SOMATOM X.cite

K191891 · Siemens Medical Solutions USA, Inc. · JAK · Nov 6, 2019 · Radiology

Device Facts

• Record ID: K191891
• Device Name: SOMATOM X.cite
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Nov 6, 2019
• 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 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.

Device Story

SOMATOM X.cite is a single-source whole-body CT scanner using a continuously rotating tube-detector system (fan beam principle). Inputs: X-ray transmission data. Outputs: DICOM-format cross-sectional images. Operated by trained staff/physicians in clinical settings. Features 'Scan&GO' mobile workflow: wireless tablet interface for scan planning, protocol selection, and patient positioning (via 3D camera). Does not store images or trigger radiation. Software (SOMARIS/10 syngo CT VA30) manages patient data, scan control, and image reconstruction. Benefits: enhanced workflow efficiency, advanced reconstruction (Recon&GO), and patient positioning tools. Output used by clinicians for diagnosis, treatment planning, and radiation therapy (e.g., brachytherapy, proton therapy).

Clinical Evidence

Bench testing only. Includes phantom studies for image quality (HU accuracy, skin-line accuracy), verification of reconstruction algorithms (Spectral Recon, DirectDensity), and clinical use testing (internal/external simulations) to validate Scan&GO workflow. No prospective clinical trials conducted; relies on National Lung Screening Trial (NLST) literature for lung cancer screening indication.

Technological Characteristics

Single-source CT; Vectron X-ray tube; Stellar detector; 82cm bore; 105kW generator. Connectivity: DICOM, wireless tablet (IEEE 802.11h). Software: SOMARIS/10 syngo CT VA30 (Windows-based). Reconstruction: Iterative (ADMIRE, iMAR). Standards: IEC 60601-2-44, IEC 60601-1-2, NEMA 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 go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, 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 Bone Reading (K123584)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/10 description: The image shows 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. Underneath the FDA logo is the word "ADMINISTRATION".

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

Re: K191891

Trade/Device Name: SOMATOM X.cite Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 3, 2019 Received: October 4, 2019

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/cfpmp/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

November 6, 2019

{1}------------------------------------------------

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K191891

Device Name SOMATOM X.cite

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

"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."

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K191891

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) | |
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

## 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."

{4}------------------------------------------------

## K191891

## 510(K) SUMMARY FOR SOMATOM X.CITE - SOFTWARE VERSION SOMARIS/10 syngo CT VA30 Submitted by:

Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Date Prepared: July 12, 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:

Tabitha Estes Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Phone: [phone] Fax: [phone] Email: [e-mail]

### II. Device Name and Classification

| Product Name: | SOMATOM X.cite |
|-----------------------|----------------------------------|
| Trade Name: | 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 |

{5}------------------------------------------------

| 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 go.Up, SOMATOM go.Now, SOMATOM go.Top, |
| | SOMATOM go.All, Scan&GO |
| 510(k) Number: | K173632 |
| Clearance Date: | April 13, 2018 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |
| Recall Information: | All predicate device recalls have been considered in the subject device design. |

Note: K173632 was a bundle submission with various Siemens CT Scanner Systems. In this submission the predicate devices SOMATOM go.Now, 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 Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, 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.

{6}------------------------------------------------

## IV. Device Description

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

## Single Source CT Sacnner System:

- . SOMATOM X.cite
- Scan&GO Mobile Medical Application (optional mobile workflow component) ●

The subject device SOMATOM X.cite with SOMARIS/10 syngo CT VA30 is a Computed Tomography X-ray System which feature one (single source) continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM X.cite 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 X.cite CT scanner. 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 close proximity to 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
- O Selection of pre-defined protocols
- Scan parameter display O
- Patient table position display and gantry tilt parameter display o
- Tools and instruction message area, O
- o Patient table position planning area
- O Physiological data display
- 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
- O Patient Instruction Language ("API languages")
- O Interface to support control function for RTP Laser (e.g. LAP Laser)
- 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 SOMATOM X.cite, 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 a new software version based on 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 X.cite will support the following modifications/further developments in comparison to the predicate devices:

### 1) New/Modified Hardware

- . Table S01: Overview of Hardware modifications supported by software SOMARIS/10 syngo CT VA30

{7}------------------------------------------------

## 2) Software version SOMARIS/10 syngo CT VA30

- Table S02: Overview Software modifications of SOMATOM X.cite with syngo CT VA30 ●
The submission show configuration table and comparison table and 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<br>will be supported for the subject device with software version SOMARIS/10 syngo CT<br>VA30 and is unmodified from cleared version. |

Table S01: Overview of Hardware Modifications supported by software SOMARIS/10 syngo CT VA30

| | SOMATOM X.cite with SOMARIS/10 syngo CT VA30 | Subject Device | Subject Device |
|---|-----------------------------------------------------------------------------|----------------|----------------|
| # | hardware properties | SOMATOM X.cite | Scan&GO |
| 1 | Patient Observation Camera | Modified | N/A |
| 2 | Moodlight | Modified | N/A |
| 3 | Various Tablet Configuration | Modified | Modified |
| 4 | High Power 70 / High Power 80 | Enabled | N/A |
| 5 | Adaptive Dose Shield | Enabled | N/A |
| 6 | Tin Filter | Enabled | N/A |
| 7 | Split Filter | Modified | N/A |
| 8 | 3D Camera | Enabled | N/A |
| 9 | Other hardware modifications<br>(e.g. new bore size, enabled Vectron™ Tube) | Modified | N/A |

Table S02: Overview Software modifications of SOMATOM X.cite with syngo CT VA30

| | SOMATOM CT System Scanner with | | |
|----|-----------------------------------------------------|-----------------|----------------|
| | SOMARIS/10 syngo CT VA30 | Subject Devices | Subject Device |
| # | Software properties | SOMATOM X.cite | Scan&GO |
| 1 | MPPS | Enabled | N/A |
| 2 | Flex Dose Profile | Modified | N/A |
| 3 | Flex 4D Spiral | Modified | N/A |
| 4 | DirectDensityTM | Enabled | N/A |
| 5 | Scan&GO - Mobile Workflow | Modified | Modified |
| 6 | CT View&GO - Advanced tools | Modified | N/A |
| 7 | Check&GO - Metal Detection | New | New |
| 8 | CARE Contrast III and Contrast media protocol | Modified | N/A |
| 9 | CARE kV | Modified | N/A |
| 10 | kV and Filter independent CaScore (Artificial120) | Enabled | N/A |
| 11 | Recon&GO - Advanced Reconstruction | Modified | N/A |
| 12 | Recon&GO - Post-Processing plug in functions | Modified | N/A |
| 13 | TwinBeam Dual Energy | Modified | N/A |
| 14 | TwinSpiral Dual Energy | Modified | N/A |
| 15 | FAST Planning, FAST Window | Modified | N/A |
| 16 | HD FoV 4.0 | Enabled | N/A |
| 17 | Imaging - workflow decision tree | New | New |
| 18 | Imaging - Cardio BestPhase | Enabled | N/A |
| 19 | Multistudy | Modified | N/A |
| 20 | Multiphase | Modified | N/A |
| 21 | Respiratory Motion Management | Enabled | N/A |
| 22 | Patient Marking - Direct Laser Steering | New | New |
| 23 | Automatic Patient Instruction | Modified | N/A |
| 24 | FAST Integrated Workflow (including FAST 3D Camera) | Modified | N/A |
| 25 | ADMIRE | Enabled | 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.

{8}------------------------------------------------

## 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:

This 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 SOMATOM X.cite scanner provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software components of these scanners 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, modified gantry mechanics, tube and patient tables and Vectron x-ray tube.

Software version SOMARIS/10 syngo CT VA30 supports software that are designed as 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 X.cite 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
- 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

{9}------------------------------------------------

- 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 X.cite and the primary predicate device SOMATOM go.Top (K173632) and the predicate device SOMATOM Force (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)
- CT gantry hardware supporting large bore size and 50 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).

{10}------------------------------------------------

| | Device Comparison | | |
|---------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------|
| Hardware Property | Subject Device<br>SOMATOM X.cite | Primary Predicate Devices<br>SOMATOM go.Top<br>(K173632) | Predicate Device<br>SOMATOM Force<br>(K190578) |
| Scanner | whole body X-ray computed tomography scanner | whole body X-ray computed tomography scanner | whole body X-ray computed tomography scanner |
| Generator<br>max. power | 105 kW | 75 kW | 2x 120 kW |
| Detector<br>technologie | Stellar | Stellar | Stellar |
| Detector<br>volumen coverage | 38.4 mm | 38.4 mm | 2 x 57,6 mm |
| Detector<br>physical rows | 64 | 64 | 2 x 96 |
| Detector<br>slice width | 0.6 mm | 0.6 mm | 0.6 mm |
| Detector<br>DAS channel No. | 840 | 840 | 736<br>920 |
| Detector<br>image slices | 128 | 128 | 2 x 192 |
| Tube<br>Technologie | Vectron | Athlon | Vectron |
| Tube<br>kV steps | (in 10kV steps)<br>70 kV to 150kV | (in 10kV steps)<br>70 kV to 140kV | (in 10kV steps)<br>70 kV to 150kV |
| Tube<br>max. current | 1200 mA | 825 mA | 2 x 1300 mA |
| Tube<br>tube focus | 0.6 x 0.7<br>0.8 x 1.1 | 1.0 x 1.2<br>0.8 x 0.8 | 0.4 x 0.5/0.6 x 0.7/0.8 × 1.1<br>(for both tubes) |
| Tube<br>heat capacity | higher than 30 MHU | 6 MHU | higher than 30 MHU |
| Gantry<br>bore size | 82 cm | 70 cm | 78 cm |
| Gantry<br>FoV | 50 cm | 50 cm | 50 cm |
| Gantry<br>rotation time (sec) | 0.3, 0.5, 1.0 | 0.33, 0.5, 1.0 | 0.25, 0.285,<br>0.33, 0.5,<br>1.0 |
| Gantry<br>Tilt [degree] | +/-25 | +/-30 | N/A |
| Patient Table<br>type | Vario RT: 1.600 m,<br>Vario 2: 2.000 m | Vario 1 and Vario RT:<br>1.600 mm, Vario 2: 2.000 mm | PHS5, MPT4:<br>1.600 m or 2.000 m |
| Max. Scan length<br>Topogram | 1680 mm 2080 mm | 1600 mm, 2000 mm | 1600 mm, 2000 mm |
| Max. Scan length<br>Image acquisition | 1600 mm, 2000 mm | 1600 mm, 2000 mm | 1600 mm, 2000 mm |
| Spectral filtration<br>Option* | Combined Split Filter / Tin Filter<br>supported, plus extra Tin Filter | Combined Split Filter / Tin Filter<br>supported | Tin Filter for both tubes |
| 3D Camera<br>for patient positioning | option for patient positioning<br>with 3D Camera | N/A | option for patient positioning<br>with 3D Camera |
| High Power 70 | 1200 mA<br>(@ 70 kV) | 825 mA<br>(@ 70 kV) | 1300 mA<br>(@ 70 kV) |
| High Power 80 | 1200 mA<br>(@ 80 kV) | 825 mA<br>(@ 80 kV) | 1300 mA<br>(@ 80 kV) |

Table S03: SOMATOM X.cite 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).

Table S04: SOMATOM X.cite comparable software properties

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

| Properties<br>software | Subject Device<br>SOMATOM X.cite<br>(syngo CT VA30) | Primary Predicate Device<br>SOMATOM go.Top<br>(K173632) | Predicate Device<br>SOMATOM Force<br>(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 |
| Protocols<br>(Single Source<br>CT Scanner<br>System) | Support of :<br>Protocols for Radiation Therapy Planning support patient marking Protocols that allow scanning with support of an external respiratory gating system (ANZAI, Varian RGSC) Protocol supporting contrast bolus-triggered data acquisition Contrast media protocols Pediatric Protocols Flex Dose Profile TwinBeam DE TwinSpiral DE Flex 4D Spiral | Support of :<br>Protocols for Radiation Therapy Planning Protocol supporting contrast bolus-triggered data acquisition Pediatric Protocols | Support of :<br>Protocols for Radiation Therapy Planning Protocols that allow triggering of breath hold scanning from external device. Protocol supporting contrast bolus-triggered data acquisition Pediatric Protocols Adaptive Dose Area DualSource DE Adaptive 4D Spiral |
| post-processing<br>methods<br>(syngo CT VA30<br>enable a subset<br>of methods on<br>the scanner<br>software<br>installation –<br>only applicable<br>for previously<br>cleared syngo<br>applications) | enabled via software interface<br>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>Note 1: Detailed information<br>about the subset of enabled<br>syngo.CT functionalities are listed<br>below. | enabled via software interface<br>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.CT MM Oncology<br>syngo.CT Dual Energy<br>syngo.via (incl. MM Reading<br>ALPHA technology)<br>syngo.CT Clinical Extensions<br>syngo.CT LungCAD<br>syngo.via RT Image Suite | enabled via stand alone workplace<br>software installation<br>varies methods contained in the<br>available applications<br>The user will operate the SOM/7-<br>based scanner<br>workplace and in addition have<br>the possibility to use post-<br>processing applications provided<br>by a syngo.via-based system on<br>the acquisition workplace. |
| Cybersecurity | IT Hardening | IT Hardening | IT Hardening |
| HD FoV | HD FoV 4.0 | HD FoV 3.0 | HD FoV 4.0 |
| Standard<br>technologies | FAST Features CARE Features GO technology | FAST Features CARE Features GO technology | FAST Features CARE Features |
| FAST Integrated<br>Workflow for<br>patient<br>positioning | FAST Integrated Workflow steps supported: FAST Isocentering FAST Range FAST Direction FAST Topo FAST Planning FAST 3D Align | N/A | FAST Integrated Workflow steps supported: FAST Isocentering FAST Range FAST Direction FAST Topo FAST Planning FAST 3D Align |
| Properties<br>software | Subject Device | Primary Predicate Device | Predicate Device |
| | SOMATOM X.cite | SOMATOM go.Top | SOMATOM Force |
| | (syngo CT VA30) | (K173632) | (K190578) |
| DirectDensityTM | DirectDensityTM<br>(including relative electron<br>density and relative mass density) | N/A | DirectDensityTM<br>(including relative electron<br>density and relative mass density) |
| breath-hold<br>technique | Respiratory Motion Management<br>support breath hold triggered<br>spiral scans with manual breath<br>hold triggered examinations. | Respiratory Motion Management<br>support breath hold triggered<br>spiral scans with manual breath<br>hold triggered examinations. | Respiratory Motion Management<br>support breath hold triggered<br>spiral scans with manual breath<br>hold triggered examinations and<br>DirectBreathhold™ (automated<br>trigger supported) |
| Respiratory<br>gating scan<br>modes | Respiratory gated spiral and<br>respiratory triggered sequence<br>scan modes | Respiratory gated spiral scan<br>mode | Respiratory gated spiral scan<br>mode |
| Iterative<br>Reconstruction<br>Methods | • ADMIRE<br>• iMAR | • SAFIRE<br>• iMAR | • ADMIRE<br>• SAFIRE<br>• iMAR |

{12}------------------------------------------------

## Note 1: Detail information to support Recon&GO

The summary below provides detailed information about the subset of functionalities enabled by Recon&GO -Advanced Reconstruction.

Additional advanced reconstruction tools are provided through the advanced functionality of Recon&&GO:

- Spectral Recon (Dual Energy Reconstruction)
- Inline Results DE SPP (Spectral Post-Processing)
- Inline Results DE Ranges (Parallel/Radial) / Inline DE

Table S05: Overview of Recon&GO advanced reconstruction tools supported by SOMATOM X.cite

| Recon&GO - Advanced Reconstruction | 510(k) information of the medical device<br>software application that support<br>same reconstruction tools |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Recon&GO / Spectral Recon support image types<br>- Virtual Unenhanced<br>- Monoenergetic Plus | Reference Device K191468 -<br>syngo.CT Dual Energy |
| Recon&GO / Inline Results DE SPP support<br>- Dual Energy Spectral Post-Processing | Reference Device K191468 -<br>syngo.CT Dual Energy |
| Recon&GO - Inline Results DE Ranges support the application<br>classes:<br>- Bone Removal/Direct Angio<br>- Liver VNC<br>- Monoenergetic +<br>- Virtual Unenhanced<br>- Lung Analysis<br>- Gout<br>- Kidney Stones*)<br>- Bone Marrow<br>- Brain Hemorrhage<br>- Rho/Z<br>- Liver Fat Map | Reference Device K191468 -<br>syngo.CT Dual Energy |
| *) Kidney Stones is designed to support the visualization of the<br>chemical composition of kidney stones and especially the<br>differentiation between uric acid and non-uric acid stones. For<br>full identification of the kidney stone additional clinical<br>information should be considered such as patient history and<br>urine testing. Only a well-trained radiologist can make the final<br>diagnosis under consideration of all available information. The<br>accuracy of identification is decreased in obese patients. | |

{13}------------------------------------------------

| Recon&GO - Advanced Reconstruction | 510(k) information of the medical device<br>software application that support<br>same reconstruction tools |
|------------------------------------|------------------------------------------------------------------------------------------------------------|
| | |

The summary below in Table S06 provides detailed information about the subset of functionalities enabled by Recon&GO - Post-Processing plug in functions.

Table S06: Overview of Recon&GO Inline Results post-processing methods supported by SOMATOM X.cite

| Enabled Recon&GO - Post-Processing plug in<br>functions | 510(k) information of the medical device software<br>application that support same established post-<br>processing methods |
|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Heart Isolation, Coronary Tree,<br>Vessel Ranges (LAD, RCA, CX), Cardiac Ranges | Reference Device K173637 - syngo.CT Coronary<br>Analysis |
| Vascular ranges (Aorta, Carotis L Int., Carotic R Int.,<br>Runoff L, Runoff R)<br>Inline Table removal, Inline Bone removal | Reference Device K173637 - syngo.CT Vascular<br>Analysis |
| Radial Rib Ranges, Parallel Rib Ranges and Spine<br>Range | Reference Device K123584 - syngo.CT Bone<br>Reading |

Any differences in technological characteristics do not raise different questions of safety and effectiveness. Siemens believes that the subject device is substantially equivalent to the predicate devices. Testing and validation is completed. Test results show that the subject device SOMATOM X.cite, is comparable to the predicate devices SOMATOM go.Top (K173632) and SOMATOM Force (K190578) in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.

## VII. Performance Data

## Non-Clinical Testing

Non-clinical test (integration and functional) including phantom tests were conducted for the SOMATOM X.cite during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

The general purpose of each tests is to verify and validate the functionality of the subject device modifications.

Testing will cover all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:

## System Test (ST):

- Acceptance test (workflow and user manual test) ●
- Legal and Regulatory test .
- System Integration Test (SIT):
- System Integration Test (functional) ●
- Image Quality (IQ) test ●
- DICOM tests

## Subsystem Integration Test (SSIT):

- Subsystem Integration Test ●
- . DICOM tests

Tests are conducted for all software components developed in product development and for the complete product itself. Several activities are taken into account for this process, including creation of test specifications that relate to software requirements including tests to address risk mitigations that are identified, documented and traced by hazard keys.

Additional evaluation tests are performed as bench test to support the new device modification on Non-Clinical Performance Testing as listed in table S07 below.

## Table S07: Non-Clinical Performance Testing

{14}------------------------------------------------

| # | Feature/Non-Clinical Supportive Testing | Document Title | Testing Performed |
|----|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 01 | kV and Filter independent CaScore | Evaluation of DirectDensity and Artificial120 kernels on Somaris/10 VA30 | The test results show that performance of special kernel variants Artifical120 and eDDensity and mDDensity is similar or improved within the limits of accuracy of the test com-pared to the respective initial release versions. In conclusion, the features DirectDensity and Calcium Scoring at any kV have been enabled for the release SOMARIS/10 VA30. |
| 02 | Recon&GO - Spectral Recon | Detailed Description and Bench Test for the Feature "Spectral Recon" | Deviations between the already cleared image processing algorithms in Inline DE and the new technical realization "Spectral Recon" are extremely small and are not expected to have any impact on the diagnostic performance. Residual deviations are a consequence of rounding differences and slight differences in implementation. |
| 03 | TwinSpiral Dual Energy / TwinSpiral DE | Detailed Description and Bench Test<br>for the Feature "TwinSpiral" | Based on these results it can be stated that the TwinSpiral Dual Energy CT scan mode provides CT-images of diagnostic quality, which are similar to conventional 120kV images in terms of CT-values and image noise at same radiation dose. The mixed images show a slight reduction in the iodine CT-value, but at the same time image noise at same dose is also lower. So in combination the iodine CNR at same radiation dose is comparable between Mixed images and 120kV images. |
| 04 | Flex 4D Spiral - Neuro/Body | Flex4D Spiral: Technical principals and demonstration of freely selectable scan ranges (Somaris/10 VA30) | Scan ranges with the new Flex4D Spiral feature can be freely selected within the limits mandated by the scan mode and protocol. The scanned volume was found to be in agreement with the planned scan range for a variety of different tested scan modes, scan lengths and scanners.<br>Radiochromic film placed in the isocenter for a variety of scan ranges showed that the irradiated range markers displayed by the scanner acquisition software during the planning of the respective F4DS scans were in good agreement with the exposed area on the film. |
| 05 | DirectDensity | Evaluation of DirectDensity and Artificial120 kernels on Somaris/10 VA30 | Evaluation of phantom images to demonstrate the subject device features ability to provide images that can be shown as relative mass density or relative electron density. The conducted test performed demonstrated the subject device's ability to show relative mass or relative electron density images. |
| 06 | HD FoV | HDFoV 4.0: Technical principles and phantom measurements evaluating HU accuracy and skin-line accuracy in the extended field of view (FoV) region (Som/10 VA30) | Phantom testing conducted to assess the subject device ability to provide visualization of anatomies outside the standard field of view and that the image quality standards for radiotherapy applications are met. |
| 07 | Contrast media protocol | Siemens Healthineers factory contrast protocols and comparison to approved drug labeling…