.7 / 8° | | • 0.8 x 0.4 / 8°<br>• 0.8 x 0.7 / 8° | |
| Tube<br>Heat storage<br>capacity (MHU) | 3.5 | | 3.5 | |
| Tube<br>Cooling rate (kHU/<br>min) | 915 | | 915 | |
| Gantry<br>Bore size | 70 | | 70 | |
| Gantry<br>Scan FoV (cm) | 50 | | 50 | |
| Gantry<br>Extended FoV (cm) | 70 | | 70 | |
| Gantry<br>Rot. time (sec) | 0.5, 0.8, 1.0, 1.5 | | 0.8, 1.0, 1.5 | |
| Gantry<br>Tilt (degree) | N/A | +/- 30°<br>-30° to +28° with<br>optional 307 kg | N/A | +/- 30°<br>-30° to +28° with<br>optional 307 kg |
| Hardware property | Subject device<br>SOMATOM go. Platform<br>with SOMARIS/10 syngo CT VB10 | | Primary predicate device<br>SOMATOM go. Platform<br>with SOMARIS/10 syngo CT VA40<br>(K211373) | |
| | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.Now | SOMATOM<br>go.Up |
| | | patient table | | patient table |
| Patient table<br>Type | Vector (1250<br>mm),<br>Vario 1 (1600<br>mm),<br>Vario RT (1600<br>mm)<br>with table<br>extension | Vario 1 (1600<br>mm),<br>Vario 2 (2000<br>mm),<br>Vario RT (1600<br>mm)<br>with table<br>extension | Vector (1250<br>mm),<br>Vario 1 (1600<br>mm),<br>Vario RT (1600<br>mm)<br>with table<br>extension | Vario 1 (1600<br>mm),<br>Vario 2 (2000<br>mm),<br>Vario RT (1600<br>mm)<br>with table<br>extension |
| Patient table<br>Max. weight<br>capacity (kg) | Vector: 160<br>Vario 1: 227<br>Vario RT: 227 | Vario 1: 227<br>Vario 2: 307<br>Vario RT: 227 | Vector: 160<br>Vario 1: 227<br>Vario RT: 227 | Vario 1: 227<br>Vario 2: 307<br>Vario RT: 227 |
| Max. scan length<br>topogram | 1680 mm with<br>table extension | 1680 mm with<br>table extension<br>2080 mm with<br>table extension | 1680 mm with<br>table extension | 1680 mm with<br>table extension<br>2080 mm with<br>table extension |
| Max. scan length<br>Image acquisition | Max. 1600 mm<br>with patient<br>table extension | Max. 1600 mm<br>with patient<br>table extension<br>Max. 2000 mm<br>with patient<br>table extension | Max. 1600 mm<br>with patient<br>table extension | Max. 1600 mm<br>with patient<br>table extension<br>Max. 2000 mm<br>with patient<br>table extension |
| Spectral filtration | Tin Filter | | Tin Filter | |
| High Power 80 | yes | yes | yes | yes |
| FAST 3D Camera | option for<br>patient<br>positioning with<br>3D Camera:<br>• gantry<br>mounted,<br>modified<br>design | option for<br>patient<br>positioning with<br>3D Camera:<br>• ceiling<br>mounted,<br>modified<br>design<br>• gantry<br>mounted,<br>modified<br>design | n.a. | option for<br>patient<br>positioning with<br>3D Camera:<br>• ceiling<br>mounted |
| Hardware property | Subject device<br>SOMATOM go. Platform<br>with SOMARIS/10 syngo CT VB10 | | Primary predicate device<br>SOMATOM go. Platform<br>with SOMARIS/10 syngo CT VA40<br>(K211373) | |
| | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.Now | SOMATOM<br>go.Up |
| x-ray foot switch | Option to trigger hands-free<br>scanning | Option to trigger hands-free<br>scanning | Option to trigger hands-free<br>scanning | Option to trigger hands-free<br>scanning |
| Table foot switch | Option for table patient movement | Option for table patient movement | Option for table patient movement | Option for table patient movement |
| i-joystick | Option for patient table<br>movements, including an electrical<br>connection for the tablet dock<br>which allows charging the tablet<br>when mounted. | Option for patient table<br>movements, including an electrical<br>connection for the tablet dock<br>which allows charging the tablet<br>when mounted. | Option for patient table<br>movements, including an electrical<br>connection for the tablet dock<br>which allows charging the tablet<br>when mounted. | Option for patient table<br>movements, including an electrical<br>connection for the tablet dock<br>which allows charging the tablet<br>when mounted. |
| Tablet dock | Option for mounting of the tablet<br>on the patient table. | Option for mounting of the tablet<br>on the patient table. | Option for mounting of the tablet<br>on the patient table. | Option for mounting of the tablet<br>on the patient table. |
| CARE Breathe | visualization of breathing<br>instructions to support three<br>messages in respiratory motion<br>management:<br>• free breathing<br>• preparation for breath hold<br>• breath hold itself in<br>combination with the<br>visualization of a countdown<br>visual patient instruction unit is<br>placed on the gantry front and<br>gantry back in the gantry funnel | | visual countdown indicator to<br>provide visual instruction in<br>respiratory motion management:<br>• free breathing<br>• preparation for hold breath<br>• breath hold<br>visual countdown indicator is placed<br>on the halo | |
| CARE 2D camera | one integrated into the gantry front<br>and one mounted on the gantry<br>back to monitor the patient during<br>examination | | 2D camera* integrated on the halo<br>plate<br>*in syngo CT VA40 known as patient<br>observation camera | |
| Moodlight | Illumination Moodlight to enhance<br>patient comfort supported<br>integrated as a ring with LED light<br>into the gantry front |…