SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO

K192061 · Siemens Medical Solutions USA, Inc. · JAK · Nov 21, 2019 · Radiology

Device Facts

• Record ID: K192061
• Device Name: SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Nov 21, 2019
• 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 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. * * 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

SOMATOM go.Platform (go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro) are whole-body X-ray CT scanners using fan-beam geometry and rotating tube-detector systems. Input: X-ray transmission data. Output: DICOM-format cross-sectional images. Operated by trained staff/physicians in clinical settings. Optional Scan&GO mobile workflow allows remote scan planning/control via wireless tablet. System features include iterative reconstruction, tin filtration, and advanced post-processing (Recon&GO). Used for diagnosis, treatment planning, and low-dose lung cancer screening. Benefits include optimized workflow, reduced radiation dose, and enhanced patient positioning via 3D camera and laser systems. Healthcare providers use images for clinical decision-making in radiology, oncology, and radiotherapy.

Clinical Evidence

Bench testing only. No clinical trials performed. Performance validated via phantom testing, integration/functional testing, and software verification. Features like DirectDensity, Spectral Recon, and Check&GO were validated against established algorithms or manual ground truth annotations. Clinical literature (National Lung Screening Trial) cited to support lung cancer screening indication.

Technological Characteristics

Whole-body CT scanner; fan-beam geometry; rotating tube-detector (Chronon/Athlon/Vectron tubes; Stellar detectors). Materials: standard medical-grade components. Energy: X-ray. Connectivity: DICOM, wireless tablet (Scan&GO). Software: SOMARIS/10 syngo CT VA30 (Windows-based). Features: Tin/Split filters, iterative reconstruction (SAFIRE, iMAR), DirectDensity, HD FoV 4.0. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for patients requiring cross-sectional imaging via CT reconstruction for diagnosis, treatment preparation, and radiation therapy planning. 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.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, Scan&GO (K173632)
• SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence (K190578)

Reference Devices

• syngo.CT Dual Energy (K191468)
• syngo.CT Coronary Analysis (K173637)
• syngo.CT Vascular Analysis (K173637)
• syngo.CT LungCAD (K143196)
• syngo.via software version VB10 (K150843)
• syngo.CT Bone Reading (K123584)
• syngo.via RT Image Suite (K192065)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 21, 2019

Siemens Medical Solutions USA, Inc. % Alaine Medio Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K192061

Trade/Device Name: SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro and Scan&GO Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 22, 2019 Received: October 23, 2019

Dear Alaine Medio:

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 (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 located 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.

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 803) for

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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K192061

Device Name

SOMATOM Go Platform CT Scanners including: SOMATOM go.Now, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro

#### 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 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 .*

* 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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## *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]

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# Indications for Use

510(k) Number (if known) K192061

Device Name Scan & GO

Indications for Use (Describe)

The in-room scan application is a planning and information system the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.

The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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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# K192061

# 510(K) SUMMARY FOR SOMATOM GO. PLATFORM SCANNERS -SOFTWARE VERSION SOMARIS/10 syngo CT VA30

Submitted by: Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Date Prepared: November 14, 2019

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. 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 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

#### Contact Person:

Alaine Medio, RAC Regulatory Affairs Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 [phone] (work cell) [phone] FAX [e-mail]

# II. Device Name and Classification

| Product Name: | SOMATOM go.Now, SOMATOM go.Up,<br>SOMATOM go.All, SOMATOM go.Top,<br>SOMATOM go.Sim, SOMATOM go.Open Pro |
|---------------|----------------------------------------------------------------------------------------------------------|
| Trade Name: | SOMATOM go.Now, SOMATOM go.Up,<br>SOMATOM go.All, SOMATOM go.Top,<br>SOMATOM go.Sim, SOMATOM go.Open Pro |

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| Classification Name: | Computed Tomography X-ray System |
|--------------------------------|---------------------------------------------|
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Name: | Scan&GO |
| Propriety Trade Name: | Scan&GO |
| Classification Name: | Computed Tomography X-ray System |
| Secondary Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Secondary CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | JAK |
| Secondary Product Code: | LLZ |
| III. Predicate Device | |

Primary Predicate Device: Trade Name:

510(k) Number: Clearance Date: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: Recall Information:

SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, Scan&GO K173632 April 13, 2018 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK All predicate device recalls have been considered in the subject device design.

Note: K173632 was a bundle submission with various Siemens SOMATOM go.Platform CT Scanner Systems, including SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top and Scan&GO software. In this submission, the predicate devices SOMATOM go.Top and Scan&GO are applicable, to demonstrate substantial equivalence of technological characteristics.

| Predicate Device: | |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM<br>Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus,<br>SOMATOM Definition AS/AS+, SOMATOM Confidence |
| 510(k) Number: | K190578 |
| Clearance Date: | June 27, 2019 |
| 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: | There are currently no recalls for this device |

Note: K190578 was a bundle submission with various Siemens SOMATOM CT Scanner Systems. In this Submission, the predicate devices SOMATOM Force and SOMATOM Edge Plus are applicable, to demonstrate substantial equivalence of technological characteristics.

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# IV. Device Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VA30 for Siemens SOMATOM Computed Tomography (CT) Scanner Systems with mobile workflow options.

## SOMATOM go. Platform is comprised of the following 6 CT scanners and optional mobile workflow:

- SOMATOM go.Up
- SOMATOM go.Now
- SOMATOM go.Top ●
- . SOMATOM go.All
- . SOMATOM go.Sim
- . SOMATOM go.Open Pro
- . Scan&GO Mobile Medical Application (optional mobile workflow component)

The subject device SOMATOM go.Platform with SOMARIS/10 syngo CT VA30 are Computed Tomography Xray Systems which feature one continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go.Platform with Software SOMARIS/10 syngo CT VA30 produces CT 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.

The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the SOMATOM go.Platform CT scanners. Scan&GO can be operated on a Siemens provided tablet or a commercially available tablet that meets certain minimum technical requirements. It allows users to work in the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet that meets certain minimum requirements:

- Selection of patients O
- Selection of pre-defined protocols O
- Scan parameter display O
- Patient table position display and gantry tilt parameter display O
- o Tools and instruction message area,
- Patient table position planning area o
- Physiological data display o
- Patient data display (e.g. date of birth, name) o
- Display of acquired topogram and tomogram images O
- Finalization of exam (close patient) O
- O Mobile Organizer,
- Patient Instruction Language ("API languages") O
- Control function for RTP Laser systems O
- O Control of mood light functions
- predefined workflow associated question/answer dialog O

NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.

The software version for the SOMATOM go.Platform, syngo CT VA30 (SOMARIS/10 syngo CT VA30), is a command-based program used for patient management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform SOMARIS/10 syngo CT VA30 is designed to provide a plugin interface to support the optional Scan&GO mobile workflow as well as integrate potential advanced post processing tasks, tools, or extendable functionalities. Software version syngo CT VA30 (SOMARIS/10 syngo CT VA30) is an update to software version syngo CT VA20A (SOMARIS/10 syngo CT VA20) which was cleared for the primary predicate devices in K173632, and supports the same plugin interfaces for the optional Scan&GO mobile workflow and integration of post-processing tasks as the predicate devices.

The SOMATOM go.Platform will support the following modifications/further developments in comparison to the predicate devices:

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#### 1) New/Modified Hardware

- Table S01: Overview of Hardware modifications ●
#### Software version SOMARIS/10 syngo CT VA30 2)

- Table S02: Overview Software modifications of SOMATOM go.Platform with syngo CT VA30 ●
The configuration table and comparison table use the following Terms to describe various technological characteristics in comparison to the predicate device 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 the subject device |
| Modified | This feature is modified from the previously cleared version |
| Unmodified | This feature remains unchanged from the predicate device |
| Enabled | This feature is currently supported by other cleared Siemens CT systems. This feature will be supported for the subject device with software version SOMARIS/10 syngo CT VA30 and the feature is unmodified from the cleared version. |

Table S01: Overview of Hardware Modifications in comparison to the corresponding SOMATOM go.Platform predicate devices

| # | hardware properties | Subject Devices<br>SOMATOM go.Now | Subject Devices<br>SOMATOM go.Up | Subject Devices<br>SOMATOM go.All | Subject Devices<br>SOMATOM go.Top | Subject Devices<br>SOMATOM go.Sim | Subject Devices<br>SOMATOM go.Open Pro |
|---|-----------------------------------------------------------------------------|-----------------------------------|----------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|----------------------------------------|
| 1 | Patient<br>Observation<br>Camera | Unmodified | Unmodified | Unmodified | Unmodified | Modified | Modified |
| 2 | Moodlight | Unmodified | Unmodified | Unmodified | Unmodified | Modified | Modified |
| 3 | Various Tablet<br>Configuration | Modified | Modified | Modified | Modified | Modified | Modified |
| 4 | High Power 70 /<br>High Power 80 | Unmodified | Unmodified | Unmodified | Unmodified | Enabled | Enabled |
| 5 | Adaptive Dose<br>Shield | N/A | N/A | N/A | Enabled | N/A | Enabled |
| 6 | Tin Filter | Unmodified | Unmodified | Unmodified | Unmodified | Enabled | Enabled |
| 7 | Split Filter | N/A | N/A | N/A | Unmodified | N/A | Enabled |
| 8 | Integrated Patient<br>Marking –<br>Direct Laser | N/A | N/A | N/A | N/A | New | New |
| 9 | Other hardware<br>modifications<br>(e.g. new large<br>bore size and<br>FoV) | N/A | N/A | N/A | N/A | Modified | Modified |

Table SV2: Overview Software modifications of SOMATOM go.Platform with syngo CT VA30 in comparison to the corresponding SOMATOM go.Platform predicate devices

| | SOMATOM CT<br>System Scanner<br>with<br>SOMARIS/10<br>syngo CT VA30 | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices |
|---|---------------------------------------------------------------------|--------------------|--------------------|--------------------|--------------------|--------------------|------------------------|--------------------|
| | Software<br>properties | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.All | SOMATOM<br>go.Top | SOMATOM<br>go.Sim | SOMATOM<br>go.Open Pro | Scan&GO |
| 1 | MPPS | Enabled | Enabled | Enabled | Enabled | Enabled | Enabled | N/A |
| 2 | Flex Dose Profile | Modified | Modified | Modified | Modified | Modified | Modified | N/A |
| 3 | Flex 4D Spiral | N/A | N/A | Modified | Modified | Modified | Modified | N/A |
| 4 | DirectDensity™ | Enabled | Enabled | Enabled | Enabled | Enabled | Enabled | N/A |
| 5 | Scan&GO -<br>Mobile workflow | Modified | Modified | Modified | Modified | Modified | Modified | Modified |
| 6 | CT View&GO -<br>Advanced tools | Modified | Modified | Modified | Modified | Modified | Modified | N/A |

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| | SOMATOM CT<br>System Scanner<br>with<br>SOMARIS/10<br>syngo CT VA30 | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices |
|----|---------------------------------------------------------------------|--------------------|--------------------|--------------------|--------------------|--------------------|------------------------|--------------------|
| | Software<br>properties | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.All | SOMATOM<br>go.Top | SOMATOM<br>go.Sim | SOMATOM<br>go.Open Pro | Scan&GO |
| 7 | Check&GO - Metal<br>Detection | New | New | New | New | New | New | New |
| 8 | CARE Contrast III<br>and Contrast media<br>protocol | Modified | Modified | Modified | Modified | Modified | Modified | N/A |
| 9 | CARE kV | N/A | N/A | Modified | Modified | Modified | Modified | N/A |
| 10 | kV and Filter<br>independent<br>CaScore<br>(Artificial120) | N/A | Enabled | Enabled | Enabled | Enabled | Enabled | N/A |
| 11 | Recon&GO -<br>Advanced<br>Reconstruction | Modified | Modified | Modified | Modified | Modified | Modified | N/A |
| 12 | Recon&GO - Post-<br>Processing plug in<br>functions | Modified | Modified | Modified | Modified | Modified | Modified | N/A |
| 13 | TwinBeam Dual<br>Energy | N/A | N/A | N/A | Modified | N/A | Modified | N/A |
| 14 | TwinSpiral Dual<br>Energy / TwinSpiral<br>DE | Modified | Modified | Modified | Modified | Modified | Modified | N/A |
| 15 | FAST Planning.<br>FAST Window | Modified | Modified | Modified | Modified | Modified | Modified | N/A |
| 16 | HD FoV 4.0 | Enabled | Enabled | Enabled | Enabled | Enabled | Enabled | N/A |
| 17 | Imaging - Exam<br>workflow | New | New | New | New | New | New | New |
| 18 | Imaging - Cardio<br>BestPhase | N/A | Enabled | Enabled | Enabled | Enabled | Enabled | N/A |
| 19 | Multistudy | Modified | Modified | Modified | Modified | Modified | Modified | N/A |
| 20 | Multiphase | N/A | N/A | Modified | Modified | Modified | Modified | N/A |
| 21 | Respiratory Motion<br>Management | Enabled | Enabled | Enabled | Enabled | Enabled | Enabled | N/A |
| 22 | Patient Marking -<br>Direct Laser<br>Steering | New | New | New | New | New | New | New |
| 23 | Direct i4D | N/A | N/A | N/A | N/A | N/A | New | N/A |

A comparison of these modifications with respect to the predicate devices is provided in the "Comparison of Technological Characteristics with the Predicate Device" section below. Software version SOMARIS/10 syngo CT VA30 will be offered as an optional upgrade for the existing SOMATOM CT go.Platform Systems.

# 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 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. *

*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.

# Scan&GO:

The in-room scan application is a planning and information system designed to perform the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.

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The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.

# VI. Comparison of Technological Characteristics with the Predicate Device

The SOMATOM go. Platform scanners and optional Scan&GO mobile workflow provide the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software and hardware components of the SOMATOM go. Platform have been modified or improved in comparison to the predicate devices to support enhanced device functionality. The hardware components of the subject devices have been modified to support mobile workflow with multiple tablet configuration, a 3D Camera workflow for patient positioning, a larger bore size and an integrated laser system for patient marking to support treatment planning workflows.

Software version SOMARIS/10 syngo CT VA30 supports software features that are designed as a Software Platform update including extended functionalities and GO technologies which provide interfaces to directly access optional post processing applications and are designed to enhance the user workflow.

The intended use and fundamental scientific technology for the SOMATOM go.Uo. SOMATOM go.All, SOMATOM go.SOMATOM go.Sim and SOMATOM go.Open Pro remains unchanged from the predicate devices.

## At a high level, the subject and predicate devices are based on the following same 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 methods ●
- Workplaces Support of workplaces that include reconstruction and image evaluation software ●
- . Patient table
- Patient table foot switch for movement
- Tin filtration technology
- Chronon, Athlon or Vectron X-ray Tube
- Stellar detector technology
- . Maximum power Generator
- High Power 70, High Power 80 (High mA@low kV)
- . Iterative Reconstruction Methods
- . Mobile Medical application Software functionality (Scan&GO)
- Mobile workflow (Tablet)
- . Scanner display and control functionality
- Remote Scan Control
- Support of Intervention Workflow - Guide&GO
- Optional Injector Arm
- Long scan range
- DirectDensity™ Reconstruction, which provides CT images with an HU-like scaling that is nearly . proportional to relative electron density or relative mass density
- . Respiratory Scan - Functions

#### The following technological differences exist between the subject device SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top and the corresponding primary predicate devices of the SOMATOM go. Platform (K173632) and the predicate device SOMATOM Edge Plus (K190578):

- Software version SOMARIS/10 syngo CT VA30 ●
- Support of additional cybersecurity features
- Multiple tablet configuration for enhanced mobile workflow and control functionality
- . Additional options for Inline and GO technologies
- CT protocol workflow enhanced functionality for advanced examination including parameter for scan ● protocol and contrast media.
- Interface to RTP Lasers (e.g. LAP, Siemens Direct Laser)

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The following technological differences exist between the subject device SOMATOM go.Sim and SOMATOM go. Open Pro and the predicate device SOMATOM go.Top (K173632) and the predicate device SOMATOM Edge Plus (K190578):

- . Software version SOMARIS/10 syngo CT VA30
- Support of additional cybersecurity features
- Multiple tablet configuration for enhanced mobile workflow and control functionality
- . Additional options for Inline and GO technologies
- CT protocol workflow enhanced functionality for advanced examination including parameter for scan protocol and contrast media.
- . Interface to RTP Lasers for Direct Laser Steering (e.g. in combination with 3rd party LAP laser system or Siemens integrated Direct Laser system)
- . Optional integrated Laser System for patient marking
- . CT gantry hardware supporting large bore size and 60 cm scan field-of-view

#### The following technological differences exist between the subject device Scan&GO and the primary predicate device Scan&GO (K173632):

- Software version SOMARIS/10 syngo CT VA30
- Advanced workflow (including option for Direct Laser Steering e.g. for LAP or Siemens Direct Laser)
- . Optional hardware support for multiple tablet configuration

A summary of the differences between the subject device CT scanner configurations is provided as Table S03 and Table S04 below.

The tabular summary of the comparable hardware properties between the subject devices with software version SOMARIS/10 syngo CT VA30 and the predicate devices are listed in Table S03 below (modifications are in gray shaded sections).

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| | <i>Table S03:</i> SOMATOM go.Platform comparable hardware properties<br>SOMATOM go.Platform - Device Comparison (Single Source Systems) | | | | | | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-------------------------|-------------------------------------------|------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------|
| Hardware<br>Property | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.All | SOMATOM<br>go.Top | SOMATOM<br>go.Sim | SOMATOM<br>go.Open Pro | Primary<br>Prediacte<br>Device<br>SOMATOM<br>go.Top<br>(K173632) |
| Scanner | whole body X-ray computed tomography scanner | | | | | | |
| Generator<br>max. power | 32 kW | 32 kW | 75 kW | 75 kW | 75 kW | 75 kW | 75 kW |
| Detector<br>technology | Stellar | Stellar | Stellar | Stellar | Stellar | Stellar | Stellar |
| Detector<br>volumen<br>coverage | 11.2 mm | 22.4 mm | 22.4 mm | 38.4 mm | 19.2 mm | 38.4 mm | 38.4 mm |
| Detector<br>physical rows | 16 | 32 | 32 | 64 | 32 | 64 | 64 |
| Detector<br>slice width | 0.7 mm | 0.7 mm | 0.7 mm | 0.6 mm | 0.6 mm | 0.6 mm | 0.6 mm |
| Detector<br>DAS channel<br>No. | 768 | 768 | 768 | 840 | 920 | 920 | 840 |
| Detector<br>image slices | 32 | 64 | 64 | 128 | 64 | 128 | 128 |
| Tube<br>Technologie | Chronon | Chronon | Athlon | Athlon | Athlon | Athlon | Athlon |
| Tube<br>kV steps | | (in 20kV steps)<br>80 kV to 130kV | | | (in 10kV steps)<br>70 kV to 140 kV | | |
| Tube<br>max. current | 400 mA | 400 mA | 825 mA | 825 mA | 825 mA | 825 mA | 825 mA |
| Tube<br>tube focus | 0.8 x 0.4<br>0.8 x 0.7 | 0.8 x 0.4<br>0.8 x 0.7 | 1.0 x 1.2<br>0.8 x 0.8 | 1.0 x 1.2<br>0.8 x 0.8 | 1.0 x 1.2<br>0.8 x 0.8 | 1.0 x 1.2<br>0.8 x 0.8 | 1.0 x 1.2<br>0.8 x 0.8 |
| Tube<br>heat capacity | 3.5 MHU | 3.5 MHU | 6 MHU | 6 MHU | 6 MHU | 6 MHU | 6 MHU |
| Gantry<br>bore size | 70 cm | 70 cm | 70 cm | 70 cm | 85 cm | 85 cm | 70 cm |
| Gantry<br>FoV | 50 cm | 50 cm | 50 cm | 50 cm | 60 cm | 60 cm | 50 cm |
| Gantry<br>rotation time<br>(sec) | 0.8, 1.0, 1.5 | | 0.33, 0.5, 1.0 | | 0.35, 0.5, 1.0 | | 0.33, 0.5, 1.0 |
| Gantry<br>Tilt [degrees] | N/A | +/-25 | +/-25 | +/-25 | +/-25 | +/-25 | +/-25 |
| Patient Table<br>type | Vector:<br>1.250 m<br>Vario 1 and<br>Vario RT:<br>1.600 m with<br>table<br>extension | Vario 1 (1.600 m, Vario 2 (2.000m and Vario<br>RT: 1.600 m with table extension | | | Vario 2 (2.000m and Vario<br>RT: 1.600 m with table<br>extension | | Vario 1<br>(1.600 m,<br>Vario 2<br>(2.000m and<br>Vario RT:<br>1.600 m with<br>table<br>extension |
| Max. Scan<br>length<br>Topogram | 1680 mm | 1680 mm<br>2080 mm | 1680 mm<br>2080 mm | 1680 mm<br>2080 mm | 1680 mm<br>2080 mm | 1680 mm<br>2080 mm | 1680 mm<br>2080 mm |
| Max. Scan<br>length<br>Image<br>acquisition | 1600 mm | 1600 mm,<br>2000 mm | 1600 mm,<br>2000 mm | 1600 mm,<br>2000 mm | 1600 mm,<br>2000 mm | 1600 mm,<br>2000 mm | 1600 mm,<br>2000 mm |
| Spectral<br>filtration<br>option | Tin Filter<br>supported | Tin Filter<br>supported | Tin Filter<br>supported | Combined<br>Split<br>Filter/Tin<br>Filter | Tin Filter<br>supported | Combined<br>Split<br>Filter/Tin<br>Filter | Combined<br>Split<br>Filter/Tin<br>Filter |
| High Power 70 | N/A | N/A | 825 mA<br>(@ 70 kV) | 825 mA<br>(@ 70 kV) | 825 mA<br>(@ 70 kV) | 825 mA<br>(@ 70 kV) | 825 mA<br>(@ 70 kV) |
| High Power 80 | N/A | N/A | 825 mA<br>(@ 70 kV) | 825 mA<br>(@ 70 kV) | 825 mA<br>(@ 70 kV) | 825 mA<br>(@ 70 kV) | 825 mA<br>(@ 70 kV) |

| Table S03: SOMATOM go.Platform comparable hardware properties |
|---------------------------------------------------------------|
|---------------------------------------------------------------|

The tabular summary of the comparable software properties between the subject devices with software version SOMARIS/10 syngo CT VA30 and the predicate devices are listed in Table S04 below (modifications are in gray shaded sections).

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| | Subject Device | Primary Predicate Device | Predicate Device |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SOMATOM go.Now,<br>● | SOMATOM go.Now,<br>● | SOMATOM Edge Plus |
| | SOMATOM go.Up,<br>● | SOMATOM go.Up,<br>● | |
| Properties<br>software | SOMATOM go.All,<br>● | SOMATOM go.All,<br>● | |
| | SOMATOM go.Top,<br>● | SOMATOM go.Top ● | |
| | SOMATOM go.Sim,<br>● | | |
| | SOMATOM go.Open Pro<br>(syngo CT VA30) | | |
| | | (K173632) | (K190578) |
| Operating<br>System | Windows based<br>SOMARIS/10 syngo CT VA30 | Windows based<br>SOMARIS/10 syngo CT VA20A | Windows based<br>SOMARIS/7 syngo CT VB20 |
| | syngo Acquisition Workplace<br>(AWP) | syngo Acquisition Workplace<br>(AWP) | syngo Acquisition Workplace<br>(AWP) |
| Acquisition<br>Workplace | syngo Viewing, syngo Filming<br>and syngo Archiving &<br>Networking | syngo Viewing, syngo Filming<br>and syngo Archiving &<br>Networking | syngo Viewing, syngo Filming<br>and syngo Archiving &<br>Networking |
| | Image Reconstruction | Image Reconstruction | Image Reconstruction |
| Stellar Detector | Stellar detector firmware<br>supported | Stellar detector firmware<br>supported | Stellar detector firmware<br>supported |
| Teamplay | Support teamplay Protocols | Support teamplay Protocols | Support teamplay Protocols |
| | Support of:<br>● Protocols for Radiation<br>Therapy Planning support<br>patient marking<br>● Protocols that allow scanning<br>with support of an external<br>respiratory gating system<br>(ANZAI, Varian RGSC)<br>● Protocol supporting contrast<br>bolus-triggered data<br>acquisition<br>● Contrast media protocols<br>● Pediatric Protocols<br>● Flex Dose Profile<br>● TwinBeam DE<br>● TwinSpiral DE<br>● Flex 4D Spiral | Support of:<br>● Protocols for Radiation<br>Therapy Planning<br>● Protocol supporting contrast<br>bolus-triggered data<br>acquisition<br>● Pediatric Protocols | Support of :<br>● Protocols for Radiation<br>Therapy Planning<br>● Protocols for Radiation<br>Therapy Planning<br>● Protocols that allow<br>triggering of breath hold<br>scanning from external<br>device.<br>● Protocol supporting contrast<br>bolus-triggered data<br>acquisition<br>● Pediatric Protocols<br>● Adaptive Dose Area<br>● DualSource DE<br>● Adaptive 4D Spiral |
| Protocols | | | |
| | | | |
| | | | |
| | enabled via software interface | enabled via software interface | enabled via stand-alone<br>workplace software installation |
| post-processing<br>methods<br>(syngo CT<br>VA30 enable a<br>subset of<br>methods on the<br>scanner software<br>installation –<br>only applicable<br>for previously<br>cleared<br>syngo.CT<br>applications) | Recon&GO - Inline Results<br>varies methods contained in the<br>available applications<br>syngo.CT Coronary Analysis<br>syngo.CT Vascular Analysis<br>syngo.CT Dual Energy<br>syngo.CT Bone Reading<br>syngo.via RT Image Suite<br>Note 1: Detailed information<br>about the subset of enabled<br>syngo.CT functionalities is listed<br>below. | Recon&GO - Inline Results<br>varies methods contained in the<br>available applications<br>syngo.CT Vascular Analysis,<br>syngo.CT Bone Reading,<br>syngo.…