SOMATOM On.site

K241295 · Siemens Medical Solutions USA, Inc. · JAK · Sep 3, 2024 · Radiology

Device Facts

• Record ID: K241295
• Device Name: SOMATOM On.site
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Sep 3, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck. The images delivered by the system can be used by a trained staff as an aid in diagnosis.

Device Story

Mobile CT scanner; continuously rotating tube-detector system; fan beam principle. Two variants: ICU (motorized trolley) and MSU (vehicle-mounted). Inputs: X-ray transmission data. Transforms data via SOMARIS/10 syngo CT VB10 software; iterative reconstruction (ADMIRE). Outputs: DICOM CT images. Used in ICU, ER, mobile stroke units; operated by physicians, radiologists, or technologists. Healthcare providers use images for diagnosis and treatment preparation. Benefits: Point-of-care imaging; reduced dose via CARE Dose4D, X-CARE, and tin filtration; improved workflow via automated tools.

Clinical Evidence

Bench testing only. Performance evaluated via phantom measurements for image quality (CNR, noise, MTF), radiation dose (CTDIvol), and algorithm functionality (ADMIRE, FAST kV, CARE Dose4D, X-CARE). Results demonstrate consistency with predicate performance and established dose reduction capabilities.

Technological Characteristics

Mobile CT; 32-row Stellar detector; 26 cm FoV; 35 cm bore. Stationary anode tube; liquid cooling. 1.0s rotation. 1x 48V Li-ion battery. Connectivity: DICOM. Software: SOMARIS/10 syngo CT VB10 (Windows-based). Standards: IEC 60601-1, 60601-2-44, 61223-3-5, DICOM PS 3.1-3.20.

Indications for Use

Indicated for generating and processing cross-sectional head and neck images via computed reconstruction of x-ray transmission data for use by trained staff as an aid in diagnosis.

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 On. CT scanner systems (K193277)
• SOMATOM go.Up (K233650)

Submission Summary (Full Text)

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September 3, 2024

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

Re: K241295

Trade/Device Name: SOMATOM On.site Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: July 31, 2024 Received: July 31, 2024

Dear Kenny 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.

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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 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.

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-device-advicecomprehensive-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-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-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

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic 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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# Indications for Use

Submission Number (if known)

K241295

Device Name

SOMATOM On.site

Indications for Use (Describe)

This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.

The images delivered by the system can be used by a trained staff as an aid in diagnosis.

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/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 cluster of orange dots.

# 510(k) Summary for K241295

# SOMATOM On.site CT Scanner System

# 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

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

Note: Descriptions in this submission use the short company name Siemens. Brand name on all products is 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]

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Image /page/5/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 pattern of orange dots arranged in a circular shape.

# II. Device Name and Classification

| Product name: | SOMATOM On.site |
|-----------------------|----------------------------------|
| Trade name: | SOMATOM On.site |
| 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 On. CT scanner systems<br>(with SOMARIS/10 syngo CT VA35 software) |
|-----------------------|------------------------------------------------------------------------------------|
| 510(k) Number: | K193277 |
| Clearance Date: | July 22, 2020 |
| 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. |

#### Secondary predicate device:

| Trade Name: | SOMATOM go.Up (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<br>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.

K193277 was a bundle submission with the following Siemens CT Scanner Systems: SOMATOM On.site and SOMATOM On.scene

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Image /page/6/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 cluster of orange dots arranged in a circular pattern.

# IV. Device Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the SOMATOM On. platform cleared in K193277 (clearance date July 22nd, 2020).

In software version syngo CT VA35 (K193277), the SOMATOM On. platform consists of two Computer Tomography (CT) scanner systems: SOMATOM On.scene for Mobile Stroke Units and SOMATOM On.site with an optional motorized base for in-hospital usage.

With the new software version SOMARIS/10 synqo CT VB10, the two SOMATOM On. scanners are rebranded as one scanner model only, SOMATOM On.site. The brand name SOMATOM On.scene is not used anymore.

The SOMATOM On.site with software version syngo CT VB10 is a mobile computed tomography (CT) scanner system that will be offered in two variants:

- . SOMATOM On.site for Intensive Care Unit (ICU) Mobile CT scanner affixed to a motorized trolley for use in hospital situations. The scanner can be moved from patient bed to patient bed to perform scanning at the point of care. Although it might be used in other environments like emergency rooms or angiography labs, the main location where this scanner will be used, will be the intensive care unit (ICU).
- . SOMATOM On.site for Mobile Stroke Unit (MSU) Mobile CT Scanner that is mounted to the floor of a diagnostic room or vehicle. The system main place where the scanner will be mounted is in a mobile stroke unit (MSU), which is a specific type of ambulance.

# SOMATOM On.site

SOMARIS/10 syngo CT VB10

A: for Intensive Care Unit (ICU)

Image /page/6/Figure/11 description: This image shows a Siemens Healthineers SOMATOM On.site mobile CT scanner. The scanner is white with orange accents and has a large, circular gantry. The gantry is open in the front, and there is a gray cover over the opening. The scanner is mounted on a wheeled base, making it easy to move around.

B: for Mobile Stroke Unit (MSU)

Image /page/6/Figure/13 description: The image shows a Siemens Healthineers SOMATOM On.site mobile head CT scanner. The scanner is white with an orange circular opening where the patient's head is placed for scanning. The Siemens Healthineers logo is visible at the top of the scanner.

Figure 1: SOMATOM On.site with software version SOMARIS/10 syngo CT VB10 in two variants. A: as a mobile CT scanner for Intensive Care Unit (ICU). The scanner is mounted on a trolley with wheels. B: as a mobile CT for Mobile Stroke Unit (MSU). The CT scanner is mounted in a vehicle.

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Image /page/7/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 graphic of orange dots arranged in a circular pattern.

The subject device SOMATOM On.site with SOMARIS/10 syngo CT VB10 is a mobile Computed Tomography X-ray Systems which features a continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM On.site with software SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for postprocessing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis and treatment preparation. The computer system integrated 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. 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 SOMATOM On.site is syngo CT VB10 (SOMARIS/10 syngo CT VB10). It is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform SOMARIS/10 synqo CT VB10 is designed to provide a plugin interface to integrate potential advanced post-processing tasks, tools, or extendable functionalities.

New software version synqo CT VB10 (SOMARIS/10 synqo CT VB10) is a modified software version based on syngo CT VA35 (SOMARIS/10 syngo CT VA35) which was cleared for the predicate device in K193277.

Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as a mandatory exchange for the applicable existing SOMATOM On.site.

The subject device SOMATOM On.site will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use is same for subject and primary predicate device.

# V. Indications for Use

This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.

The images delivered by the system can be used by a trained staff as an aid in diagnosis.

## VI. Indications for Use Comparison

#### Subject Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.

The images delivered by the system can be used by a trained staff as an aid in diagnosis.

#### Primary Predicate Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 25 cm field-of-view, primarily for the head and neck.

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Image /page/8/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. To the right of the word "Healthineers" is a graphic of orange dots.

The images delivered by SOMATOM On.site and On.scene can be used by a trained physician as an aid in diagnosis.

#### 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.

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:

#### Compared to the primary predicate device:

In the sentence "This computed tomography system is intended to generate and process crosssectional images by computed reconstruction of x-ray transmission data within a 25 cm field-of-view, for the head and neck.":

- . "25 cm field-of-view" is replaced with "26 cm field-of-view". The field-of-view was inconsistently listed among the documents of the predicate device. However, 26 cm field-ofview is the correct field-of-view of the predicate device and the subject device.
- . "primarily for the head and neck" is replaced with "for the head and neck". In contrast to the predicate device, the subject device is only intended for head and neck scans.

In the sentence "The images delivered by SOMATOM On.scene can be used by a trained physician as an aid in diagnosis ":

- . "trained physician" is replaced 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 510(k) summary:

"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."

- . "SOMATOM On.site and SOMATOM On.scene" have been replaced with "system", since with software version synqo CT VB10, the two SOMATOM On. scanners will be rebranded as one scanner model only.

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Image /page/9/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 below it. To the right of the word "Healthineers" are several orange dots arranged in a pattern.

#### Compared to the secondary predicate device:

- The subject device does not contain the phrase "treatment preparation and radiation therapy planning" in the sentence "The images delivered by the system can be used by a trained staff as an aid in diagnosis." because SOMATOM On.site does not support intervention procedures and radiation therapy planning.
- . SOMATOM On.site is not used in lung cancer screening. Therefore, the following part is not included in the indication for use statement of SOMATOM On.site.

"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."

# 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 VA35 software version which is cleared in K193277.

The SOMATOM On.site 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 On.site 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 VA35 cleared in K193277.

The intended use and fundamental scientific technology for the SOMATOM On.site remain unchanged from the predicate devices.

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

- System Acquisition - Continuously rotating tube detector system
- . Iterative Reconstruction – Support of various iterative reconstruction principles
- A gantry translation system
- Stellar Detector technology
- Tin filtration technology
- Power Generator
- Remote Scan Control
- Standard CARE technologies
- Standard FAST technologies
- Standard GO technologies
- HD FoV ●

Compared to the predicate devices referenced in this submission, the subject device SOMATOM On.site with SOMARIS/10 syngo CT VB10 support the following modifications:

- 1) Modified hardware
- 2) Modified software
- 3) Modified accessories

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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 below it. To the right of the word "Healthineers" are several orange dots that are arranged in a pattern.

- 4) Modified indications for use
- 5) Rebranding as one scanner model with two configurations, ICU and MSU

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

Table 1: Overview of term definition

| Term | Definition |
|----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Modified | The feature is modified from the predicate devices |
| Enabled | The feature is currently supported by other cleared Siemens CT systems. This<br>feature will be supported for the subject device with software version<br>SOMARIS/10 syngo CT VB10 and is unmodified from cleared version. |
| New | The feature is newly supported for Siemens CT Scanners and the subject<br>device |

#### 1) Modified Hardware

Table 2: Overview of hardware modifications of SOMATOM On.site with software version SOMARIS/10 syngo CT VB10 compared to the predicate devices.

| # | Hardware property | Subject device |
|----|-------------------------|----------------------------------------------------------------------------|
| | | SOMATOM On.Site<br>(ICU and MSU variants)<br>with SOMARIS/10 syngo CT VB10 |
| 1. | CARE 2D Camera | modified<br>(compared to the secondary predicate<br>device SOMATOM go.Up) |
| 2. | Tin Filter for Topogram | enabled<br>(compared to the secondary predicate<br>device SOMATOM go.Up) |

#### 2) Modified Software (syngo CT VB10)

Table 3: Overview of software modifications of SOMATOM On.site with software version SOMARIS/10 syngo CT VB10 compared to the predicate devices.

| # | Software property | Subject device |
|-----|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| | | SOMATOM On.Site<br>(ICU and MSU variants)<br>with SOMARIS/10 syngo CT VB10 |
| 1. | Check&GO – Metal detection | enabled |
| # | Software property | Subject device |
| | | SOMATOM On.Site<br>(ICU and MSU variants)<br>with SOMARIS/10 syngo CT VB10<br>(compared to the secondary predicate<br>device SOMATOM go.Up) |
| 2. | myExam Companion - myExam<br>Compass/myExam Cockpit | enabled<br>(compared to the secondary predicate<br>device SOMATOM go.Up) |
| 3. | Bolus Tracking | enabled<br>(compared to the secondary predicate<br>device SOMATOM go.Up) |
| 4. | Test Bolus | enabled<br>(compared to the secondary predicate<br>device SOMATOM go.Up) |
| 5. | ADMIRE | enabled<br>(compared to the secondary predicate<br>device SOMATOM go.Up) |
| 6. | FAST kV | enabled<br>(compared to the secondary predicate<br>device SOMATOM go.Up) |
| 7. | CARE Dose4D | enabled<br>(compared to the secondary predicate<br>device SOMATOM go.Up) |
| 8. | X-CARE | enabled<br>(compared to the secondary predicate<br>device SOMATOM go.Up) |
| 9. | FAST Planning | enabled<br>(compared to the secondary predicate<br>device SOMATOM go.Up) |
| 10. | CT View&GO | modified<br>(compared to the primary SOMATOM<br>on.site and the secondary predicate device<br>SOMATOM go.Up) |
| 11. | Recon&GO | modified<br>(compared to the primary SOMATOM<br>on.site and the secondary predicate device<br>SOMATOM go.Up) |

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Image /page/11/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 graphic of orange dots arranged in a circular pattern.

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Image /page/12/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. To the right of the word "Healthineers" is a graphic of orange dots.

A tabular summary of the comparable hardware properties between the subject device On.site with software version syngo CT VB10 and the predicate devices are listed in Table 5 below (modifications are in gray shaded sections).

Toble 4: Comprison of hardware (HV) technologics between the subject device SOMATOM On.site with syltware version syngo CTVB10 ond the predicote devices.

| Hardware (HW)<br>property | Subject device<br>SOMATOM On.site<br>SOMARIS/10 syngo CT VB10 | Primary predicate device<br>SOMATOM On. scanners<br>SOMARIS/10 syngo CT VA35<br>(K193277) | Secondary predicate device<br>SOMATOM go.Up<br>SOMARIS/10 syngo CT VB10<br>(K233650) | Assessment of the<br>substantial<br>equivalency (SE) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Scanner | Head sized computed<br>tomography scanner with<br>continuously rotating tube<br>and detector | Head sized computed<br>tomography scanner with<br>continuously rotating tube<br>and detector | Whole body computed<br>tomography scanner with<br>continuously rotating tube<br>and detector | Same as the primary<br>predicate device |
| System configuration | Single source | Single source | Single source | Same as the primary<br>and the secondary<br>predicate device |
| Use environment | Radiology suite, Operating<br>room (OR), Emergency<br>Department/ Emergency room<br>(ER/ED), clinic, patient rooms,<br>exam rooms, mobile radiology<br>vehicles, Intensive Care Unit<br>(ICU), and Mobile Stroke Unit<br>(MSU) | Radiology suite, Operating<br>room (OR), Emergency<br>Department/ Emergency room<br>(ER/ED), clinic, patient rooms,<br>exam rooms, mobile radiology<br>vehicles, Intensive Care Unit<br>(ICU), and Mobile Stroke Unit<br>(MSU) | Professional Healthcare<br>Facility | Same as the primary<br>predicate device |
| X-ray tube | Stationary anode | Stationary anode | Rotary anode | Same as the primary<br>predicate device |
| Tube<br>technology | Monoblock: Integrates tube<br>and generator to one<br>component | Monoblock: Integrates tube<br>and generator to one<br>component | Chronon | Same as the primary<br>predicate device |
| Hardware (HW)<br>property | Subject device<br>SOMATOM On.site<br>SOMARIS/10 syngo CT VB10 | Primary predicate device<br>SOMATOM On. scanners<br>SOMARIS/10 syngo CT VA35<br>(K193277) | Secondary predicate device<br>SOMATOM go.Up<br>SOMARIS/10 syngo CT VB10<br>(K233650) | Assessment of the<br>substantial<br>equivalency (SE) |
| Tube<br>current (mA) | 1...25 | 3...25 | 13...400 | Range of mA was<br>extended at the lower<br>end to increase<br>flexibility for scans with<br>lower mA and thus<br>lower dose especially<br>for topogram scans. |
| Tube voltage<br>kV steps | 80, 120 | 80, 120 | 80, 110, 130 | Same as the primary<br>predicate device |
| tube cooling | Liquid | Air and liquid | Liquid | Same as the secondary<br>predicate device<br>Focus on liquid cooling<br>allows to get rid of air<br>cooling and reduce the<br>number of<br>components in the<br>system by reducing the<br>air fan, which was<br>needed. |
| Focal spot size (mm) | 1.1 x 1.6 | 1.1 x 1.6 | 0.8 x 0.4<br>0.8 x 0.7 | Same as the primary<br>predicate device |
| Generator<br>power max (kW) | 3 | 3 | 32 | Same as the primary<br>predicate device |
| Hardware (HW)<br>property | Subject device<br>SOMATOM On.site<br>SOMARIS/10 syngo CT VB10 | Primary predicate device<br>SOMATOM On. scanners<br>SOMARIS/10 syngo CT VA35<br>(K193277) | Secondary predicate device<br>SOMATOM go.Up<br>SOMARIS/10 syngo CT VB10<br>(K233650) | Assessment of the<br>substantial<br>equivalency (SE) |
| Detector<br>material | Lightning UFC | Lightning UFC | Lightning UFC | Same as the primary<br>and the secondary<br>predicate device |
| Detector<br>technology | Stellar based technology | Stellar based technology | Stellar based technology | Same as the primary<br>and the secondary<br>predicate device |
| Detector<br>physical rows | 32 | 32 | 32 | Same as the primary<br>and the secondary<br>predicate device |
| Detector<br>Z axis coverage (mm) | 24 | 24 | 22.4 | Same as the primary<br>and the secondary<br>predicate device |
| Detector<br>slice width (mm) | 0.75 | 0.75 | 0.7 | Same as the primary<br>predicate device |
| Detector<br>DAS channel No./row | 416 | 416 | 768 | Same as the primary<br>predicate device |
| Detector<br>Max. number of slices | Acquired: 32<br>Reconstructed: 32 | Acquired: 32<br>Reconstructed: 32 | Acquired: 32<br>Reconstructed: 64 | Same as the primary<br>predicate device |
| Translation/table | Translation on fixed base | Translation on fixed base | Translating patient table | Same as the primary<br>predicate device |
| Max. scan range (cm) | 25 | 25 | 160 or 200 depending on the<br>patient table used | Same as primary<br>predicate device |
| Hardware (HW)<br>property | Subject device<br>SOMATOM On.site<br>SOMARIS/10 syngo CT VB10 | Primary predicate device<br>SOMATOM On. scanners<br>SOMARIS/10 syngo CT VA35<br>(K193277) | Secondary predicate device<br>SOMATOM go.Up<br>SOMARIS/10 syngo CT VB10<br>(K233650) | Assessment of the<br>substantial<br>equivalency (SE) |
| | | | | |
| Gantry<br>scan FoV (cm) | 26 | 26 | 50 | Same as the primary<br>predicate device |
| Gantry<br>rotation time (sec) | 1.0 | 1.0 | 0,8, 1.0, 1.5 | Same as the primary<br>predicate device |
| Gantry<br>bore diameter (cm) | 35 | 35 | 70 | Same as the primary<br>predicate device |
| Gantry tilt (degrees) | No tilt | No tilt | Yes (+/-25°) | Same as the primary<br>predicate device |
| Selectable filtration | Tin Filter/Tin Filtration<br>technology | N.A. | Tin Filter/Tin Filtration<br>technology | Same as the secondary<br>predicate device<br>Tin filtration allows to<br>lower the dose on<br>topogram scans. |
| Recon speed<br>(images/sec) | 20 for FBP | 13 for FBP | • 30 fps for FBP<br>• 75 fps for FBP<br>(depending on the IRS) | Recon speed increased<br>due to new hardware<br>(image reconstruction<br>system) with increased<br>performance |
| Spiral scan | yes | yes | yes | Same as the primary<br>predicate device |
| Hardware (HW)<br>property | Subject device<br>SOMATOM On.site<br>SOMARIS/10 syngo CT VB10 | Primary predicate device<br>SOMATOM On. scanners<br>SOMARIS/10 syngo CT VA35<br>(K193277) | Secondary predicate device<br>SOMATOM go.Up<br>SOMARIS/10 syngo CT VB10<br>(K233650) | Assessment of the<br>substantial<br>equivalency (SE) |
| System Configuration | Single source | Single source | Single source | Same as the primary<br>predicate device |
| Patient support | Patient support mounts<br>directly to the scanner and is<br>pre-aligned to alleviate<br>imaging artifacts or loss of<br>quality | Patient support mounts<br>directly to the scanner and is<br>pre-aligned to alleviate<br>imaging artifacts or loss of<br>quality | Patient support is part of<br>patient table which is<br>mounted to scanner and is<br>pre-aligned laterally; requires<br>operator to align vertically to<br>center patient to alleviate<br>imaging artifacts or loss of<br>quality | Same as the primary<br>predicate device |
| Radiation shielding | Yes<br>Gantry shielded internally with<br>lead<br>Externally contain lead lined<br>full-length drapes to entirely<br>contain the scattered<br>radiation from all angles<br>Operator can stand at side of<br>machine.<br>Wearing of protective<br>shielding is optional. | Yes<br>Gantry shielded internally with<br>lead<br>Externally contain lead lined<br>full-length drapes to entirely<br>contain the scattered<br>radiation from all angles<br>Operator can stand at side of<br>machine.<br>Wearing of protective<br>shielding is optional. | No<br>requires to be installed in a<br>shielded room with door light<br>and interlock | Same as the primary<br>predicate device |
| CARE 2D Camera | integrated into the gantry<br>front to observe the patient<br>during examination | N/A | integrated into the gantry<br>front and back to observe the<br>patient during examination | Equivalent<br>In software version<br>syngo CT VB10, a 2D |
| Hardware (HW)<br>property | Subject device<br>SOMATOM On.site<br>SOMARIS/10 syngo CT VB10 | Primary predicate device<br>SOMATOM On. scanners<br>SOMARIS/10 syngo CT VA35<br>(K193277) | Secondary predicate device<br>SOMATOM go.Up<br>SOMARIS/10 syngo CT VB10<br>(K233650) | Assessment of the<br>substantial<br>equivalency (SE) |
| | | | | Camera hardware is<br>integrated into the<br>gantry front. This<br>allows to observe the<br>patient from the front<br>of the system when<br>the front radiation<br>shield was closed. The<br>bore light illuminates<br>the bore so the<br>patient's face can be<br>seen on the 2D Camera<br>images. |
| Scanner Mobility | | | | |
| Mobile/ Fixed | Mobile/ fixed<br>• SOMATOM On.site for<br>Intensive Care Unit (ICU):<br>Mobile CT scanner affixed to<br>an optional motorized trolley<br>for use in hospital trauma<br>situations.<br>• SOMATOM On.site for<br>Mobile Stroke Unit (MSU):<br>Fixed CT Scanner that can be<br>mounted to the floor of a | Mobile/ fixed<br>• SOMATOM On.site:<br>Mobile CT scanner affixed to<br>an optional motorized trolley<br>for use in hospital trauma<br>situations.<br>• SOMATOM On.scene:<br>Fixed CT Scanner that can be<br>mounted to the floor of a<br>diagnostic room or vehicle,<br>e.g. Mobile Stroke Unit (MSU) | fixed | Same as the primary<br>predicate device<br>Note: Rebranding of<br>the CT system as<br>SOMATOM On.site<br>only with two variants,<br>ICU and MSU;<br>mobile/fixed method is<br>unchanged compared |
| Hardware (HW)<br>property | Subject device<br>SOMATOM On.site<br>SOMARIS/10 syngo CT VB10 | Primary predicate device<br>SOMATOM On. scanners<br>SOMARIS/10 syngo CT VA35<br>(K193277)…