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 staff as an aid in diagnosis, treatment, and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

*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 Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB20 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

a) Single Source CT Scanner systems (SOMATOM go. Platform):

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

In this submission, the above listed CT scanner systems are jointly referred to as subject devices by "SOMATOM go. Platform" CT scanner systems.

b) Dual Source CT Scanner system:

SOMATOM Pro.Pulse

The above listed subject devices with SOMARIS/10 syngo CT VB20 are Computed Tomography X-ray Systems which feature one (Single Source) or two (Dual Source) continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go. Platform and the SOMATOM Pro.Pulse with software SOMARIS/10 syngo CT VB20 produce CT images in DICOM format, which can be used by trained staff for software applications, e.g. 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.

AI/ML Overview

The provided FDA 510(k) Clearance Letter for the SOMATOM CT Systems focuses heavily on establishing substantial equivalence to predicate devices through comparisons of technological characteristics, hardware, and software. It generally asserts that the device has met performance criteria through verification and validation testing, but it does not provide a detailed "Acceptance Criteria Table" with specific quantitative metrics and reported device performance. Similarly, it describes the types of studies performed (e.g., bench testing, retrospective blinded rater study), but it lacks the specific details requested regarding sample sizes, data provenance, expert qualifications, and effect sizes that would typically be found in a detailed study report.

Therefore, I will extract and synthesize the information that is available in the document and explicitly state where the requested information is not provided.

Understanding the Device and its Changes

The devices under review are Siemens SOMATOM CT Systems (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, and SOMATOM Pro.Pulse) with a new software version, SOMARIS/10 syngo CT VB20. This new software version builds upon the previous VB10 version cleared in K233650 and K232206.

The submission focuses on modifications and new features introduced with VB20, including:

Eco Power Mode: New feature for reduced energy consumption during idle times (not supported on go.Now and go.Up).
Oncology Exchange: New feature for transferring prescription information from ARIA Oncology Information System.
myExam Contrast: New feature for exchanging contrast injection parameters.
FAST 3D Camera/FAST Integrated Workflow: Modifications including retrained algorithms, collision indication, and Centerline/Grid Overlay.
FAST Planning: Extended to detect additional body regions.
myExam Companion (myExam Compass/myExam Cockpit): Clinical decision trees now available for child protocols.
HD FoV 5.0: New extended field of view reconstruction algorithm (for go.Sim and go.Open Pro only).
CT guided intervention – myAblation Guide interface: New interface.
Flex 4D Spiral: Modifications regarding dynamic tube current modulation.
ZeeFree RT: New stack artifact reduced reconstruction for respiratory-related examinations (for go.Open Pro only).
DirectDensity: Modified to include stopping-power ratio (Kernel St).
DirectLaser: Patient Marking workflow improvement.
Respiratory Motion management - Open Online Interface: New interface for respiratory gating.
DirectSetup Notes: Enabled for certain SOMATOM go. Platform systems.

The core argument for clearance is substantial equivalence to predicate devices. This means that, despite modifications, the device is as safe and effective as a legally marketed device (the predicates).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table of quantitative acceptance criteria with corresponding reported device performance values. Instead, it describes general acceptance criteria related to verification and validation tests and then provides qualitative statements about the test results demonstrating comparability or improvement over predicate devices.

Here's a summary of the described performance evaluations:

Feature/Metric	Acceptance Criteria (Qualitative)	Reported Device Performance (Qualitative)
Overall	Meet acceptance criteria for all software specifications. Enable safe and effective integration. Perform as intended in specified use conditions.	"All software specifications have met the acceptance criteria." "Verification and validation support the claims of substantial equivalence." "Perform(s) as intended in the specified use conditions." "As safe, as effective, and perform as well as or better than the predicate devices."
FAST 3D Camera Accuracy (Isocentering, Range, Direction)	Comparable or better accuracy to predicate device for adults; extend support to adolescents.	"Overall, the subject devices with syngo CT VB20 delivers comparable or improved accuracy to the predicate devices with syngo CT VB10 predicate device for adults and extends the support to adolescents."
FAST Planning Correctness	High fraction (percentage) of ranges calculated correctly and without needing change. Meets interactive requirements (fast calculation time).	"For more than 90% of the ranges no editing action was necessary to cover standard ranges." "For more than 95%, the speed of the algorithm was sufficient."
HD FoV 5.0 Performance (vs. HD FoV 4.0)	As safe and effective as HD FoV 4.0.	"Results obtained with the new HD FoV 5.0 algorithm are compared with its predecessor, the HD FoV 4.0 algorithm, based on physical and anthropomorphic phantoms...This comparison is conducted to demonstrate that the HD FoV 5.0 algorithm is as safe and effective as the HD FoV 4.0 algorithm." (No quantitative metrics provided in this document excerpt regarding this comparison's outcome).
Flex 4D Spiral Functionality & Image Quality	Proper function and acceptable image quality.	"The performed bench test report describes the technical background of Flex 4D Spiral and its functionalities with SOMATOM CT scanners, demonstrate the proper function of those, and assess the image quality of Flex 4D Spiral." (No quantitative metrics provided)
ZeeFree RT Reconstruction Performance	No relevant errors in CT values and noise in homogeneous phantoms. No relevant errors in CT values in tissue-equivalent phantoms. No relevant geometrical distortions in static phantoms. No relevant deteriorations of position/shape in dynamic phantoms. No relevant new artifacts. Maintain performance with iMAR. Independent of detector width.	"introduces no relevant errors in terms of CT values and noise levels measured in a homogeneous water phantom" "introduces no relevant errors in terms of CT values measured in a phantom with tissue-equivalent inserts, even in the presence of metals and in combination with the iMAR algorithm" "introduces no relevant geometrical distortions in a static torso phantom" "introduces no relevant deteriorations of the position or shape of a dynamic thorax phantom" "does not introduce relevant new artefacts" "can be successfully applied in combination with metal artifact correction (iMAR)" "is independent from the physical detector width"
DirectDensity Performance (iBHC variants)	Reduced dependence on tube voltage and filtration for non-water-like tissues. Image values aligned with material properties.	"reduced dependence on tube voltage and filtration compared to the corresponding quantitative kernel (Qr) with iBHC Bone for non-water-like tissues, such as adipose and bone." "generate image value closely aligned with the respective material properties." "has been validated."

2. Sample Sizes Used for the Test Set and Data Provenance

The document provides very limited, qualitative information:

FAST 3D Camera: Optimized using "additional data from adults and adolescence patients." No specific number of patients or images mentioned.
FAST Planning: Evaluated on "patient data." No specific number of patients or images mentioned.
HD FoV 5.0: Evaluated with "physical and anthropomorphic phantoms."
Flex 4D Spiral: No specific sample size or data type mentioned for performance assessment.
ZeeFree RT: Evaluated with "homogeneous water phantom," "phantom with tissue-equivalent inserts," "static torso phantom," and "dynamic thorax phantom." Also, "retrospective blinded rater studies of respiratory 4D CT examinations performed at two institutions." No specific number of phantoms, images per phantom, or patient cases mentioned.
DirectDensity: Evaluated on "SOMATOM CT scanner models." No specific sample size or data type mentioned.

Data Provenance:

Country of Origin: Not specified for the patient data used for algorithm optimization/validation.
Retrospective or Prospective:
- FAST 3D Camera: Implied retrospective as it uses "additional data."
- FAST Planning: Implied retrospective as it uses "patient data."
- HD FoV 5.0: Retrospective for the blinded rater study.
- ZeeFree RT: Retrospective for the blinded rater study of clinical cases. The phantom tests are by nature not retrospective/prospective.

3. Number of Experts and Qualifications for Ground Truth

HD FoV 5.0: "board-approved radio-oncologists and medical physicists." The number of experts is not specified.
ZeeFree RT: "board-approved radio-oncologists and medical physicists." The number of experts is not specified.

For other tests, ground truth appears to be established by phantom measurements or internal engineering verification, rather than human expert reads validating clinical ground truth.

4. Adjudication Method for the Test Set

The document mentions "retrospective blinded rater study" for HD FoV 5.0 and ZeeFree RT. However, it does not specify the adjudication method used (e.g., 2+1, 3+1, none) for these studies. It only states they were "blinded."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned for HD FoV 5.0 and ZeeFree RT. Both were "retrospective blinded rater studies."
Effect Size: The document does not report specific effect sizes (e.g., how much human readers improve with AI vs. without AI assistance). It only states that the purpose of the comparison was to "demonstrate that the HD FoV 5.0 algorithm is as safe and effective as the HD FoV 4.0 algorithm" and for ZeeFree RT that it "enables the optional reconstruction of stack artefact corrected images, which reduce the strength of misalignment artefacts." This implies an assessment of non-inferiority or improvement in image quality, but specific quantitative results for reader performance are not provided in this excerpt.

6. Standalone (Algorithm Only) Performance

The document describes tests for several algorithms (FAST 3D Camera, FAST Planning, HD FoV 5.0, Flex 4D Spiral, ZeeFree RT, DirectDensity) using phantoms and "patient data." These evaluations seem to be focused on the algorithm's performance in generating images or calculations, independent of human interpretation in some cases (e.g., accuracy of FAST 3D Camera, correctness percentage of FAST Planning).

However, it does not explicitly use the term "standalone performance" to differentiate these from human-in-the-loop assessments. The mention of "retrospective blinded rater studies" for HD FoV 5.0 and ZeeFree RT indicates a human-in-the-loop component for that specific evaluation, but the phantom testing mentioned alongside them would be considered standalone.

7. Type of Ground Truth Used

Phantom Data: For HD FoV 5.0, Flex 4D Spiral, ZeeFree RT, and DirectDensity, physical and/or anthropomorphic phantoms were used, implying the ground truth is precisely known physical characteristics or pre-defined phantom configurations.
Expert Consensus/Reads: For HD FoV 5.0 and ZeeFree RT, board-approved radio-oncologists and medical physicists performed retrospective blinded rater studies, implying their interpretations/ratings served as a form of ground truth or evaluation metric. It's not explicitly stated if this was against a clinical gold standard (e.g., pathology) or if it was a comparative assessment of image quality and clinical utility.
Internal Verification: For FAST 3D Camera, FAST Planning, accuracy was assessed, likely against internal system metrics or pre-defined ideal outcomes.

8. Sample Size for the Training Set

The document does not provide any specific information about the sample size used for training the algorithms (e.g., for FAST 3D Camera, FAST Planning, HD FoV 5.0, ZeeFree RT). It only states that FAST 3D Camera was "optimized using additional data" and FAST Planning's algorithm had "product development, validation, and verification on patient data."

9. How the Ground Truth for the Training Set Was Established

The document does not provide any specific information on how the ground truth for the training set was established. It only mentions the data types used for validation/verification (phantoms, patient data from two institutions, expert raters).

Summary

FDA 510(k) Clearance Letter - SOMATOM CT Systems

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov

July 3, 2025

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

Re: K250822
Trade/Device Name: SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed Tomography X-Ray System
Regulatory Class: Class II
Product Code: JAK
Dated: May 16, 2025
Received: June 16, 2025

Dear Kenny M Bello:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K250822 - Kenny M Bello Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K250822 - Kenny M Bello Page 3

assistance/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,

Lu Jiang

Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K250822

Device Name: SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse

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 staff as an aid in diagnosis, treatment, and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

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

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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."

FORM FDA 3881 (8/23) Page 1 of 1

Page 5

510(k) Summary

SOMATOM go. Platform and SOMATOM Pro.Pulse
with software version SOMARIS/10 syngo CT VB20

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

I. Contact Details

Submitter
Siemens Medical Solutions USA, Inc.
810 Innovation Drive
Knoxville, TN 37932
Establishment Registration Number: 1034973

Importer/Distributor
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Establishment Registration Number: 2240869

Location of Manufacturing Site (1)
Siemens Healthineers AG
Siemensstr. 1 -OR- Rittigfeld 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

Note: Descriptions in this submission use the short company name Siemens. It covers both manufacturing locations and names as listed above. Brand name on all products is Siemens Healthineers.

Term	Definition
modified	This feature is modified from the predicate devices
enabled	This feature is currently supported by other cleared Siemens CT systems or cleared Siemens stand-alone software applications. This feature will be supported for the subject device with software version SOMARIS/10 syngo CT VB20 and is substantially equivalent compared to the cleared version of the predicate devices.
unmodified	The feature remains unchanged from the predicate device.
n.a.	The feature is not supported for the subject/predicate device

Technological property	HW/SW change	Subject devices		Predicate devices
		Single Source	Dual Source	Single Source	Dual Source
		SOMATOM go. Platform with syngo CT VB20	SOMATOM Pro.Pulse with syngo CT VB20	SOMATOM go. Platform with syngo CT VB10 (K233650)	SOMATOM Pro.Pulse with syngo CT VB10 (K232206)
1. CARE Moodlight	HW/SW	enabled¹ (same as in K233650)	unmodified	cleared	cleared
2. Interfaces for respiratory gating	HW	modified² (same as in K233650, with exception of Open Online Interface which are introduced with syngo CT VB20)	n.a.	cleared	n.a.
3. Eco Power Mode	HW/SW	new³	new	n.a.	n.a.

Hardware property	Subject device SOMATOM go. Platform with SOMARIS/10 syngo CT VB20		Primary predicate device SOMATOM go. Platform with SOMARIS/10 syngo CT VB10 (K233650)
	SOMATOM go.Now	SOMATOM go.Up	SOMATOM go.Now	SOMATOM go.Up
scanner	Whole body Computed Tomography (CT) Scanner System	Whole body Computed Tomography (CT) Scanner System	Same as the primary predicate devices
System Configuration	Single Source	Single Source	Same as the primary predicate devices

Hardware property	Subject device SOMATOM go. Platform with SOMARIS/10 syngo CT VB20		Primary predicate device SOMATOM go. Platform with SOMARIS/10 syngo CT VB10 (K233650)		Assessment of the substantial equivalency (SE)
	SOMATOM go.All	SOMATOM go.Top	SOMATOM go.All	SOMATOM go.Top
scanner	Whole body Computed Tomography (CT) Scanner System	Whole body Computed Tomography (CT) Scanner System	Same as the primary predicate devices
System Configuration	Single Source	Single Source	Same as the primary predicate devices
Environment of Use	Professional Healthcare Facility	Professional Healthcare Facility	Same as the primary predicate devices
Generator Max. power (kW)	75	75	Same as the primary predicate devices
Detector technology	Stellar based on UFC (Ultra Fast Ceramic)	Stellar based on UFC (Ultra Fast Ceramic)	Same as the primary predicate devices
Detector volume coverage (mm)	22.4	38.4	22.4	38.4	Same as the primary predicate devices
Detector physical rows	32	64	32	64	Same as the primary predicate devices
Detector Slice width (mm)	0.7	0.6	0.7	0.6	Same as the primary predicate devices
Detector DAS channel no.	768	840	768	840	Same as the primary predicate devices

Hardware property	Subject device SOMATOM go. Platform with SOMARIS/10 syngo CT VB20		Primary predicate device SOMATOM go. Platform with SOMARIS/10 syngo CT VB10 (K233650)		Assessment of the substantial equivalency (SE)
	SOMATOM go.Sim	SOMATOM go.Open Pro	SOMATOM go.Sim	SOMATOM go.Open Pro
scanner	Whole body Computed Tomography (CT) Scanner System	Whole body Computed Tomography (CT) Scanner System	Same as the primary predicate devices
System Configuration	Single Source	Single Source	Same as the primary predicate devices
Environment of Use	Professional Healthcare Facility	Professional Healthcare Facility	Same as the primary predicate devices
Generator Max. power (kW)	75	75	Same as the primary predicate devices
Detector technology	Stellar based on UFC (Ultra Fast Ceramic)	Stellar based on UFC (Ultra Fast Ceramic)	Same as the primary predicate devices
Detector volume coverage (mm)	19.2	38.4	19.2	38.4	Same as the primary predicate devices
Detector physical rows	32	64	32	64	Same as the primary predicate devices
Detector Slice width (mm)	0.6	0.6	0.6	0.6	Same as the primary predicate devices

Hardware property	Subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20	Primary predicate device SOMATOM go.Top¹⁰ with SOMARIS/10 syngo CT VB10 (K233650)	Secondary predicate device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 (K232206)	Assessment of the substantial equivalency (SE)
Detector Slice width	0.6 mm	0.6 mm	0.6 mm	Same as the primary and secondary predicate device
Detector DAS channel no.	840 (detector A) 600 (detector B)	840	840 (detector A) 600 (detector B)	Same as the secondary predicate device
Detector Image slices	2 x 128 (with Interleaved Volume Reconstruction, IVR) 2 x 384 (reconstructed slices)	128 (with Interleaved Volume Reconstruction, IVR) 384 (reconstructed slices)	2 x 128 (with Interleaved Volume Reconstruction, IVR) 2 x 384 (reconstructed slices)	Same as the secondary predicate device
Tube technology	2 x Athlon DS X-ray tube	Athlon X-ray tube	2 x Athlon DS X-ray tube	Same as the secondary predicate device.
Tube collimator	Tube collimator DS4-A, DS4-B • Equivalent to 0.5 mm Al in the isocenter • 1 mm Al with cardio wedge	Tube collimator • Equivalent to 0.5 mm Al in the isocenter • 1 mm Al with cardio wedge	Tube collimator DS4-A, DS4-B • Equivalent to 0.5 mm Al in the isocenter • 1 mm Al with cardio wedge	Same as the secondary predicate device.
Tube kV steps	70–140 kV in 10 kV steps	70–140 kV in 10 kV steps	70–140 kV in 10 kV steps	Same as the primary and the secondary predicate device
Tube Max. current	Single Source: 13-825 mA Dual Source: 26-1650 mA	Standard range: 13 – 825 mA	Single Source: 13-825 mA Dual Source: 26-1650 mA	Same as the secondary predicate device.

Hardware property	Subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20	Primary predicate device SOMATOM go.Top¹⁰ with SOMARIS/10 syngo CT VB10 (K233650)	Secondary predicate device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 (K232206)	Assessment of the substantial equivalency (SE)
Tube focus	• 0.8 × 0.8 / 7° • 1.0 × 1.2 / 7°	• 0.8 × 0.8 / 7° • 1.0 × 1.2 / 7°	• 0.8 × 0.8 / 7° • 1.0 × 1.2 / 7°	Same as the primary and the secondary predicate device.
Tube Heat storage capacity	2 x 7.0 MHU	7.0 MHU	2 x 7.0 MHU	Same as the primary and the secondary predicate device.
Tube Cooling rate (MHU/ min)	up to 1.7	up to 1.7	up to 1.7	Same as the primary and the secondary predicate device.
Gantry Bore size	70	70	70	Same as the primary and the secondary predicate device
Gantry Scan FoV (cm)	50	50	50	Same as the primary and the secondary predicate device
Gantry Extended FoV (cm)	70	70	70	Same as the primary and the secondary predicate device
Gantry Rot. time (sec)	0.33 (optional), 0.5, 1.0	0.33 (optional), 0.5, 1.0	0.33 (optional), 0.5, 1.0	Same as the primary and the secondary predicate device
Gantry Tilt (degree)	n.a.	± 30°	n.a.	Same as the secondary predicate device.
Maximum temporal resolution in ECG gated or triggered examination (ms)	86 ms (mono-segment) 43 ms (bi-segment)	165 ms (mono-segment) 82.5 ms (bi-segment)	86 ms (mono-segment) 43 ms (bi-segment)	Same as the secondary predicate device

Hardware property	Subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20	Primary predicate device SOMATOM go.Top¹⁰ with SOMARIS/10 syngo CT VB10 (K233650)	Secondary predicate device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 (K232206)	Assessment of the substantial equivalency (SE)
Maximum scan speed at pitch (mm/s at pitch x)	372 mm/s at pitch 3.2	175 mm/s at pitch 1.5	372 mm/s at pitch 3.2	Same as the secondary predicate device
Patient table Type	Vario 2 (2000 mm) Vario 2.D (2000 mm)	Vario1 (1600 mm) Vario RT (1600 mm) Vario 2 (2000mm)	Vario 2 (2000 mm) Vario 2.D (2000 mm)	Same as the secondary predicate device.
Patient table Max. weight capacity (kg)	307	227 307	307	Same as the secondary predicate device.
Max. scan length topogram	2080 mm with table extension	1680 mm with table extension 2080 mm with table extension	2080 mm with table extension	Same as the secondary predicate device.
Max. scan length Image acquisition	Max. 2000 mm with patient table extension	Max. 1600 mm with patient table extension Max. 2000 mm with patient table extension	Max. 2000 mm with patient table extension	Same as the secondary predicate device.

Hardware property	Subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20	Primary predicate device SOMATOM go.Top¹⁰ with SOMARIS/10 syngo CT VB10 (K233650)	Secondary predicate device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 (K232206)	Assessment of the substantial equivalency (SE)
Spectral filtration	Tin Filter	Combined Tin Filter / Split Filter	Tin Filter	Same as the secondary predicate device
FAST 3D Camera	option for patient positioning with FAST 3D Camera: • Ceiling mounted • Gantry mounted	option for patient positioning with FAST 3D Camera: • ceiling mounted • gantry mounted	option for patient positioning with FAST 3D Camera: • Ceiling mounted • Gantry mounted	Same as the primary and the secondary predicate device
High Power 70/ High Power 80	up to 825 mA (@70 kV)/ up to 825 mA (@80 kV)	up to 825 mA (@70 kV)/ up to 825 mA (@80 kV)	up to 825 mA (@70 kV)/ up to 825 mA (@80 kV)	Same as the primary and the secondary predicate device
x-ray foot switch	Option to trigger hands-free scanning	Option to trigger hands-free scanning	Option to trigger hands-free scanning	Same as primary and the secondary predicate device
Table foot switch	Option for table patient movement	Option for table patient movement	Option for table patient movement	Same as the primary and the secondary predicate device
i-joystick	Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted.	Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted.	Option for patient table movements, including an electrical connection for the tablet dock which allows charging the tablet when mounted.	Same as the primary and the secondary predicate device
Tablet dock	Option for mounting of the tablet on the patient table.	Option for mounting of the tablet on the patient table.	Option for mounting of the tablet on the patient table.	Same as the primary and the secondary predicate device

Hardware property	Subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20	Primary predicate device SOMATOM go.Top¹⁰ with SOMARIS/10 syngo CT VB10 (K233650)	Secondary predicate device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 (K232206)	Assessment of the substantial equivalency (SE)
CARE 2D camera	one integrated into the gantry front and one mounted on the gantry back to monitor the patient during examination	one integrated into the gantry front and one mounted on the gantry back to monitor the patient during examination	one integrated into the gantry front and one mounted on the gantry back to monitor the patient during examination	Same as the primary and the secondary predicate device
CARE Moodlight	LED lights integrated on the gantry front cover indicating: • System startup • Scan countdown • Scan	LED lights integrated on the gantry front cover indicating: • System startup • Scan countdown • Radiation on	LED lights integrated on the gantry front cover indicating: • System startup • Scan countdown • Radiation on	Same as the primary and the secondary predicate device. In the subject device with syngo CT VB20, the status "Radiation on" has been renamed to "Scan".
Moodlight	• Gantry ring Moodlight: ambient light during examination. • CARE Funnel Light: ambient light which illuminates the gantry funnel	• Gantry ring Moodlight: ambient light during examination.	• Gantry ring Moodlight: ambient light during examination. • CARE Funnel Light: ambient light which illuminates the gantry funnel	Same as the secondary predicate device

Software property	Subject device with SOMARIS/10 syngo CT VB20		Primary predicate device with SOMARIS/10 syngo CT VB10 (K233650)	Secondary predicate device with SOMARIS/10 syngo CT VB10 (K232206)	Assessment of the substantial equivalency (SE)
	SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro	SOMATOM Pro.Pulse	SOMATOM go.Now SOMATOM go.Up SOMATOM go All SOMATOM go.Top SOMATOM go.Sim SOMATOM go.Open Pro	SOMATOM Pro.Pulse
	• Protocol supporting contrast bolus-triggered data acquisition • Contrast media protocols (including coronary CTA) • Pediatric Protocols • Flex Dose Profile • Turbo Flash Spiral • Dual Energy acquisition (TwinBeam DE and TwinSpiral DE) • Dynamic imaging (Flex 4D Spiral)	• Contrast media protocols (including coronary CTA) • Pediatric Protocols • Flex Dose Profile • Dynamic imaging (Flex 4D Spiral) • interventional scan protocols (scan modes: i-sequence, i-spiral, i-Fluoro) • Protocols supporting Cardiac Scanning, Spectral imaging for child examination, Spectral imaging with high resolution	• Protocol supporting contrast bolus-triggered data acquisition • Contrast media protocols (including coronary CTA) • Pediatric Protocols • Flex Dose Profile • Turbo Flash Spiral • Dual Energy acquisition (TwinBeam DE and TwinSpiral DE) • Dynamic imaging (Flex 4D Spiral)	• Contrast media protocols (including coronary CTA) • Pediatric Protocols • Flex Dose Profile • Dynamic imaging (Flex 4D Spiral) • interventional scan protocols (scan modes: i-sequence, i-spiral, i-Fluoro) • Protocols supporting Cardiac Scanning, Spectral imaging for child examination, Spectral imaging with high resolution	Same as the secondary predicate device

Feature/Non-clinical supportive testing	Bench Testing performed
	Overall, the subject devices with syngo CT VB20 delivers comparable or improved accuracy to the predicate devices with syngo CT VB10 predicate device for adults and extends the support to adolescents.
FAST Planning	The purpose of the test is to provide a clear reporting on the applied algorithm, its product development, validation, and verification on patient data, which enable the claims. Objective of the test is to assess the fraction (percentage) of ranges calculated by the FAST Planning algorithm that are correct and can be applied without change. Additionally, calculation time was measured to check whether it meets interactive requirements. The test results show that the editing actions for the scanner technician can be reduced to a minimum and that the calculation time is fast enough for interactive speed during scanning. For more than 90% of the ranges no editing action was necessary to cover standard ranges. For more than 95%, the speed of the algorithm was sufficient.
HD FoV 5.0	The bench test contains a detailed description and evaluation of the new HD FoV 5. 0 algorithm for extended field of view reconstruction. Results obtained with the new HD FoV 5. 0 algorithm are compared with its predecessor, the HD FoV 4. 0 algorithm, based on physical and anthropomorphic phantoms. In addition to the bench test, the performance of the algorithm was evaluated by board-approved radio-oncologists and medical physicists by means of retrospective blinded rater study. This comparison is conducted to demonstrate that the HD FoV 5. 0 algorithm is as safe and effective as the HD FoV 4. 0 algorithm.
Flex 4D Spiral	The performed bench test report describes the technical background of Flex 4D Spiral and its functionalities with SOMATOM CT scanners, demonstrate the proper function of those, and assess the image quality of Flex 4D Spiral.
ZeeFree RT	The bench test evaluates the performance of the ZeeFree RT reconstruction. The objectives of the tests are to demonstrate that compared to the Standard reconstruction, ZeeFree RT • introduces no relevant errors in terms of CT values and noise levels measured in a homogeneous water phantom, and • introduces no relevant errors in terms of CT values measured in a phantom with tissue-equivalent inserts, even in the presence of metals and in combination with the iMAR algorithm, and • introduces no relevant geometrical distortions in a static torso phantom, and

Date of Entry	Recognition Number	Standard Developing Organization	Standard Designation Number and Date	Title of Standard
12/18/2023	12-352	NEMA	PS 3.1 - 3.20 2023e	Digital Imaging and Communications in Medicine (DICOM) Set
07/06/2020	12-325	NEMA	XR 25-2019	Computed Tomography Dose Check
07/06/2020	12-330	NEMA	XR 28-2018	Supplemental Requirements for User Information and System Function Related to Dose in CT
12/23/2019	12-328	IEC	61223-3-5 Edition 2.0 2019-09	Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests and constancy tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
03/14/2011	12-226	IEC	61223-2-6 Second Edition 2006-11	Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
06/07/2021	12-336	IEC	60601-1-3 Edition 2.2 2021-01 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment
06/27/2016	12-302	IEC	60601-2-44 Edition 3.2: 2016	Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and

Date of Entry	Recognition Number	Standard Developing Organization	Standard Designation Number and Date	Title of Standard
				essential performance of x-ray equipment for computed tomography
12/23/2019	5-125	ANSI AAMI ISO	14971: 2019	Medical devices - Applications of risk management to medical devices
			ISO 14971 Third Edition 2019-12	Medical devices - Application of risk management to medical devices
01/14/2019	13-79	ANSI AAMI IEC	62304:2006/A1:2016	Medical device software - Software life cycle processes [Including Amendment 1 (2016)]
			IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION	Medical device software - Software life cycle processes
05/30/2022	19-46	ANSI AAMI	ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
12/21/2020	19-36	ANSI AAMI IEC	60601-1-2:2014 [Including AMD 1:2021]	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
			IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Date of Entry	Recognition Number	Standard Developing Organization	Standard Designation Number and Date	Title of Standard
07/06/2020	5-129	ANSI AAMI IEC	62366-1:2015+AMD1:2020 (Consolidated Text)	Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
			IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION	Medical devices - Part 1: Application of usability engineering to medical devices
07/09/2014	12-273	IEC	60825-1 Edition 2.0 2007-03	Safety of laser products - Part 1: Equipment classification, and requirements
12/21/2020	5-132	IEC	60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
12/23/2019	12-309	IEC	60601-2-28 Edition 3.0 2017-06	Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
12/20/2021	12-341	IEC	62563-1 Edition 1.2 2021-07 CONSOLIDATED VERSION	Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods

Standard Developing Organization	Standard Designation Number and Date	Title of Standard	How was Standard Used
			A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
IEC/ISO	17050-1	Conformity Assessment – Supplier's declaration of conformity – Part 1: General requirements	Declaration of conformance to FDA recognized consensus standards.
IEC/ISO	17050-2	Conformity assessment – Supplier's declaration of conformity – Part 2: Supporting documentation.	General consensus standards not currently recognized by FDA.

FDA Guidance Document	Issue date
User Fees and Refunds for Premarket Notification Submissions (510(k)s): Guidance for Industry and Food and Drug Administration Staff	10/05/2022
Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff	04/21/2022
Electronic Submission Template for Medical Device 510(k) Submissions	10/2/2023
Deciding When to Submit a 510(k) for a Change to an Existing Device	10/25/2017
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]	07/28/2014
Content of Premarket Submissions for Software Contained in Medical Devices	06/14/2023
Off-The-Shelf Software Use in Medical Devices	09/27/2019
Applying Human Factors and Usability Engineering to Medical Devices	02/03/2016
Pediatric Information for X-ray Imaging Device Premarket Notifications	11/28/2017
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions	09/27/2023
Electromagnetic Compatibility (EMC) of Medical Devices	06/06/2022
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices	09/06/2017

Understanding the Device and its Changes

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

3. Number of Experts and Qualifications for Ground Truth

4. Adjudication Method for the Test Set

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

6. Standalone (Algorithm Only) Performance

7. Type of Ground Truth Used

8. Sample Size for the Training Set

9. How the Ground Truth for the Training Set Was Established

FDA 510(k) Clearance Letter - SOMATOM CT Systems

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Indications for Use

Indications for Use (Describe)

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

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510(k) Summary

I. Contact Details

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II. Device Name and Classification

III. Predicate Device

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IV. Device Description

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V. Indications for Use

VI. Indications for Use Comparison

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VII. Comparison of Technological Characteristics with the Predicate Device

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