This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.

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

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Scan&GO:

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

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

Device Description

The subject device SOMATOM go.Platform with SOMARIS/10 syngo CT VA30 are Computed Tomography Xray Systems which feature one continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go.Platform with Software SOMARIS/10 syngo CT VA30 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.

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

AI/ML Overview

The provided text describes acceptance criteria and testing for the Siemens SOMATOM go.Platform CT Scanners with software version SOMARIS/10 syngo CT VA30, and the Scan&GO mobile medical application.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document details various non-clinical tests conducted, with statements of the test results meeting the acceptance criteria. However, it does not present a single consolidated table of specific, quantifiable acceptance criteria alongside reported performance values for those criteria. Instead, it offers narrative summaries of the testing and its outcomes, indicating successful verification and validation.

Below is a table constructed from the provided text, outlining the features tested and the reported performance (which is generally stated as "met acceptance criteria" or "similar/improved performance").

Feature/Test	Acceptance Criteria (Implicit)	Reported Device Performance
Non-Clinical Performance Testing:
kV and Filter independent CaScore	Performance of special kernel variants Artifical120 and eDDensity and mDDensity similar or improved within accuracy limits compared to initial release versions.	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 compared 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.
Recon&GO - Spectral Recon	Deviations between cleared image processing algorithms in Inline DE and new realization "Spectral Recon" should be extremely small and not impact diagnostic performance.	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.
TwinSpiral Dual Energy / TwinSpiral DE	Provide CT-images of diagnostic quality, similar to conventional 120kV images in terms of CT-values and image noise at same radiation dose. Iodine CNR at same radiation dose comparable between Mixed images and 120kV images.	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.
Flex 4D Spiral - Neuro/Body	Scanned volume in agreement with planned scan range; irradiated range markers in agreement with exposed area on film.	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. 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.
DirectDensity	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.
HD FoV	Provide visualization of anatomies outside the standard field of view; image quality standards for radiotherapy applications met.	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.
Contrast media protocol	All Factory Contrast Protocols within limits prescribed by approved labeling of Ultravist®.	All Factory Contrast Protocols are within the limits as prescribed by the approved labeling of Ultravist®. (no protocol for coronary CTA)
InjectorCoupling	Correctness of contrast injection parameters transferred between CT device and supported injection devices verified.	Correctness of the contrast injection parameters transferred between the CT device and the supported injection devices has been verified.
Direct i4D	Ability to acquire data for a full breathing cycle at every position even if respiratory rate changes, avoiding interpolation artifacts compared to conventional 4DCT.	The test results show that with Direct i4D it is possible to acquire data for a full breathing cycle at every position of the patient even if the respiratory rate changes during the data acquisition. Compared to the conventional 4DCT scan mode interpolation artifacts (which occur because not for every position a complete breathing cycle could be acquired) can successfully be avoided with Direct i4D.
Check&GO	Helpful in aiding user to reduce instances where image quality may be compromised (for metal detection and contrast determination).	The "Check&GO feature can be proven helpful in aiding the user to reduce instances where the image quality may be compromised." (For metal detection and automatic contrast state determination).
Siemens Direct Laser (RTP Laser)	Unit tested against general requirements, mechanics, connectors, function requirements, and integral light markers (IEC 60601-2-44).	RTP-Laser Electronics - Test specification (Unit) Version 00 and Report - General Requirements - Mechanics, Connectors - Function requirements Attachment 12 to Report CN19-003-AU01-S01-TR31 - Test for the new RTP Laser Unit 10830876 - Integral Light Markers For Patient Marking (IEC 60601-2-44) were successfully demonstrated.
Wireless Coexistence Testing	Safe operation of wireless components in combination with applicable system functionality, ensuring coexistence with other devices.	Testing for co-existence considered for following scenarios: Co-Channel Testing, Adjacent Channel Testing, RF Interference Testing, Separation Distance/Location Testing. Scan&GO is designed to allow dynamic frequency selection and transmission power control by default in accordance with IEEE 802.11h. Adjacent channel testing is addressed by the fact that Scan&GO does not support shared medium access to Siemens Wi-Fi network. RF interference was tested by successfully ensuring that wireless communications were actively transmitting in situations where possible interference may exist. Recommended distance and router locations requirements are documented in the user documentation.
System Test (Workflow, User Manual, Legal/Regulatory)	All acceptance criteria defined for these tests must be met.	All tests performed meet the pre-determined acceptance criteria.
System Integration Test (Functional, Image Quality, DICOM)	All acceptance criteria defined for these tests must be met.	All tests performed meet the pre-determined acceptance criteria.
Subsystem Integration Test (Functional, DICOM)	All acceptance criteria defined for these tests must be met.	All tests performed meet the pre-determined acceptance criteria.

2. Sample size used for the test set and the data provenance

Check&GO Testing:
- Sample size: 500 CT-series from 100 patients.
- Data provenance: Not explicitly stated, but clinical datasets were used ("clinical datasets from 100 patients"). It's specified as a "bench test," which implies it was likely retrospective from an existing data archive. Country of origin is not mentioned.
Other Non-Clinical Testing (Phantom, Integration, Functional): The document frequently refers to "phantom images," "test levels," "development activities," and "bench tests." No specific sample sizes for these tests (e.g., number of phantom scans) or data provenance are provided beyond the general descriptions of the tests themselves, which are stated as having been conducted "during product development."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Check&GO Testing:
- Ground Truth Establishment: The datasets were "manually annotated with a detailed GT contrast-state (None, Low, InhomogeneousLow, Standard, InhomogeneousHigh, High)."
- Number & Qualifications of Experts: Not specified.
Other Tests: For other tests, such as those involving image quality or physical measurements (e.g., Flex 4D Spiral, DirectDensity), the ground truth is typically derived from physical measurements, reference standards (e.g., known phantom properties), or established technical specifications, rather than expert consensus on clinical interpretation. The document does not mention the use of experts to establish ground truth for these tests. The indication for the new "Kidney Stones" feature notes: "Only a well-trained radiologist can make the final diagnosis under consideration of all available information," suggesting the involvement of radiologists in the clinical context, but not for ground truth establishment specifically for the device's technical validation.

4. Adjudication method for the test set

The document does not explicitly describe an adjudication method (like 2+1, 3+1, etc.) for any of the test sets. For the Check&GO test, ground truth was "manually annotated," implying a single process for ground truth establishment rather than a consensus/adjudication method among multiple experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study involving human readers and AI assistance is reported for this device in the provided text. The device itself is a CT scanner system and its associated software, not explicitly an AI-assisted diagnostic tool for interpretation in collaboration with human readers. The Check&GO feature is described as "aiding the user," but no study on human performance improvement is included.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The non-clinical performance testing, particularly phantom studies and specific feature evaluations like "kV and Filter independent CaScore," "Recon&GO - Spectral Recon," "TwinSpiral Dual Energy," "Flex 4D Spiral," "DirectDensity," "HD FoV," and "InjectorCoupling," can be considered standalone algorithm/device performance evaluations. These tests assess the technical output and accuracy of the device and its software features independent of human interpretation or interaction during the measurement process. The Check&GO feature's "Bench Test" also evaluates the algorithm's performance against annotated ground truth.

7. The type of ground truth used

Check&GO: Expert annotation of "detailed GT contrast-state" (None, Low, InhomogeneousLow, Standard, InhomogeneousHigh, High) for 500 CT series.
Other Feature Tests (e.g., CaScore, Spectral Recon, Flex 4D Spiral, DirectDensity, HD FoV, TwinSpiral DE): Primarily derived from physical phantom measurements, comparison to established technical specifications, or reference images/algorithms (e.g., comparing to initial release versions or conventional 120kV images).
National Lung Screening Trial (NLST): Outcomes data from a large clinical trial (N Engl J Med 2011; 365:395-409) is cited to support the "low dose lung cancer screening" indication for use, not for direct ground truth establishment during this device's specific validation, but rather as supportive clinical literature for the screening concept itself.

8. The sample size for the training set

The document does not specify any training set sizes. The studies described are primarily for verification and validation, not for training machine learning models. The Check&GO feature describes "500 CT-series from 100 patients were used for the testing of the algorithm," but this is explicitly called "testing," not training.

9. How the ground truth for the training set was established

Since no training set details (size or establishment method) are provided, this information is not available in the document.

Summary

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

November 21, 2019

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

Re: K192061

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

Dear Alaine Medio:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

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

Enclosure

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Indications for Use

510(k) Number (if known) K192061

Device Name

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

Indications for Use (Describe)

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

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)

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Indications for Use

510(k) Number (if known) K192061

Device Name Scan & GO

Indications for Use (Describe)

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

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)
------------------------------------------------------------	-----------------------------------------------------------

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K192061

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

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

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

I. Submitter

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

Importer/Distributor

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

Location of Manufacturing Site (1)

Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335

Location of Manufacturing Site (2)

SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Registration Number: 3003202425

Contact Person:

Alaine Medio, RAC Regulatory Affairs Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 (865) 206-0337 (work cell) (865) 218-3019 FAX alaine.medio@siemens-healthineers.com

II. Device Name and Classification

Product Name:	SOMATOM go.Now, SOMATOM go.Up,SOMATOM go.All, SOMATOM go.Top,SOMATOM go.Sim, SOMATOM go.Open Pro
Trade Name:	SOMATOM go.Now, SOMATOM go.Up,SOMATOM go.All, SOMATOM go.Top,SOMATOM go.Sim, SOMATOM go.Open Pro

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

Primary Predicate Device: Trade Name:

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

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

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

Predicate Device:
Trade Name:	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOMDefinition 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.

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IV. Device Description

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

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

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

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

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

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

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

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1) New/Modified Hardware

Table S01: Overview of Hardware modifications ●

Software version SOMARIS/10 syngo CT VA30 2)

Table S02: Overview Software modifications of SOMATOM go.Platform with syngo CT VA30 ●
The configuration table and comparison table use the following Terms to describe various technological characteristics in comparison to the predicate device information:

Term	Definition
N/A	The feature is not supported for the subject device
New	The feature is newly supported for Siemens CT Scanners and the subject device
Modified	This feature is modified from the previously cleared version
Unmodified	This feature remains unchanged from the predicate device
Enabled	This feature is currently supported by other cleared Siemens CT systems. This feature will be supported for the subject device with software version SOMARIS/10 syngo CT VA30 and the feature is unmodified from the cleared version.

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

#	hardware properties	Subject DevicesSOMATOM go.Now	Subject DevicesSOMATOM go.Up	Subject DevicesSOMATOM go.All	Subject DevicesSOMATOM go.Top	Subject DevicesSOMATOM go.Sim	Subject DevicesSOMATOM go.Open Pro
1	PatientObservationCamera	Unmodified	Unmodified	Unmodified	Unmodified	Modified	Modified
2	Moodlight	Unmodified	Unmodified	Unmodified	Unmodified	Modified	Modified
3	Various TabletConfiguration	Modified	Modified	Modified	Modified	Modified	Modified
4	High Power 70 /High Power 80	Unmodified	Unmodified	Unmodified	Unmodified	Enabled	Enabled
5	Adaptive DoseShield	N/A	N/A	N/A	Enabled	N/A	Enabled
6	Tin Filter	Unmodified	Unmodified	Unmodified	Unmodified	Enabled	Enabled
7	Split Filter	N/A	N/A	N/A	Unmodified	N/A	Enabled
8	Integrated PatientMarking –Direct Laser	N/A	N/A	N/A	N/A	New	New
9	Other hardwaremodifications(e.g. new largebore size andFoV)	N/A	N/A	N/A	N/A	Modified	Modified

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

	SOMATOM CTSystem ScannerwithSOMARIS/10syngo CT VA30	SubjectDevices	SubjectDevices	SubjectDevices	SubjectDevices	SubjectDevices	SubjectDevices	SubjectDevices
	Softwareproperties	SOMATOMgo.Now	SOMATOMgo.Up	SOMATOMgo.All	SOMATOMgo.Top	SOMATOMgo.Sim	SOMATOMgo.Open Pro	Scan&GO
1	MPPS	Enabled	Enabled	Enabled	Enabled	Enabled	Enabled	N/A
2	Flex Dose Profile	Modified	Modified	Modified	Modified	Modified	Modified	N/A
3	Flex 4D Spiral	N/A	N/A	Modified	Modified	Modified	Modified	N/A
4	DirectDensity™	Enabled	Enabled	Enabled	Enabled	Enabled	Enabled	N/A
5	Scan&GO -Mobile workflow	Modified	Modified	Modified	Modified	Modified	Modified	Modified
6	CT View&GO -Advanced tools	Modified	Modified	Modified	Modified	Modified	Modified	N/A

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	SOMATOM CTSystem ScannerwithSOMARIS/10syngo CT VA30	SubjectDevices	SubjectDevices	SubjectDevices	SubjectDevices	SubjectDevices	SubjectDevices	SubjectDevices
	Softwareproperties	SOMATOMgo.Now	SOMATOMgo.Up	SOMATOMgo.All	SOMATOMgo.Top	SOMATOMgo.Sim	SOMATOMgo.Open Pro	Scan&GO
7	Check&GO - MetalDetection	New	New	New	New	New	New	New
8	CARE Contrast IIIand Contrast mediaprotocol	Modified	Modified	Modified	Modified	Modified	Modified	N/A
9	CARE kV	N/A	N/A	Modified	Modified	Modified	Modified	N/A
10	kV and FilterindependentCaScore(Artificial120)	N/A	Enabled	Enabled	Enabled	Enabled	Enabled	N/A
11	Recon&GO -AdvancedReconstruction	Modified	Modified	Modified	Modified	Modified	Modified	N/A
12	Recon&GO - Post-Processing plug infunctions	Modified	Modified	Modified	Modified	Modified	Modified	N/A
13	TwinBeam DualEnergy	N/A	N/A	N/A	Modified	N/A	Modified	N/A
14	TwinSpiral DualEnergy / TwinSpiralDE	Modified	Modified	Modified	Modified	Modified	Modified	N/A
15	FAST Planning.FAST Window	Modified	Modified	Modified	Modified	Modified	Modified	N/A
16	HD FoV 4.0	Enabled	Enabled	Enabled	Enabled	Enabled	Enabled	N/A
17	Imaging - Examworkflow	New	New	New	New	New	New	New
18	Imaging - CardioBestPhase	N/A	Enabled	Enabled	Enabled	Enabled	Enabled	N/A
19	Multistudy	Modified	Modified	Modified	Modified	Modified	Modified	N/A
20	Multiphase	N/A	N/A	Modified	Modified	Modified	Modified	N/A
21	Respiratory MotionManagement	Enabled	Enabled	Enabled	Enabled	Enabled	Enabled	N/A
22	Patient Marking -Direct LaserSteering	New	New	New	New	New	New	New
23	Direct i4D	N/A	N/A	N/A	N/A	N/A	New	N/A

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

V. Indications for Use

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

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:

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VI. Comparison of Technological Characteristics with the Predicate Device

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

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

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

At a high level, the subject and predicate devices are based on the following same technological elements:

Scanner Principle- Whole body X-Ray Computed Tomography Scanner ●
System Acquisition Continuously rotating tube detector system ●
Iterative Reconstruction Support of various iterative reconstruction methods ●
Workplaces Support of workplaces that include reconstruction and image evaluation software ●
. Patient table
Patient table foot switch for movement
Tin filtration technology
Chronon, Athlon or Vectron X-ray Tube
Stellar detector technology
. Maximum power Generator
High Power 70, High Power 80 (High mA@low kV)
. Iterative Reconstruction Methods
. Mobile Medical application Software functionality (Scan&GO)
Mobile workflow (Tablet)
. Scanner display and control functionality
Remote Scan Control
Support of Intervention Workflow - Guide&GO
Optional Injector Arm
Long scan range
DirectDensity™ Reconstruction, which provides CT images with an HU-like scaling that is nearly . proportional to relative electron density or relative mass density
. Respiratory Scan - Functions

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

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

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

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

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

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

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

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

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	Table S03: SOMATOM go.Platform comparable hardware propertiesSOMATOM go.Platform - Device Comparison (Single Source Systems)
HardwareProperty	SOMATOMgo.Now	SOMATOMgo.Up	SOMATOMgo.All	SOMATOMgo.Top	SOMATOMgo.Sim	SOMATOMgo.Open Pro	PrimaryPrediacteDeviceSOMATOMgo.Top(K173632)
Scanner	whole body X-ray computed tomography scanner
Generatormax. power	32 kW	32 kW	75 kW	75 kW	75 kW	75 kW	75 kW
Detectortechnology	Stellar	Stellar	Stellar	Stellar	Stellar	Stellar	Stellar
Detectorvolumencoverage	11.2 mm	22.4 mm	22.4 mm	38.4 mm	19.2 mm	38.4 mm	38.4 mm
Detectorphysical rows	16	32	32	64	32	64	64
Detectorslice width	0.7 mm	0.7 mm	0.7 mm	0.6 mm	0.6 mm	0.6 mm	0.6 mm
DetectorDAS channelNo.	768	768	768	840	920	920	840
Detectorimage slices	32	64	64	128	64	128	128
TubeTechnologie	Chronon	Chronon	Athlon	Athlon	Athlon	Athlon	Athlon
TubekV steps		(in 20kV steps)80 kV to 130kV			(in 10kV steps)70 kV to 140 kV
Tubemax. current	400 mA	400 mA	825 mA	825 mA	825 mA	825 mA	825 mA
Tubetube focus	0.8 x 0.40.8 x 0.7	0.8 x 0.40.8 x 0.7	1.0 x 1.20.8 x 0.8	1.0 x 1.20.8 x 0.8	1.0 x 1.20.8 x 0.8	1.0 x 1.20.8 x 0.8	1.0 x 1.20.8 x 0.8
Tubeheat capacity	3.5 MHU	3.5 MHU	6 MHU	6 MHU	6 MHU	6 MHU	6 MHU
Gantrybore size	70 cm	70 cm	70 cm	70 cm	85 cm	85 cm	70 cm
GantryFoV	50 cm	50 cm	50 cm	50 cm	60 cm	60 cm	50 cm
Gantryrotation time(sec)	0.8, 1.0, 1.5		0.33, 0.5, 1.0		0.35, 0.5, 1.0		0.33, 0.5, 1.0
GantryTilt [degrees]	N/A	+/-25	+/-25	+/-25	+/-25	+/-25	+/-25
Patient Tabletype	Vector:1.250 mVario 1 andVario RT:1.600 m withtableextension	Vario 1 (1.600 m, Vario 2 (2.000m and VarioRT: 1.600 m with table extension			Vario 2 (2.000m and VarioRT: 1.600 m with tableextension		Vario 1(1.600 m,Vario 2(2.000m andVario RT:1.600 m withtableextension
Max. ScanlengthTopogram	1680 mm	1680 mm2080 mm	1680 mm2080 mm	1680 mm2080 mm	1680 mm2080 mm	1680 mm2080 mm	1680 mm2080 mm
Max. ScanlengthImageacquisition	1600 mm	1600 mm,2000 mm	1600 mm,2000 mm	1600 mm,2000 mm	1600 mm,2000 mm	1600 mm,2000 mm	1600 mm,2000 mm
Spectralfiltrationoption	Tin Filtersupported	Tin Filtersupported	Tin Filtersupported	CombinedSplitFilter/TinFilter	Tin Filtersupported	CombinedSplitFilter/TinFilter	CombinedSplitFilter/TinFilter
High Power 70	N/A	N/A	825 mA(@ 70 kV)	825 mA(@ 70 kV)	825 mA(@ 70 kV)	825 mA(@ 70 kV)	825 mA(@ 70 kV)
High Power 80	N/A	N/A	825 mA(@ 70 kV)	825 mA(@ 70 kV)	825 mA(@ 70 kV)	825 mA(@ 70 kV)	825 mA(@ 70 kV)

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

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

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	Subject Device	Primary Predicate Device	Predicate Device
	SOMATOM go.Now,●	SOMATOM go.Now,●	SOMATOM Edge Plus
	SOMATOM go.Up,●	SOMATOM go.Up,●
Propertiessoftware	SOMATOM go.All,●	SOMATOM go.All,●
	SOMATOM go.Top,●	SOMATOM go.Top ●
	SOMATOM go.Sim,●
	SOMATOM go.Open Pro(syngo CT VA30)
		(K173632)	(K190578)
OperatingSystem	Windows basedSOMARIS/10 syngo CT VA30	Windows basedSOMARIS/10 syngo CT VA20A	Windows basedSOMARIS/7 syngo CT VB20
	syngo Acquisition Workplace(AWP)	syngo Acquisition Workplace(AWP)	syngo Acquisition Workplace(AWP)
AcquisitionWorkplace	syngo Viewing, syngo Filmingand syngo Archiving &Networking	syngo Viewing, syngo Filmingand syngo Archiving &Networking	syngo Viewing, syngo Filmingand syngo Archiving &Networking
	Image Reconstruction	Image Reconstruction	Image Reconstruction
Stellar Detector	Stellar detector firmwaresupported	Stellar detector firmwaresupported	Stellar detector firmwaresupported
Teamplay	Support teamplay Protocols	Support teamplay Protocols	Support teamplay Protocols
	Support of:● Protocols for RadiationTherapy Planning supportpatient marking● Protocols that allow scanningwith support of an externalrespiratory gating system(ANZAI, Varian RGSC)● Protocol supporting contrastbolus-triggered dataacquisition● Contrast media protocols● Pediatric Protocols● Flex Dose Profile● TwinBeam DE● TwinSpiral DE● Flex 4D Spiral	Support of:● Protocols for RadiationTherapy Planning● Protocol supporting contrastbolus-triggered dataacquisition● Pediatric Protocols	Support of :● Protocols for RadiationTherapy Planning● Protocols for RadiationTherapy Planning● Protocols that allowtriggering of breath holdscanning from externaldevice.● Protocol supporting contrastbolus-triggered dataacquisition● Pediatric Protocols● Adaptive Dose Area● DualSource DE● Adaptive 4D Spiral
Protocols


	enabled via software interface	enabled via software interface	enabled via stand-aloneworkplace software installation
post-processingmethods(syngo CTVA30 enable asubset ofmethods on thescanner softwareinstallation –only applicablefor previouslyclearedsyngo.CTapplications)	Recon&GO - Inline Resultsvaries methods contained in theavailable applicationssyngo.CT Coronary Analysissyngo.CT Vascular Analysissyngo.CT Dual Energysyngo.CT Bone Readingsyngo.via RT Image SuiteNote 1: Detailed informationabout the subset of enabledsyngo.CT functionalities is listedbelow.	Recon&GO - Inline Resultsvaries methods contained in theavailable applicationssyngo.CT Vascular Analysis,syngo.CT Bone Reading,syngo.CT MM Oncology,syngo.CT Dual Energysyngo.via (incl. MM Reading,ALPHA technology)syngo.CT Clinical Extensionssyngo.CT LungCADsyngo.via RT Image Suite	varies methods contained in theavailable applicationsThe user will operate the SOM/7-based scannerworkplace and in addition havethe possibility to use post-processing applications providedby a syngo.via-based system onthe acquisition workplace.

Cybersecurity	IT Hardening	IT Hardening	IT Hardening
HD FoV	HD FoV 4.0	HD FoV 3.0	HD FoV 4.0
Standardtechnologies	● FAST Features● CARE Features● GO technology	● FAST Features● CARE FeaturesGO technology●	● FAST Features● CARE Features● GO technology
	DirectDensityTM	N/A	DirectDensityTM
DirectDensityTM	(including relative electrondensity and relative mass density)		(including relative electrondensity and relative mass density)

Table S04: SOMATOM go.Platform comparable software properties
---------------------------------------------------------------

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	Subject Device	Primary Predicate Device	Predicate Device
Propertiessoftware	SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro(syngo CT VA30)	SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top	SOMATOM Edge Plus
breath-holdtechnique	Respiratory Motion Managementsupport breath hold triggeredspiral scans with manual breathhold triggered examinations.	Respiratory Motion Managementsupport breath hold triggeredspiral scans with manual breathhold triggered examinations.	Respiratory Motion Managementsupport breath hold triggeredspiral scans with manual breathhold triggered examinations andDirectBreathholdTM (automatedtrigger supported)
Respiratorygating scanmodes	Respiratory gated spiral andrespiratory triggered sequencescan modes	Respiratory gated spiral scanmode	Respiratory gated spiral scanmode,automatically triggeredprospective spiral scan mode
IterativeReconstructionMethods	SAFIRE iMAR	SAFIRE iMAR	ADMIRE SAFIRE iMAR

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 devicesoftware application that supportsame reconstruction tools
Recon&GO / Spectral Recon support image types	Reference Device K191468 -
- Virtual Unenhanced	syngo.CT Dual Energy
- Monoenergetic Plus
Recon&GO / Inline Results DE SPP support	Reference Device K191468 -
- Dual Energy Spectral Post-Processing	syngo.CT Dual Energy
Recon&GO – Inline Results DE Ranges support the applicationclasses:	Reference Device K191468 -
	syngo.CT Dual Energy
- Bone Removal/Direct Angio
- Liver VNC
- Monoenergetic +
- Virtual Unenhanced
- Lung Analysis
- Gout
- Kidney Stones*)
- Bone Marrow
- Brain Hemorrhage
- Rho/Z
- Liver Fat Map
*) Kidney Stones is designed to support the visualization of the
chemical composition of kidney stones and especially the
differentiation between uric acid and non-uric acid stones. For
full identification of the kidney stone additional clinical
information should be considered such as patient history and

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Recon&GO - Advanced Reconstruction	510(k) information of the medical devicesoftware application that supportsome reconstruction tools
urine testing. Only a well-trained radiologist can make the finaldiagnosis under consideration of all available information. Theaccuracy of identification is decreased in obese patients.

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

Enabled Recon&GO – Post-Processing plug infunctions	510(k) information of the medical device softwareapplication that support same established post-processing methods
Heart Isolation, Coronary Tree,Vessel Ranges (LAD, RCA, CX), Cardiac Ranges	Reference Device K173637 - syngo.CT CoronaryAnalysis
Vascular ranges (Aorta, Carotis L Int., Carotic R Int.,Runoff L, Runoff R)Inline Table removal, Inline Bone removal	Reference Device K173637 – syngo.CT VascularAnalysis
Lung CAD - Supported by SOMATOM go.Now,go.Up, go.All and go.Top	Reference Device K143196 - syngo.CT LungCAD
Anatomical ranges (Parallel/Radial) – Supported bySOMATOM go.Now, go.Up, go.All and go.Top	Reference Device K150843 - syngo.via softwareversion VB10 support (Organ Ranges)
Radial Rib Ranges, Parallel Rib Ranges and SpineRange	Reference Device K123584 - syngo.CT BoneReading
3D and 4D image visualization, manipulation andmanual contouring tools for preparation and responseassessment of radiotherapy treatment	Reference Device K192065 - syngo.via RT ImageSuite

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

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 devices, the SOMATOM CT Scanner Systems, are comparable to the predicate devices in terms of technological characteristics 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 go. Platform CT Scanner Systems 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 ●

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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 considered for this process, including creation of test specifications that relate to software/hardware requirements including tests to address risk mitigations that are identified, documented and traced by hazard keys.

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

#	Feature/Non-ClinicalSupportive Testing	Document Title	Testing Performed
01	kV and Filter independentCaScore	Evaluation ofDirectDensity andArtificial120 kernelson Somaris/10 VA30	The test results show that performance of special kernelvariants Artifical120 and eDDensity and mDDensity issimilar or improved within the limits of accuracy of thetest compared to the respective initial release versions.In conclusion, the features DirectDensity and CalciumScoring at any kV have been enabled for the releaseSOMARIS/10 VA30.
02	Recon&GO - SpectralRecon	Detailed Descriptionand Bench Test forthe Feature "SpectralRecon"	Deviations between the already cleared imageprocessing algorithms in Inline DE and the newtechnical realization "Spectral Recon" are extremelysmall and are not expected to have any impact on thediagnostic performance. Residual deviations are aconsequence of rounding differences and slightdifferences in implementation.
03	TwinSpiral Dual Energy /TwinSpiral DE	Detailed Descriptionand Bench Testfor the Feature"TwinSpiral"	Based on these results it can be stated that theTwinSpiral Dual Energy CT scan mode provides CT-images of diagnostic quality, which are similar toconventional 120kV images in terms of CT-values andimage noise at same radiation dose. The mixed imagesshow a slight reduction in the iodine CT-value, but atthe same time image noise at same dose is also lower.So in combination the iodine CNR at same radiationdose is comparable between Mixed images and 120kVimages.
04	Flex 4D Spiral -Neuro/Body	Flex4D Spiral:Technical principalsand demonstration offreely selectable scanranges (Somaris/10VA30)	Scan ranges with the new Flex4D Spiral feature can befreely selected within the limits mandated by the scanmode and protocol. The scanned volume was found tobe in agreement with the planned scan range for avariety of different tested scan modes, scan lengths andscanners.Radiochromic film placed in the isocenter for a varietyof scan ranges showed that the irradiated range markersdisplayed by the scanner acquisition software duringthe planning of the respective F4DS scans were in goodagreement with the exposed area on the film.
05	DirectDensity	Evaluation ofDirectDensity andArtificial120 kernelson Somaris/10 VA30	Evaluation of phantom images to demonstrate thesubject device features ability to provide images thatcan be shown as relative mass density or relativeelectron density. The conducted test performeddemonstrated the subject device's ability to showrelative mass or relative electron density images.
06	HD FoV	HDFoV 4.0:Technical principlesand phantom	Phantom testing conducted to assess the subject deviceability to provide visualization of anatomies outside the
#	Feature/Non-ClinicalSupportive Testing	Document Title	Testing Performed
		measurementsevaluating HUaccuracy and skin-line accuracy in theextended field ofview (FoV) region(Som/10 VA30)	standard field of view and that the image qualitystandards for radiotherapy applications are met.
07	Contrast media protocol	Siemens Healthineersfactory contrastprotocols andcomparison toapproved druglabeling	All Factory Contrast Protocols are within the limits asprescribed by the approved labeling of Ultravist®".(no protocol for coronary CTA)
08	InjectorCoupling	Siemens HealthineersInjection ParameterExchange Validation	Correctness of the contrast injection parameterstransferred between the CT device and the supportedinjection devices has been verified.
09	Direct i4D	Assessment of Directi4D	The test results show that with Direct i4D it is possibleto acquire data for a full breathing cycle at everyposition of the patient even if the respiratory ratechanges during the data acquisition. Compared to theconventional 4DCT scan mode interpolation artifacts(which occur because not for every position a completebreathing cycle could be acquired) can successfully beavoided with Direct i4D.
10	Check&GO	Detailed Descriptionand Bench Test forthe Feature"Check&GO"	500 CT-series from 100 patients were used for thetesting of the algorithm. The datasets were manuallyannotated with a detailed GT contrast-state (None,Low, InhomogeneousLow, Standard,InhomogeneousHigh, High). Check&GO feature can beproven helpful in aiding the user to reduce instanceswhere the image quality may be compromised.
11	Siemens Direct Laser (RTPLaser)	Unit Test Report	RTP-Laser Electronics - Test specification (Unit)Version 00 and Report- General Requirements- Mechanics, Connectors- Function requirementsAttachment 12 to Report CN19-003-AU01-S01-TR31- Test for the new RTP Laser Unit 10830876- Integral Light Markers For Patient Marking (IEC60601-2-44)

Table S07: Non-Clinical Performance Testing

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Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM CT Scanner Systems in accordance with the following standards: 60601-2-44, and 60601-1-2. A list of recognized and general consensus standards considered for the subject devices is provided as Table S08 and Table S09 below.

Table S08: Recognized Consensus Standards
Date ofRecognition	RecognitionNumber	StandardDevelopingOrganization	Standard DesignationNumber and Date	Title of Standard
06/27/2016	12-300	NEMA	PS 3.1 - 3.20 (2016)	Digital Imaging AndCommunications In Medicine(DICOM) Set
03/14/2011	12-225	NEMA	XR-25	Computed Tomography Dose Check
01/27/2015	12-287	NEMA	XR-28 2013	Supplemental Requirements For UserInformation And System FunctionRelated To Dose In CT
Table S08: Recognized Consensus Standards
Date ofRecognition	RecognitionNumber	StandardDevelopingOrganization	Standard DesignationNumber and Date	Title of Standard
6/27/2016	5-40	ANSI AAMIISO	14971:2007/(R)2010(Corrected 4 October2007)	Medical Devices - Applications OfRisk Management To MedicalDevices
		ISO	14971 Second Edition2007-03-01	Medical Devices - Applications OfRisk Management To MedicalDevices
01/14/2019	13-79	IEC	62304 Edition 1.1 2015-06 CONSOLIDATEDVERSION	Medical Device Software - SoftwareLife Cycle Processes
07/09/2014	19-4	ANSI AAMI	ES60601-1:2005/(R)2012And A1:2012,	C1:2009/(R)2012 AndA2:2010/(R)2012 (ConsolidatedText) Medical Electrical Equipment -Part 1: General Requirements ForBasic Safety And EssentialPerformance (IEC 60601-1:2005,MOD)
09/17/2018	19-8	ANSI AAMIIEC	60601-1-2:2014	Medical Electrical Equipment -- Part1-2: General Requirements For BasicSafety And Essential Performance --Collateral Standard: ElectromagneticDisturbances -- Requirements AndTests
7212/23/2016	5-114	ANSI AAMIIEC	62366-1:2015	Medical Devices - Part 1: ApplicationOf Usability Engineering To MedicalDevices
07/09/2014	12-273	IEC	60825-1 Edition 2.02007-03	Safety Of Laser Products - Part 1:Equipment Classification, AndRequirements [Including: TechnicalCorrigendum 1 (2008), InterpretationSheet 1 (2007), Interpretation Sheet 2(2007)]
06/27/2016	12-302	IEC	60601-2-44 Edition 3.2:2016	Medical Electrical Equipment - Part2-44: Particular Requirements ForThe Basic Safety And EssentialPerformance Of X-Ray EquipmentFor Computed Tomography
01/14/2014	12-269	IEC	60601-1-3 Edition 2.12013-04	Medical Electrical Equipment - Part1-3: General Requirements For BasicSafety And Essential Performance -Collateral Standard: RadiationProtection In Diagnostic X-RayEquipment
06/27/2016	5-89	IEC	60601-1-6 Edition 3.12013-10	Medical Electrical Equipment - Part1-6: General Requirements For BasicSafety And Essential Performance -Collateral Standard: Usability
03/14/2011	12-226	IEC	61223-2-6 SecondEdition 2006-11	Evaluation And Routine Testing InMedical Imaging Departments - Part2-6: Constancy Tests - ImagingPerformance Of ComputedTomography X-Ray Equipment
01/30/2014	12-270	IEC	61223-3-5 First Edition2004-08	Evaluation And Routine Testing InMedical Imaging Departments - Part3-5: Acceptance Tests - ImagingPerformance Of ComputedTomography X-Ray Equipment[Including: Technical Corrigendum 1(2006)]
06/07/2018	12-309	IEC	60601-2-28 Edition 3.02017-06	Medical Electrical Equipment - Part2-28: Particular Requirements ForThe Basic Safety And Essential
Table S08: Recognized Consensus Standards
Date ofRecognition	RecognitionNumber	StandardDevelopingOrganization	Standard DesignationNumber and Date	Title of Standard
				Performance Of X-Ray TubeAssemblies For Medical Diagnosis
06/27/2016	12-299	IEC	62563-1 Edition 1.1	Medical Electrical Equipment -Medical Image Display Systems -Part 1: Evaluation Methods

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Table S09: General Use Consensus Standards
StandardDevelopingOrganization	StandardDesignationNumber and Date	Title of Standard	How was Standard Used
IEC	60601-1:2005+A1:2012	Medical electrical equipment -part 1: general requirements forbasic safety and essentialperformance	Covered by ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 as part of EMCtesting.
IEC/ISO	17050-1	Conformity Assessment -Supplier's declaration ofconformity - Part 1: Generalrequirements	Declaration of conformance to FDA recognizedconsensus standards.
IEC/ISO	17050-2	Conformity assessment -Supplier's declaration ofconformity - Part 2: Supportingdocumentation.	General consensus standards not currentlyrecognized by FDA.

A list of applicable guidance documents considered for this submission is provided as Table S10 below.

Table S10FDA Guidance Document and Effective Date
1.	Guidance for Industry and FDA Staff - User Fees and Refunds for Premarket Notification Submissions 510(k)Document issued on October 2, 2017
2.	Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)sDocument issued on February 21, 2019
3.	Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s - Guidance for Industryand FDA StaffDocument issued on August 12, 2005
4.	Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a change to an existing device.Document issued on October 25, 2017
5.	Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating SubstantialEquivalence in Premarket Notifications [510(k)]Document Issued on July 28, 2014
6.	Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submission for Software in MedicalDevicesDocument issued on May 11, 2005
7.	Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in Medical DevicesDocument issued on September 9, 1999
8.	Guidance for Industry and FDA Staff: Applying Human Factors and UsabilityEngineering to Medical Devices.Document issued February 3, 2016
9.	Guidance for Industry and FDA Staff: Pediatric Information for X-ray ImagingDevice Premarket Notifications.Document issued on November 28, 2017
10.	Guidance for Industry and FDA Staff: Content of Premarket Submissions forManagement of Cybersecurity in Medical devices.Document issued on October 2, 2014
11.	Guidance for Industry and FDA Staff: Information to Support a Claim ofElectromagnetic Compatibility (EMC) of Electrically-Powered Medical DevicesDocument issued on July 11, 2016
12.	Guidance for Industry and Food Drug Administration Staff: Design considerations and Pre-Market Submissionrecommendations for Interoperable Medical devices

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Table S10	FDA Guidance Document and Effective Date
	Document Issued on September 6, 2017
13.	Guidance for Industry and Food Drug Administration Staff:Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical DevicesDocument issued on September 14, 2018

Verification and Validation

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.

Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission.

Additionally, Siemens conforms to the requirements for Radio Frequency Wireless Technology as defined in FDA guidance document "Radio Frequency Wireless Technology in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued on August 14, 2013" by adhering to the EMC and risk based verification and validation requirements in design, testing, and labeling of the wireless remote control components of the subject devices.

The Radio Frequency Wireless Technology of the optional Remote Scan Control and supporting Control Device tablet for Scan&GO complies to 47 CFR part 15 subpart c – Intentional Radiators. All Radio device labels will show an FCC ID code to show compliance. Shielding requirement applicable to the CT Scanners and respective Scatter Radiation diagrams for typical room installations are provided in the User Documentation and Planning Guide of the intended Scanners in accordance to IEC60601-2-44.

Wireless Coexistence Testing

Siemens has considered several measures to address wireless coexistence by design to ensure the safe operation of the wireless components in combination with the applicable system supported functionality. Wireless technology in the system setup to perform a task in a given shared environment where other systems have an ability to perform their tasks and may or may not be using the same set of rules has been considered. According to FDA guidance 'Radio Frequency Wireless Technology in Medical Devices' Siemens has addressed the safety, effectiveness, and high likelihood of coexistence with other devices of this technology in our product design by our Risk Management Process, Failure Mode and Effects Analysis (FMEA) Process, and Requirement Engineering Process. As part of the risk management process, hazardous situations associated with the Scan&GO and its connection to the host system via Wi-Fi were addressed as part of the Risk Management process.

Testing for co-existence considered for following scenarios:

Co-Channel Testing ●
Adjacent Channel Testing
RF Interference Testing
. Separation Distance/Location Testing

Scan&GO is designed to allow dynamic frequency selection and transmission power control by default in accordance with IEEE 802.11h. Adjacent channel testing is addressed by the fact that Scan&GO does not support shared medium access to Siemens Wi-Fi network. RF interference was tested by successfully ensuring that wireless communications were actively transmitting in situations where possible interference may exist. Recommended distance and router locations requirements are documented in the user documentation.

Customer Use Testing

The following clinical use testing was conducted to demonstrate Scan&GO's performance in the intended clinical environment:

Internal Clinical Use Test: The CT scanner customer environment is simulated in Siemens Test Cabins. For such a test, customers with clinical expertise are typically invited to perform tests.

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. External Clinical Use Test: The CT scanner is tested in the environment of the clinic/hospital. Typically we perform these tests with selected customer before rollout of the CT scanner.
All tests performed meet the pre-determined acceptance criteria and demonstrate that Scan&GO is safe and effective for the intended use. Multiple tablets for visualization purpose, using the same Scan&GO installation and feature configuration, does not change the intended use.

Additional Supportive Data

The National Lung Screening Trial (NLST), sponsored by the National Cancer Institute, is used to support the additional lung cancer screening Indications for Use. The study was a randomized trial of screening with the use of low-dose CT compared to chest radiography to determine with low-dose CT could reduce mortality from lung cancer. The study start date was August 2002 and the completion date was October, 2010. The interpretation task with CT for this study was to detect lung nodules of 4mm diameter or greater.

Summary

The features described in this premarket notification are supported with verification and validation testing, dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance during product development. The risk analysis was completed, and risk control implemented to mitigate identified hazards. The test results show that all of the software specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence.

General Safety and Effectiveness Concerns

The device labeling contains instructions for use as well as necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a system related Risk analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing according to the Risk Management process. In order to minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

VIII. Conclusions

The predicate devices were cleared based on the results of non-clinical testing including verification and validation, phantom tests, and supportive literature. The subject devices are also tested using the same test methods and workflows as used for the predicate devices. The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the SOMATOM go. Platform should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM go. Platform with described modifications performs comparably to the predicate devices currently marketed for the same intended use. Since the subject and predicate devices were tested using the same methods, Siemens believes that the data generated from the SOMATOM testing supports a finding of substantial equivalence.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.