← Product Code [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK) · K211373 # SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software (K211373) _Siemens Medical Solutions USA, Inc. · JAK · Aug 27, 2021 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K211373 ## Device Facts - **Applicant:** Siemens Medical Solutions USA, Inc. - **Product Code:** [JAK](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK.md) - **Decision Date:** Aug 27, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1750 - **Device Class:** Class 2 - **Review Panel:** Radiology ## 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 Computed tomography (CT) scanner systems (SOMATOM go. and X. platforms) generate cross-sectional images via computer reconstruction of X-ray transmission data; utilizes continuously rotating tube-detector system; fan beam principle. Operated by trained staff/physicians in clinical settings; includes optional Scan&GO mobile workflow via wireless tablet/PC for patient positioning, protocol selection, and scan parameter display. Does not trigger scans or store images. Output images used for diagnosis, treatment planning (e.g., radiation therapy, surgery), and low-dose lung cancer screening. System includes hardware/software updates (SOMARIS/10 syngo CT VA40) and optional CT-guided intervention tools (myNeedle Guide/Laser). Benefits include optimized workflow, reduced radiation dose, and improved diagnostic accuracy through iterative reconstruction and high-resolution imaging. ## Clinical Evidence Bench testing only. No clinical trials performed for this submission. Evidence includes phantom testing (anthropomorphic heart/respiratory phantoms), image quality evaluations (CNR, noise power spectra), and accuracy testing for laser-guided interventions. Lung cancer screening claim supported by reference to National Lung Screening Trial (NLST) literature. ## Technological Characteristics Whole-body X-ray CT scanner; fan beam geometry; Stellar/Stellar Infinity detector technology; Vectron/Athlon/Chronon X-ray tubes. Connectivity: DICOM, wireless tablet integration (IEEE 802.11h). Software: SOMARIS/10 syngo CT VA40 (Windows-based). Iterative reconstruction (ADMIRE, iMAR). Standards: IEC 60601-1, IEC 60601-2-44, NEMA XR 25/28, DICOM PS 3.1-3.20. ## Regulatory 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, Scan&GO ([K200524](/device/K200524.md)) ## Reference Devices - SOMATOM go.Top ([K200524](/device/K200524.md)) - SOMATOM go.Open Pro ([K200524](/device/K200524.md)) - SOMATOM Force ([K190578](/device/K190578.md)) ## Related Devices - [K200524](/device/K200524.md) — SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO · Siemens Medical Solutions USA, Inc. · Apr 1, 2020 - [K192061](/device/K192061.md) — SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO · Siemens Medical Solutions USA, Inc. · Nov 21, 2019 - [K173632](/device/K173632.md) — SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO · Siemens Medical Solutions USA, Inc. · Apr 13, 2018 - [K250822](/device/K250822.md) — SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse · Siemens Medical Solutions USA, Inc. · Jul 3, 2025 - [K190578](/device/K190578.md) — SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence · Siemens Medical Solutions USA, Inc. · Jun 27, 2019 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. Siemens Medical Solutions USA, Inc. % Alaine Medio Regulatory Affairs Professional 810 Innovation Drive KNOXVILLE TN 37932 Re: K211373 Trade/Device Name: SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite SOMATOM X.ceed, Scan&GO Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: April 30, 2021 Received: May 4, 2021 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. August 27, 2021 {1}------------------------------------------------ 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara 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) K211373 #### Device Name SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite, SOMATOM X.ceed, Scan&GO Software #### 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}------------------------------------------------ #### 510(k) Summary FOR ## SOMATOM GO. PLATFORM AND SOMATOM X. PLATFORM #### CT Scanner Systems #### - Software version SOMARIS/10 syngo CT VA40 Submitted by: Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville. TN 37932 Date Prepared: February 21, 2021 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 Regulatory Affairs Siemens Medical Solutions USA, Inc. (865) 206-0337 (work cell) (865) 218-3019 FAX alaine.medio@siemens-healthineers.com {4}------------------------------------------------ ## II. Device Name and Classification | Product Names: | SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All,<br>SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro<br>SOMATOM X.cite, SOMATOM X.ceed, Scan&GO Software | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Names: | SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All,<br>SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro<br>SOMATOM X.cite, SOMATOM X.ceed, Scan&GO Software | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | ## III. Predicate Device ### Primary Predicate Device: | Trade Names: | SOMATOM X.cite, Scan&GO | |-----------------------|---------------------------------------------------------------------------------| | 510(k) Number: | K200524 | | Clearance Date: | April 01, 2020 | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | | Recall Information: | All predicate device recalls have been considered in the subject device design. | ### Reference Device: | Trade Name: | SOMATOM go.Top, SOMATOM go.Open Pro | |-----------------------|---------------------------------------------------------------------------------| | 510(k) Number: | K200524 | | Clearance Date: | April 01, 2020 | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | | Recall Information: | All predicate device recalls have been considered in the subject device design. | Note: K200524 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, SOMATOM X.cite and Scan&GO software. {5}------------------------------------------------ | Reference Device: | | | |-----------------------|------------------------------------------------------------------------------------|--| | Trade Name: | SOMATOM Force | | | 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: | All predicate device recalls have been considered in the subject<br>device design. | | In this submission, the primary predicate device SOMATOM X.cite including Scan&GO and the reference devices SOMATOM go.Top and SOMATOM Force are being used, to demonstrate substantial equivalence of technological characteristics. ### IV. Device Description Siemens intends to update software version, SOMARIS/10 syngo CT VA40 for Siemens SOMATOM Computed Tomography (CT) Scanner Systems with unmodified mobile workflow options. This update also includes optional hardware for CT guided intervention workflow for the X. platform supporting CT Scanner Systems. ### 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 Software (optional mobile workflow component) ● ### SOMATOM X. platform is comprised of the following 2 CT scanners and optional mobile workflow: - SOMATOM X.cite - SOMATOM X.ceed (new CT Scanner Model) - Scan&GO Software (optional mobile workflow component) . The subject device SOMATOM go. platform and SOMATOM X. platform with SOMARIS/10 syngo CT VA40 are Computed Tomography X-ray Systems which feature one continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go. platform and SOMATOM X. platform with software SOMARIS/10 syngo CT VA40 produces CT images in DICOM format. These images can be used by trained staff for post-processing applications commercially distributed by Siemens Medical Solutions USA, Inc. 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. {6}------------------------------------------------ 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 workflow of the subject device platform CT scanners. Scan&GO can be operated on a Siemens provided various tablet hardware 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 Wi-Fi connection 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 - O Tools and instruction message area, - Patient table position planning area O - 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") - 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, syngo CT VA40 (SOMARIS/10 syngo CT VA40), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform provides a software plugin interface that allows for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version. Software version syngo CT VA40 (SOMARIS/10 syngo CT VA40) is an update to software version syngo CT VA30A (SOMARIS/10 syngo CT VA30) which was cleared for the primary predicate devices in K200524 and supports the same plugin interfaces for the optional Scan&GO mobile workflow and integration of post-processing tasks as the predicate devices. {7}------------------------------------------------ ### 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. ### VI. Comparison of Technological Characteristics with the Predicate Device The subject devices (SOMATOM go. platform scanners, SOMATOM X. platform 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 new syngo CT VA40 software supports the software update of existing CT Scanner Systems SOMATOM go. platform and SOMATOM X.cite. In addition, the software version syngo CT VA40 support the new CT scanner model SOMATOM X.ceed. The new syngo CT VA40 software reuses all unmodified software features of the legacy software syngo CT VA30 cleared for the primary predicate device SOMATOM X.cite in K200524 and described below in the section "Unmodified Features used in the Subject Devices". The SOMATOM X. platform also supports an optional laser component for a modified CT guided intervention workflow. As with the primary predicate device SOMATOM X.cite, the subject devices CT Scanner Systems in combination with Scan&GO support an optional mobile workflow has also been modified to enable a new tablet hardware iPad with iPad OS operating software that support subject device Scan&GO mobile medical application software installation. SOMARIS/10 syngo CT VA40 is designed to reuse hardware independent extended functionalities and GO technologies provided by Siemens cleared commercially available software applications. The intended use and fundamental scientific technology for these independent software applications are unchanged from their cleared and released software when incorporated for use on the SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite and SOMATOM X.ceed CT scanner systems. ### The subject and predicate devices are based on the following same technological elements: - . Scanner Principle- Whole body X-Ray Computed Tomography Scanner {8}------------------------------------------------ - 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) - Support of interfaces to access 3D Camera operation for fast patient positioning workflow - Scanner display and control functionality - Remote Scan Control - Support of CT Guided Interventional 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 and Interfaces 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, SOMATOM X.ceed and the primary predicate device SOMATOM X.cite and the reference device SOMATOM go.Top cleared in K200524: - Software version SOMARIS/10 syngo CT VA40 - Additional options for Inline Results and GO technologies - CT guided intervention – modified hardware and software application - Precision Matrix function ### The following technological differences exist between the subject device Scan&GO and the predicate device Scan&GO cleared in K200524: - Software version SOMARIS/10 syngo CT VA40 - iPad hardware to support mobile workflow options - CT guided intervention – modified software application The SOMATOM go. platform and SOMATOM X. platform will support the following modifications/further developments in comparison to the predicate devices: #### 1) New/Modified Hardware - Table S5-02: Overview of hardware modifications ● #### 2) Software version SOMARIS/10 syngo CT VA40 - Table S5-03: Overview software modifications {9}------------------------------------------------ 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 predicate / reference devices | | Unmodified | This feature remains unchanged from the predicate device | | enabled | This feature is currently supported by other cleared Siemens CT systems or cleared Siemens stand<br>alone software applications. This feature will be supported for the subject device with software<br>version SOMARIS/10 syngo CT VA40 and is substantially equivalent compared to the cleared version. | Table S5-01: Overview term definition Table S5-02: Overview of hardware modifications in comparison to the corresponding predicate devices | | CT Scanner Systems with<br>SOMARIS/10 syngo CT<br>VA40 | Subject Devices | | | | | | |----|-------------------------------------------------------------------------------------|-----------------------------|-------------------|-------------------|-----------------------------------|-------------------|-------------------| | | Hardware properties | SOMATOM<br>go.Now/<br>go.Up | SOMATOM<br>go.All | SOMATOM<br>go.Top | SOMATOM<br>go.Sim/<br>go.Open Pro | SOMATOM<br>X.cite | SOMATOM<br>X.ceed | | 01 | CT guided intervention:<br>myNeedle Laser (part of<br>myNeedle Companion) | N/A | N/A | N/A | N/A | new | new | | 02 | Tablet hardware for<br>Scan&GO - iPad | modified | modified | modified | modified | modified | modified | | 03 | CT Detector - Fan<br>geometry | unmodified | unmodified | unmodified | unmodified | unmodified | Modified | | 04 | UHR imaging-Ultra High<br>Resolution for sub<br>millimeter anatomical<br>structures | N/A | N/A | N/A | N/A | N/A | enabled¹ | | 05 | Patient Table<br>Configuration | unmodified | unmodified | unmodified | unmodified | modified | modified | 1Note 1: This feature is cleared in K190578 – SOMATOM Force with SOMARIS/7 and enabled on SOMARIS/10 for the supporting subject devices. Table S5-03: Overview software modifications of SOMATOM go. platform and SOMATOM X. platform with syngo CT VA40 | | | Subject<br>Devices | Subject<br>Device | Subject Device | Subject Devices | Subject Device | Subject Device | |----|------------------------------------------------------------------------------------|-----------------------------|-------------------|-------------------|-----------------------------------|-------------------|-------------------| | | | SOMATOM<br>go.Now/<br>go.Up | SOMATOM<br>go.All | SOMATOM<br>go.Top | SOMATOM<br>go.Sim/<br>go.Open Pro | SOMATOM<br>X.cite | SOMATOM<br>X.ceed | | | Software<br>properties | | | | | | | | 01 | Precision<br>Matrix<br>(10242) (large<br>image<br>matrices) | N/A | N/A | enabled1 | enabled1 | enabled1 | enabled1 | | 02 | CT guided<br>intervention:<br>myNeedle<br>Guide (part of<br>myNeedle<br>Companion) | modified | modified | modified | modified | modified | modified | | 03 | Flex 4D Spiral<br>- Neuro /<br>Body | N/A | unmodified | unmodified | unmodified | modified | modified | {10}------------------------------------------------ | | | Subject<br>Devices | Subject<br>Device | Subject Device | Subject Devices | Subject Device | Subject Device | |----|-----------------------------------------------------------------------------------------------|-----------------------------|-------------------|--------------------|-----------------------------------|-------------------|-------------------| | | Software<br>properties | SOMATOM<br>go.Now/<br>go.Up | SOMATOM<br>go.All | SOMATOM<br>go. Top | SOMATOM<br>go.Sim/<br>go.Open Pro | SOMATOM<br>X.cite | SOMATOM<br>X.ceed | | 04 | CT<br>projection rea<br>d-<br>out frequency<br>- 8kHz<br>imaging | N/A | N/A | N/A | N/A | N/A | modified | | 05 | Imaging -<br>Cardio<br>BestPhase | N/A | unmodified | unmodified | unmodified | unmodified | enabled2 | | 06 | ADMIRE | N/A | enabled2 | enabled2 | N/A | unmodified | enabled2 | | 07 | UHR imaging-<br>Ultra High<br>Resolution for<br>sub<br>millimeter<br>anatomical<br>structures | N/A | N/A | N/A | N/A | N/A | enabled1 | | 08 | Cardiac CT<br>imaging -<br>Motion<br>artifact<br>reduced ECG-<br>gated imaging | N/A | unmodified | unmodified | unmodified | unmodified | modified | | 09 | Motion<br>artifact<br>reduced non-<br>gated imaging | N/A | unmodified | unmodified | unmodified | unmodified | modified | | 10 | myExam<br>Satellite | N/A | N/A | modified | modified | modified | modified | 1Note 1: This feature is cleared in K190578 – SOMATOM Force with SOMARIS/7 and enabled on SOMARIS/10 for the supporting subject devices. ²Note 2: This feature is cleared in K200524 – SOMATOM X.cite with SOMARIS/10 and enabled for the supporting subject devices. 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 VA40 will be offered as an optional upgrade for the existing SOMATOM CT go. platform Systems and SOMATOM X.cite. A tabular summary of the comparable hardware properties between the subject devices SOMATOM go. platform and SOMATOM X. platform CT Scanner Systems with software version syngo CT VA40 and the predicate device are listed in Table S5-04 and Table S5-05 below (modifications are in gray shaded sections). {11}------------------------------------------------ | | SOMATOM go. platform - Device Comparison (Single Source Systems) | | | | | | | Hardware Property | Subject Devices | | Primary Predicate<br>Device | |----------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------|----------------------------------------|------------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------| | | Subject Device | | | | | | Primary<br>Predicate | | SOMATOM X.cite<br>with syngo CT VA40 | SOMATOM X.ceed<br>with syngo CT VA40 | SOMATOM X.cite<br>(K200524)<br>syngo CT VA30 | | Hardware 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 | SOMATOM<br>X.cite<br>(K200524) | Scanner | whole body X-ray computed tomography<br>scanner | whole body X-ray computed tomography<br>scanner | whole body X-ray<br>computed tomography<br>scanner | | whole body X-ray computed tomography scanner | | | | | | | | Generator<br>max. power | 90kW/105kW | 105kW/120kW | 105 kW | | Scanner | Detector<br>technology | Stellar Infinity | Stellar Infinity | Stellar Infinity | | | | | | | | | Generator<br>max. power | 32 kW | 32 kW | 75 kW | 75 kW | 75 kW | 75 kW | 105 kW | Detector<br>volume coverage | 38.4 mm | 38.4 mm | 38.4 mm | | Detector<br>technology | Stellar | Stellar | Stellar | Stellar | Stellar | Stellar | Stellar Infinity | Detector<br>physical rows | 64 | 64 | 64 | | Detector<br>volume coverage | 11.2 mm | 22.4 mm | 22.4 mm | 38.4 mm | 19.2 mm | 38.4 mm | 38.4 mm | Detector<br>slice width | 0.6 mm | 0.6 mm | 0.6 mm | | Detector<br>physical rows | 16 | 32 | 32 | 64 | 32 | 64 | 64 | Detector<br>DAS channel No. | 840 | 920 | 840 | | 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>image slices | 128 | 128 | 128 | | Detector<br>DAS channel No. | 768 | 768 | 768 | 840 | 920 | 920 | 840 | Tube<br>Technology | Vectron | Vectron | Vectron | | Detector<br>image slices | 32 | 64 | 64 | 128 | 64 | 128 | 128 | Tube<br>kV steps | (in 10kV steps)<br>70 kV to 150kV | (in 10kV steps)<br>70 kV to 150kV | (in 10kV steps)<br>70 kV to 150kV | | Tube<br>Technology | Chronon | Chronon | Athlon | Athlon | Athlon | Athlon | Vectron | Tube<br>max. current | 10 mA ~ 1100 mA; ≤ ±20% for 90 kW<br>10 mA ~ 1200 mA; ≤ ±20% for 105 kW | 10 mA ~ 1200 mA; ≤ ±20% for 105 kW<br>10 mA ~ 1300 mA; ≤ ±20% for 120 kW | 1200 mA | | Tube<br>kV steps | 80kV, 110kV, 130kV | | | (in 10kV steps)<br>70 kV to 140 kV | | | (in 10kV steps)<br>70 kV to 150 kV | Tube<br>tube focus | 0.6 x 0.7 mm<br>0.8 x 1.1 mm | min. 0.6 x 0.7 mm (w/o comb)<br>min. 0.4 x 0.5 mm (with comb) | 0.6 x 0.7 mm<br>0.8 x 1.1 mm | | Tube<br>max. current | 400 mA | 400 mA | 825 mA | 825 mA | 825 mA | 825 mA | 1200 mA | Tube<br>heat capacity | higher than 30 MHU | higher than 30 MHU | higher than 30 MHU | | 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 | Gantry<br>bore size | 82 cm | 82 cm | 82 cm | | Tube<br>heat capacity | 3.5 MHU | 3.5 MHU | 6 MHU | 6 MHU | 6 MHU | 6 MHU | >30 MHU | Gantry<br>FoV | 50 cm | 50 cm | 50 cm | | Gantry<br>bore size | 70 cm | 70 cm | 70 cm | 70 cm | 85 cm | 85 cm | 82 cm | Gantry<br>rotation time (sec) | 0.3s/360°, 0.5s/360°, 1.0s/360° | 0.25s/360°, 0.3s/360°, 0.5s/360°,<br>1.0s/360° | 0.3, 0.5, 1.0 | | Gantry<br>Scan FoV | 50 cm | 50 cm | 50 cm | 50 cm | 60 cm | 60 cm | 50 cm | Gantry<br>Tilt [degree] | '+/- 30° opt<br>+/- 25° std | '+/- 30° opt<br>+/- 25° std | +/- 25 | | Gantry<br>rotation time (sec) | | 0.8, 1.0, 1.5 | | 0.33, 0.5, 1.0 | | 0.35, 0.5, 1.0 | 0.3, 0.5, 1.0 | Patient Table<br>type | Vario RT: 1600mm,<br>Vario 2: 2000mm<br>Vitus: 2000mm | Vario RT: 1600mm,<br>Vario 2.D: 2000mm,<br>Vitus: 2000mm | Vario RT: 1600mm,<br>Vario 2: 2000mm | | Gantry<br>Tilt [degrees] | N/A | +/-25 | +/-25 | +/-25 | +/-25 | +/-25 | +/-25 | Max. Scan length<br>Topogram | VARIO RT: 1680 mm<br>Vario 2: 2080 mm<br>Vitus: 2080 mm | VARIO RT:<br>1680 mm<br>Vario 2.D:<br>2080 mm<br>Vitus:<br>2080 mm | VARIO RT: 1680 mm<br>Vario 2: 2080 mm | | Patient Table<br>type | Vector:<br>1250 mm<br>Vario 1/Vario<br>RT: 1600 mm<br>with table<br>extension | Vario 1 (1600 mm, Vario 2 (2000m and<br>Vario RT: 1600 mm with table extension | | | Vario 2 (2000mm and<br>Vario RT: 1600 mm with<br>table extension | | Vario RT: 1600<br>mm with table<br>extension<br>Vario 2: 2000<br>mm with table<br>extension | Max. Scan length<br>Image acquisition | VARIO RT:<br>1600 mm<br>Vario 2:<br>2000 mm<br>Vitus:<br>2000 mm | VARIO RT:<br>1600 mm<br>Vario 2.D:<br>2000 mm<br>Vitus:<br>2000 mm | VARIO RT:1600 mm<br>Vario 2: 2000 mm | | Max. Scan 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 2080<br>mm | Spectral filtration<br>Option* | Combined Split Filter / Tin Filter<br>supported, plus extra Tin Filter | Combined Split Filter / Tin Filter<br>supported, plus extra Tin Filter | Combined Split Filter /<br>Tin Filter supported,<br>plus extra Tin Filter | | Max. Scan length<br>Image 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, 2000<br>mm | 3D Camera | supported | supported | supported | | Spectral filtration<br>option | Tin Filter<br>supported | Tin Filter<br>supported | Tin Filter<br>supported | Combined<br>Split Filter/Tin<br>Filter | Tin Filter<br>supported | Combined<br>Split Filter/Tin<br>Filter | Combined Split<br>Filter / Tin Filter<br>supported, plus<br>extra Tin Filter | High Power 70<br>(@70kV) | 90kW Gen. @70kV = 1100mA<br>105kW Gen. @70kV = 1200mA | 105kW Gen. @70kV = 1200mA<br>120kW Gen. @70kV = 1300mA | 1100 mA<br>1200 mA | | 3D Camera | N/A | | | supported | | | supported | High Power 80<br>(@80KV) | 90kW Gen. @80kV = 1100mA<br>105kW Gen. @80kV = 1200mA | 105kW Gen. @80kV = 1200mA<br>120kW Gen. @80kV = 1300mA | 1100 mA<br>1200 mA | | High Power 70 (@70kV) | N/A | N/A | 825 mA | 825 mA | 825 mA | 825 mA | 1200 mA | | | | | | High Power 80 (@80kV) | N/A | N/A | 825 mA | 825 mA | 825 mA | 825 mA | 1200 mA | | | | | | Respiratory<br>Gating | | Anzai - AZ, Varian - RGSC | | | | Anzai - AZ, Varian - RGSC | | Anzai - AZ, Varian<br>– RGSC | | | | | Gating<br>sensor | | | | | | | | | | | | # Table S5-04: SOMATOM go. platform comparable hardware properties {12}------------------------------------------------ # Table S5-05: SOMATOM X. platform comparable hardware properties (modified) {13}------------------------------------------------ | Laser supported workflow | Laser in combination with FAST Isocentering visualize coordinates for patient isocenter position.<br>myNeedle Laser visualize coordinates for intervention | Laser in combination with FAST Isocentering visualize coordinates for patient isocenter position.<br>myNeedle Laser visualize coordinates for intervention | Laser in combination with FAST Isocentering visualize coordinates for patient isocenter position | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| The tabular summary of the comparable software properties between the subject devices with software version SOMARIS/10 syngo CT VA40 and the predicate devices are listed in Table S5-06 below (modifications are in gray shaded sections). | Table S5-06: SOMATOM go. platform and SOMATOM X. platform comparable software properties | | | |------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | Subject Device | Predicate Device (K200524) | | | SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite, SOMATOM X.ceed | SOMATOM X.cite | | Software Property | | | | | syngo CT VA40 | syngo CT VA30 | | | Windows based | Windows based | | Operating System | SOMARIS/10 syngo CT VA40 (with additional<br>software options) | SOMARIS/10 syngo CT VA30A | | | syngo Acquisition Workplace (AWP) | syngo Acquisition Workplace (AWP) | | | syngo Viewing, syngo Filming and syngo Archiving<br>& Networking | syngo Viewing, syngo Filming and syngo Archiving<br>& Networking | | Acquisition Workplace | Image Reconstruction | Image Reconstruction | | | 2nd Acquisition Workplace supported with<br>myExam Satellite | No 2nd Acquisition Workplace supported | | Stellar Detector | Stellar detector firmware supported | Stellar detector firmware supported | | Teamplay | Support teamplay Protocols | Support teamplay Protocols | | | Protocols for Radiation Therapy Planning<br>support patient marking Protocol supporting contrast bolus-triggered<br>data acquisition Contrast media protocols Pediatric Protocols Flex Dose Profile TwinBeam DE TwinSpiral DE Flex 4D Spiral Protocols that allow scanning with support of<br>an 3rd party respiratory gating system (ANZAI,<br>Varian RGSC) | Protocols for Radiation Therapy Planning<br>support patient marking Protocol supporting contrast bolus-triggered<br>data acquisition Contrast media protocols Pediatric Protocols Flex Dose Profile TwinBeam DE TwinSpiral DE Flex 4D Spiral Protocols that allow scanning with support<br>of an 3rd party respiratory gating system<br>(ANZAI, Varian RGSC) | | Protocols | | | | | Advanced reconstruction tools supported: | Advanced reconstruction tools supported: | | | Spectral Recon (Dual Energy Reconstruction) Inline Results DE SPP (Spectral Post-<br>Processing) Inline Results DE Ranges (Parallel/Radial) /<br>Inline DE | Spectral Recon (Dual Energy Reconstruction) Inline Results DE SPP (Spectral Post-<br>Processing) Inline Results DE Ranges (Parallel/Radial) /<br>Inline DE | | Recon&GO - Advanced<br>Reconstruction. | | | | | Subject Device | Predicate Device (K200524) | | Software Property | • 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>• SOMATOM X.ceed | • SOMATOM X.cite | | | syngo CT VA40 | syngo CT VA30 | | Post-Processing plug in functions | enabled via software interface Recon&GO - Inline Results<br>(various methods of cleared software applications | enabled via software interface Recon&GO - Inline Results<br>various methods of cleared software applications | | Cybersecurity | IT Hardening | IT Hardening | | HD FoV | HD FoV 4.0 | HD FoV 4.0 | | Standard technologies | • FAST Features<br>• CARE Features<br>• GO technology | • FAST Features<br>• CARE Features<br>• GO technology | | CT Guided Intervention | Guide&GO or<br>myNeedle Guide<br>(Note: Guide&GO is not supported by SOMATOM X.ceed) | Guide&GO… --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K211373](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K211373) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAK/K211373