SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO

K200524 · Siemens Medical Solutions USA, Inc. · JAK · Apr 1, 2020 · Radiology

Device Facts

• Record ID: K200524
• Device Name: SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Apr 1, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

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. 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.

Device Story

Computed tomography (CT) scanner system using continuously rotating tube-detector technology and fan-beam geometry to generate cross-sectional images. Input: X-ray transmission data. Output: DICOM-format CT images. Operated by trained staff/physicians in clinical settings. Includes 'Scan&GO' mobile workflow application running on tablets/PCs for remote scan planning, patient positioning, and protocol selection; does not store images or trigger radiation. Features 'Recon&GO' for inline post-processing (e.g., lung CAD, bone removal, cardiac analysis). Used for diagnosis, treatment planning (e.g., radiotherapy, surgery), and lung cancer screening. Benefits include optimized workflow, fast patient positioning via 3D camera, and automated image reconstruction to aid clinical decision-making.

Clinical Evidence

Bench testing only. No clinical trials performed for this submission. Validation included phantom tests, system integration, functional verification, and image quality evaluation. Supportive literature (National Lung Screening Trial, N Engl J Med 2011) cited for lung cancer screening indication. FAST 3D camera accuracy validated against predicate. Contrast protocols verified against drug labeling.

Technological Characteristics

Whole-body CT scanner; fan-beam principle; rotating tube-detector. Materials: Stellar detector technology, Chronon/Athlon/Vectron X-ray tubes. Connectivity: Networked (DICOM). Software: SOMARIS/10 syngo CT VA30 (update). Features: Iterative reconstruction (SAFIRE, iMAR), Tin filtration, DirectDensity reconstruction. Scan&GO: Wireless tablet/PC interface (IEEE 802.11h). Standards: IEC 60601-2-44, IEC 60601-1-2, DICOM PS 3.1-3.20.

Indications for Use

Indicated for patients requiring cross-sectional imaging via CT reconstruction for diagnostic aid, 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 X.cite (K191891)
• Scan&GO (K191891)
• SOMATOM go.Top (K192061)
• Scan&GO (K192061)

Reference Devices

• syngo.CT Coronary Analysis (K173637)
• syngo.CT Vascular Analysis (K173637)
• syngo.CT LungCAD (K143196)
• syngo.via (K191040)
• syngo.CT Bone Reading (K123584)
• syngo.via RT Image Suite (K192065)
• syngo.CT CaScoring (K192763)
• syngo.via RT Image Suite (K192065)

Submission Summary (Full Text)

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April 1, 2020

Image /page/0/Picture/1 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 in blue, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

Siemens Medical Solutions USA, Inc. % Ms. Tabitha Estes Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K200524

Trade/Device Name: SOMATOM X.cite and SOMATOM go.Platform CT Scanners including: SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go. Open Pro, Scan&GO Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, LLZ Dated: February 28, 2020 Received: March 2, 2020

Dear Ms. Estes:

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 medical devices and radiation-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)

K200524

#### Device Name

SOMATOM X.cite and SOMATOM Go Platform CT Scanners including; SOMATOM go.Now, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro , Scan&Go

#### 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.

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 PRAStaff(@fda.hhs.gov

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# Indications for Use

510(k) Number (if known)

K200524

Device Name Scan & Go

Indications for Use (Describe)

This 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) | |
|--------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subnart D) | Over-The-Counter Use (21 CFR 801 Subnart 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 PRAStaff(@fda.hhs.gov

"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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# 510(K) SUMMARY

FOR

# SOMATOM GO. PLATFORM & SOMATOM X.CITE CT SCANNER SYSTEMS - Software version SOMARIS/10 syngo CT VA30 (Update)

Submitted by: Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Date Prepared: February 28, 2020

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.

### l. 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:

Tabitha Estes Requlatory Affairs Siemens Medical Solutions USA, Inc. [phone] (work cell) [phone] FAX [e-mail]

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# II. Device Name and Classification

| Product Name: | SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite |
|-----------------------|--------------------------------------------------------------------------------------------------------------------|
| Trade Name: | SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |

| 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: | SOMATOM X.cite, Scan&GO |
|-----------------------|------------------------------------------------|
| 510(k) Number: | K191891 |
| Clearance Date: | November 06, 2019 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Requlation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | There are currently no recalls for this device |

# Reference Device:

Trade Name:

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

| Scan&GO | |
|-----------------------|------------------------------------------------------------------------------------|
| 510(k) Number: | K192061 |
| Clearance Date: | November 21, 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: | All predicate device recalls have been considered in the subject device<br>design. |

Note: K192061 was a bundle submission with various Siemens CT Scanner Systems, including SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro 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.

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# IV. Device Description

Siemens intends to update software version, SOMARIS/10 syngo CT VA30 (Update) for Siemens SOMATOM Computed Tomography (CT) Scanner Systems with mobile workflow and 3D Camera options.

This update includes support of additional hardware for the go. platform and includes reuse of optional postprocessing applications for Recon&GO for all scanners subject of this submission.

# The SOMATOM CT Scanner Systems that support the same software platform update include:

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

The subject device SOMATOM go. platform and SOMATOM X.cite with SOMARIS/10 syngo CT VA30 (update) are Computed Tomography X-ray Systems which feature one continuously rotating tubedetector system and function according to the fan beam principle. The SOMATOM go. platform and SOMATOM X.cite with software SOMARIS/10 syngo CT VA30 (update) produces CT images in DICOM format. These images can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors. These images 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 X.cite and SOMATOM go. platform CT scanners. Scan&GO can be operated on a Siemens provided tablet or personal computer that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet or personal computer with WiFi connection 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
- Tools and instruction message area, O
- 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
- Mobile Organizer, O
- Patient Instruction Language ("API languages") O
- Control function for RTP Laser systems O
- Control of moodlight functions O
- 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 SQMATOM go, platform and SOMATOM X.cite, syngo CT VA30 (update) (SOMARIS/10 syngo CT VA30 (update)), 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 syngo CT VA30 (update) is designed to support a software plugin interface to reuse a subset of stand-alone, cleared processing software

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applications. Software update version syngo CT VA30 (update) (SOMARIS/10 syngo CT VA30 (update)) shall support additional software features and hardware options, which was cleared for the primary predicate device in K191891, 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 and SOMATOM X.cite will support the following modifications/further developments in comparison to the predicate devices:

### 1) New/Modified Hardware

- Table S5-01: Overview of Hardware modifications
### 2) Software version SOMARIS/10 syngo CT VA30 (update)

- Table S5-02: Overview Software modifications ●
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 or<br>cleared Siemens stand alone software applications. This feature will be supported<br>for the subject device with software version SOMARIS/10 syngo CT VA30<br>(update) and is substantial equivalent from it's cleared version. |

Table S5-01: Overview of Hardware Modifications in comparison to the corresponding predicate devices

| | CT Scanner Systems with<br>SOMARIS/10 syngo CT<br>VA30 (update) | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices | Subject<br>Devices |
|---|-----------------------------------------------------------------|--------------------|--------------------|------------------------------|------------------------------------|--------------------|--------------------|
| | # hardware properties | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.All/<br>go.Top | SOMATOM<br>go.Sim /<br>go.Open Pro | SOMATOM<br>X.cite | Scan&GO |
| 1 | 3D Camera | N/A | Enabled | Enabled | Enabled | Unmodified | N/A |
| 2 | Optional hardware for<br>Scan&GO to support inroom<br>monitor. | Unmodified | Unmodified | Unmodified | Unmodified | Unmodified | Modified |

Table S5-02: Overview Software modifications of SOMATOM go. platform and SOMATOM X.cite with syngo CT VA30 (update) in comparison to the corresponding predicate devices

| | CT Scanner Systems with<br>SOMARIS/10 syngo CT<br>VA30 (update) | Subject Devices | Subject Devices | Subject Devices | Subject Devices | Subject Devices | Subject Devices |
|---|-----------------------------------------------------------------------------|-------------------|------------------|------------------------------|-----------------------------------|-------------------|-----------------|
| | Software properties | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.All/<br>go.Top | SOMATOM<br>go.Sim/<br>go.Open Pro | SOMATOM<br>X.cite | Scan&GO |
| 1 | Recon&GO - Inline Results<br>● LungCAD<br>● Anatomical<br>Ranges | Unmodified | Unmodified | Unmodified | Enabled | Enabled | N/A |
| 2 | Recon&GO - Inline Results<br>● RT Automatic<br>Contouring<br>(DirectORGANS) | N/A | N/A | N/A | Enabled | Enabled | N/A |
| 3 | Recon&GO - Inline Results<br>● CaScoring | N/A | N/A | Enabled | Enabled | Enabled | N/A |
| 4 | Contrast media protocol<br>(additional protocol for<br>coronary CTA) | N/A | N/A | Modified | Modified | Modified | N/A |
| 5 | FAST Integrated Workflow<br>(including FAST 3D<br>Camera) | N/A | Enabled | Enabled | Enabled | Unmodified | Unmodified |

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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 (update) will be offered as an optional upgrade for the existing SOMATOM CT go.platform Systems and SOMATOM X.cite.

# 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.

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 subject devices (SOMATOM go. platform scanners, SOMATOM X.cite scanners and optional Scan&GO mobile workflow software application) provide the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software features of the SOMATOM go. platform and SOMATOM X.cite have been modified in comparison to the predicate devices to support additional hardware options and to reuse a subset of cleared postprocessing algorithms. The subject devices CT scanner hardware is unmodified as cleared with K192061 and K191891. The hardware modification in combination with the subject devices support a mobile workflow option with personal computer configuration and 3D Camera workflow for patient positioning.

Software version SOMARIS/10 syngo CT VA30 (update) supports software features that are designed as a software platform update including Recon&GO Inline Result technologies which provide interfaces to directly access a subset of optional post processing applications and are designed to enhance the user workflow.

The intended use and fundamental scientific technology for the SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro and SOMATOM X.cite remains unchanged from the predicate devices.

### At a high level, the subject and predicate devices are based on the following same technoloqical 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

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- 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)
- Support of interfaces to access 3D Camera operation for fast patient positioning workflow ●
- . 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, SOMATOM go.Sim, SOMATOM go.Open Pro. SOMATOM X.cite and the primary predicate device SOMATOM X.cite cleared in K191891 and the predicate device SOMATOM go.Top cleared in K192061:

- Software version SOMARIS/10 syngo CT VA30 (update) (enable additional . hardware/software options)
- Mobile workflow include Scan&GO installation on personal computer ●
- Various additional post processing software plug-in options for Recon&GO Inline Results ●
- Optional advanced CARE examination including new protocol for contrast media ●

### The following technological differences exist between the subject device Scan&GO and the predicate device Scan&GO cleared in K191891:

- . Optional hardware support for personal computer configuration
A summary of the differences between the subject device CT scanner configurations is provided as Table S5-03 and Table S5-04 below.

The tabular summary of the comparable hardware properties between the subject devices SOMATOM go. platform CT Scanner Systems with software version SOMARIS/10 syngo CT VA30 (update) and the predicate device SOMATOM X.cite are listed in Table S5-03 below (modifications are in gray shaded sections).

There are no hardware changes for subject device SOMATOM X.cite in comparison to the predicate device SOMATOM X.cite cleared in K191891.

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| Hardware<br>Property | SOMATOM go. platform - Device Comparison (Single Source Systems)<br>Subject Device | | | | | | Predicate<br>SOMATOM<br>X.cite<br>K191891 |
|---------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------------------------------|-------------------------------------------|------------------------------------------------------------------------------------|
| | SOMATOM<br>go.Now | SOMATOM<br>go.Up | SOMATOM<br>go.All | SOMATOM<br>go.Top | SOMATOM<br>go.Sim | SOMATOM<br>go.Open<br>Pro | |
| Scanner<br>Generator<br>max. power | 32 kW | 32 kW | 75 kW | 75 kW | 75 kW | 75 kW | 105 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 | Vectron |
| Tube<br>kV steps | | (in 20kV steps)<br>80 kV to 130kV | (in 10kV steps)<br>70 kV to 140 kV | | | | (in 10kV<br>steps)<br>70 kV to<br>150 kV |
| Tube<br>max. current | 400 mA | 400 mA | 825 mA | 825 mA | 825 mA | 825 mA | 1200 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 | 0.6 x 0.7<br>0.8 x 1.1 |
| Tube<br>heat capacity | 3.5 MHU | 3.5 MHU | 6 MHU | 6 MHU | 6 MHU | 6 MHU | >30 MHU |
| Gantry<br>bore size | 70 cm | 70 cm | 70 cm | 70 cm | 85 cm | 85 cm | 82 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 | 0.8, 1.0, 1.5 | 0.33, 0.5, 1.0 | 0.33, 0.5, 1.0 | 0.35, 0.5, 1.0 | 0.35, 0.5, 1.0 | 0.3, 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<br>with table<br>extension | | Vario 1 (1.600 m, Vario 2 (2.000m and<br>Vario RT: 1.600 m with table extension | | Vario 2 (2.000m and<br>Vario RT: 1.600 m with<br>table extension | | Vario RT:<br>1.600 m,<br>Vario 2:<br>2.000 m |
| 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 Filter /<br>Tin Filter<br>supported,<br>plus extra<br>Tin Filter |
| 3D Camera<br>for patient<br>positioning | N/A | | | supported | | | supported |
| High Power<br>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) | 1200 mA<br>(@ 70 kV) |
| High Power<br>80 | N/A | N/A | 825 mA<br>(@ 80 kV) | 825 mA<br>(@ 80 kV) | 825 mA<br>(@ 80 kV) | 825 mA<br>(@ 80 kV) | 1200 mA<br>(@ 80 kV) |

#### Table S5-03: SOMATOM go. platform comparable hardware properties

{11}------------------------------------------------

The tabular summary of the comparable software properties between the subject devices with software version SOMARIS/10 syngo CT VA30 (update) and the predicate devices are listed in Table S5-04 below (modifications are in gray shaded sections).

| | Subject Device | Predicate Device | Predicate Device |
|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SOMATOM go.Now,<br>SOMATOM go.Up,<br>SOMATOM go.All,<br>SOMATOM go.Top,<br>SOMATOM go.Sim,<br>SOMATOM go.Open Pro,<br>SOMATOM X.cite<br>(syngo CT VA30 (update)) | SOMATOM X.cite | SOMATOM go.Top |
| Properties<br>software | | | |
| | | (K191891) | (K192061) |
| Operating<br>System | Windows based<br>SOMARIS/10 syngo CT VA30 (update) (with additional<br>software options) | Windows based<br>SOMARIS/10 syngo CT VA30 (update) | Windows based<br>SOMARIS/10 syngo CT VA30 (update) |
| Acquisition<br>Workplace | syngo Acquisition Workplace (AWP) | syngo Acquisition Workplace (AWP) | syngo Acquisition Workplace (AWP) |
| | 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 : | Support of : | Support of : |
| | Protocols for Radiation<br>Therapy Planning support<br>patient markingProtocols that allow<br>scanning with support of<br>an external respiratory<br>gating system (ANZAI,<br>Varian RGSC)Protocol supporting<br>contrast bolus-triggered<br>data acquisitionContrast media protocols<br>(including coronary CTA)Pediatric ProtocolsFlex Dose ProfileTwinBeam DETwinSpiral DEFlex 4D Spiral | Protocols for Radiation<br>Therapy Planning support<br>patient markingProtocols that allow<br>scanning with support of<br>an external respiratory<br>gating system (ANZAI,<br>Varian RGSC)Protocol supporting<br>contrast bolus-triggered<br>data acquisitionContrast media protocolsPediatric ProtocolsFlex Dose ProfileTwinBeam DETwinSpiral DEFlex 4D Spiral | Protocols for Radiation<br>Therapy Planning support<br>patient markingProtocols that allow<br>scanning with support of<br>an external respiratory<br>gating system (ANZAI,<br>Varian RGSC)Protocol supporting<br>contrast bolus-triggered<br>data acquisitionContrast media protocolsPediatric ProtocolsFlex Dose ProfileTwinBeam DETwinSpiral DEFlex 4D Spiral |
| Protocols | | | |
| Recon&GO –<br>Advanced<br>Reconstruction. | Advanced reconstruction tools<br>supported:<br>- Spectral Recon (Dual Energy<br>Reconstruction)<br>- Inline Results DE SPP<br>(Spectral Post-Processing)<br>- Inline Results DE Ranges<br>(Parallel/Radial) / Inline DE | Advanced reconstruction tools<br>supported:<br>- Spectral Recon (Dual<br>Energy Reconstruction)<br>- Inline Results DE SPP<br>(Spectral Post-Processing)<br>- Inline Results DE Ranges<br>(Parallel/Radial) / Inline DE | Advanced reconstruction tools<br>provided to supported:<br>- Spectral Recon (Dual Energy<br>Reconstruction)<br>- Inline Results DE SPP<br>(Spectral Post-Processing)<br>- Inline Results DE Ranges<br>(Parallel/Radial) / Inline DE |
| Post-<br>Processing<br>plug in<br>functions<br>Enabled via<br>software | Heart Isolation,<br>Coronary Tree,<br>Vessel Ranges (LAD,<br>RCA, CX),<br>Cardiac Ranges | Heart Isolation,<br>Coronary Tree,<br>Vessel Ranges (LAD,<br>RCA, CX),<br>Cardiac Ranges | Heart Isolation,<br>Coronary Tree,<br>Vessel Ranges (LAD,<br>RCA, CX),<br>Cardiac Ranges |
| | Subject Device | Predicate Device | Predicate Device |
| | SOMATOM go.Now, | SOMATOM X.cite | SOMATOM go.Top |
| | SOMATOM go.Up, | | |
| Properties | SOMATOM go.All, | | |
| software | SOMATOM go.Top, | | |
| | SOMATOM go.Sim, | | |
| | SOMATOM go.Open Pro, | | |
| | SOMATOM X.cite | | |
| | (syngo CT VA30 (update)) | (K191891) | (K192061) |
| interface<br>Recon&GO -<br>Inline Results<br>varies methods<br>of cleared<br>software<br>applications | Vascular ranges (Aorta,<br>Carotis L Int., Carotic R<br>Int., Runoff L, Runoff R)<br>Inline Table removal<br>Inline Bone removal | Vascular ranges (Aorta,<br>Carotis L Int., Carotic R<br>Int., Runoff L, Runoff R)<br>Inline Table removal<br>Inline Bone removal | Vascular ranges (Aorta,<br>Carotis L Int., Carotic R<br>Int., Runoff L, Runoff R)<br>Inline Table removal<br>Inline Bone removal |
| | LungCAD<br>Anatomical ranges<br>(Parallel/Radial) | N/A | LungCAD<br>Anatomical ranges<br>(Parallel/Radial) |
| Note 1: Detailed<br>informations<br>about the subset<br>of enabled<br>syngo<br>functionalities<br>are listed below. | Radial Rib Ranges<br>Parallel Rib Ranges<br>Spine Range | Radial Rib Ranges<br>Parallel Rib Ranges<br>Spine Range | Radial Rib Ranges<br>Parallel Rib Ranges<br>Spine Range |
| | 3D and 4D image<br>visualization,<br>manipulation and manual<br>contouring tools for<br>preparation and response<br>assessment of<br>radiotherapy treatment. | 3D and 4D image<br>visualization,<br>manipulation and manual<br>contouring tools for<br>preparation and response<br>assessment of<br>radiotherapy treatment. | 3D and 4D image<br>visualization,<br>manipulation and manual<br>contouring tools for<br>preparation and response<br>assessment of<br>radiotherapy treatment. |
| | CaScoring<br>(Not supported by SOMATOM<br>go.Now and go.Up) | Automated CaScoring<br>function is supported via<br>stand alone software<br>application syngo.CT<br>CaScoring (K192763) | Automated CaScoring<br>function is supported via<br>stand alone software<br>application syngo.CT<br>CaScoring…