Predicate Devices

Reference Devices

K191468, K173637, K143196, K150843, K123584, K192065

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The summary mentions "Check&GO algorithm" and describes testing involving manual annotation of datasets with detailed contrast-state ground truth, which is characteristic of training or evaluating an algorithm, potentially an ML algorithm, for image quality assessment or optimization.

Therapeutic

No.
The device is described as a diagnostic imaging system (CT scanner) used to generate images for aid in diagnosis, treatment preparation, and radiation therapy planning, not to provide therapy itself.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that "The images delivered by the system can be used by a trained physician as an aid in diagnosis." This directly indicates its role as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device is described as a "Computed Tomography Xray System" which features a "continuously rotating tube-detector system". This clearly indicates the presence of hardware components beyond just software. While it includes software components like Scan&GO, the core device is a physical CT scanner.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
Device Function: This device is a Computed Tomography (CT) system. It generates images of the inside of the patient's body using X-rays. It does not examine specimens in vitro.
Intended Use: The intended use is to generate and process images of patients to aid in diagnosis, treatment preparation, and radiation therapy planning. This is done by imaging the patient directly, not by analyzing samples outside the body.

While the images produced by the CT system are used to aid in diagnosis, the device itself is an imaging system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The term "Control Plan Authorized (PCCP)" is present as a section heading by the user, but the content "Not Found" under it further confirms the absence of any information regarding PCCP authorization in the provided text.

Overview

Intended Use / Indications for Use

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

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 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.

Product codes (comma separated list FDA assigned to the subject device)

JAK, LLZ

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)

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. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet that meets certain minimum requirements:

Selection of patients O
Selection of pre-defined protocols O
Scan parameter display O
Patient table position display and gantry tilt parameter display O
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:

New/Modified Hardware

Table S01: Overview of Hardware modifications ●

Software version SOMARIS/10 syngo CT VA30

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography x-ray

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physician, trained staff / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

500 CT-series from 100 patients were used for the testing of the algorithm. The datasets were manually annotated with a detailed GT contrast-state (None, Low, InhomogeneousLow, Standard, InhomogeneousHigh, High).

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 ●

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.

Table S07: Non-Clinical Performance Testing
Feature/Non-Clinical Supportive Testing: kV and Filter independent CaScore
Document Title: Evaluation of DirectDensity and Artificial120 kernels on Somaris/10 VA30
Testing Performed: 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.

Feature/Non-Clinical Supportive Testing: Recon&GO - Spectral Recon
Document Title: Detailed Description and Bench Test for the Feature "Spectral Recon"
Testing Performed: 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.

Feature/Non-Clinical Supportive Testing: TwinSpiral Dual Energy / TwinSpiral DE
Document Title: Detailed Description and Bench Test for the Feature "TwinSpiral"
Testing Performed: 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.

Feature/Non-Clinical Supportive Testing: Flex 4D Spiral - Neuro/Body
Document Title: Flex4D Spiral: Technical principals and demonstration of freely selectable scan ranges (Somaris/10 VA30)
Testing Performed: 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.

Feature/Non-Clinical Supportive Testing: DirectDensity
Document Title: Evaluation of DirectDensity and Artificial120 kernels on Somaris/10 VA30
Testing Performed: Evaluation of phantom images to demonstrate the subject device features ability to provide images that can be shown as relative mass density or relative electron density. The conducted test performed demonstrated the subject device's ability to show relative mass or relative electron density images.

Feature/Non-Clinical Supportive Testing: HD FoV
Document Title: HDFoV 4.0: Technical principles and phantom measurements evaluating HU accuracy and skin-line accuracy in the extended field of view (FoV) region (Som/10 VA30)
Testing Performed: 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.

Feature/Non-Clinical Supportive Testing: Contrast media protocol
Document Title: Siemens Healthineers factory contrast protocols and comparison to approved drug labeling
Testing Performed: All Factory Contrast Protocols are within the limits as prescribed by the approved labeling of Ultravist®". (no protocol for coronary CTA)

Feature/Non-Clinical Supportive Testing: InjectorCoupling
Document Title: Siemens Healthineers Injection Parameter Exchange Validation
Testing Performed: Correctness of the contrast injection parameters transferred between the CT device and the supported injection devices has been verified.

Feature/Non-Clinical Supportive Testing: Direct i4D
Document Title: Assessment of Direct i4D
Testing Performed: 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.

Feature/Non-Clinical Supportive Testing: Check&GO
Document Title: Detailed Description and Bench Test for the Feature "Check&GO"
Testing Performed: 500 CT-series from 100 patients were used for the testing of the algorithm. The datasets were manually annotated with a detailed GT contrast-state (None, Low, InhomogeneousLow, Standard, InhomogeneousHigh, High). Check&GO feature can be proven helpful in aiding the user to reduce instances where the image quality may be compromised.

Feature/Non-Clinical Supportive Testing: Siemens Direct Laser (RTP Laser)
Document Title: Unit Test Report
Testing Performed: 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)

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.
. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K173632, K190578

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K191468, K173637, K143196, K150843, K123584, K192065

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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.

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

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

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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

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

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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.

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

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

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."

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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, SOMATOM
Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus,
SOMATOM Definition AS/AS+, SOMATOM Confidence
510(k) Number:	K190578
Clearance Date:	June 27, 2019
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	There are currently no recalls for this device

Note: K190578 was a bundle submission with various Siemens SOMATOM CT Scanner Systems. In this Submission, the predicate devices SOMATOM Force and SOMATOM Edge Plus are applicable, to demonstrate substantial equivalence of technological characteristics.

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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)

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. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet that meets certain minimum requirements:

Selection of patients O
Selection of pre-defined protocols O
Scan parameter display O
Patient table position display and gantry tilt parameter display O
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:

7

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 Devices
SOMATOM go.Now | Subject Devices
SOMATOM go.Up | Subject Devices
SOMATOM go.All | Subject Devices
SOMATOM go.Top | Subject Devices
SOMATOM go.Sim | Subject Devices
SOMATOM go.Open Pro |
|---|-----------------------------------------------------------------------------|-----------------------------------|----------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|----------------------------------------|
| 1 | Patient
Observation
Camera | Unmodified | Unmodified | Unmodified | Unmodified | Modified | Modified |
| 2 | Moodlight | Unmodified | Unmodified | Unmodified | Unmodified | Modified | Modified |
| 3 | Various Tablet
Configuration | Modified | Modified | Modified | Modified | Modified | Modified |
| 4 | High Power 70 /
High Power 80 | Unmodified | Unmodified | Unmodified | Unmodified | Enabled | Enabled |
| 5 | Adaptive Dose
Shield | 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 Patient
Marking –
Direct Laser | N/A | N/A | N/A | N/A | New | New |
| 9 | Other hardware
modifications
(e.g. new large
bore size and
FoV) | 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 CT
System Scanner
with
SOMARIS/10
syngo CT VA30 | Subject
Devices | Subject
Devices | Subject
Devices | Subject
Devices | Subject
Devices | Subject
Devices | Subject
Devices |
|---|---------------------------------------------------------------------|--------------------|--------------------|--------------------|--------------------|--------------------|------------------------|--------------------|
| | Software
properties | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.All | SOMATOM
go.Top | SOMATOM
go.Sim | SOMATOM
go.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 |

8

| | SOMATOM CT
System Scanner
with
SOMARIS/10
syngo CT VA30 | Subject
Devices | Subject
Devices | Subject
Devices | Subject
Devices | Subject
Devices | Subject
Devices | Subject
Devices |
|----|---------------------------------------------------------------------|--------------------|--------------------|--------------------|--------------------|--------------------|------------------------|--------------------|
| | Software
properties | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.All | SOMATOM
go.Top | SOMATOM
go.Sim | SOMATOM
go.Open Pro | Scan&GO |
| 7 | Check&GO - Metal
Detection | New | New | New | New | New | New | New |
| 8 | CARE Contrast III
and Contrast media
protocol | Modified | Modified | Modified | Modified | Modified | Modified | N/A |
| 9 | CARE kV | N/A | N/A | Modified | Modified | Modified | Modified | N/A |
| 10 | kV and Filter
independent
CaScore
(Artificial120) | N/A | Enabled | Enabled | Enabled | Enabled | Enabled | N/A |
| 11 | Recon&GO -
Advanced
Reconstruction | Modified | Modified | Modified | Modified | Modified | Modified | N/A |
| 12 | Recon&GO - Post-
Processing plug in
functions | Modified | Modified | Modified | Modified | Modified | Modified | N/A |
| 13 | TwinBeam Dual
Energy | N/A | N/A | N/A | Modified | N/A | Modified | N/A |
| 14 | TwinSpiral Dual
Energy / TwinSpiral
DE | 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 - Exam
workflow | New | New | New | New | New | New | New |
| 18 | Imaging - Cardio
BestPhase | 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 Motion
Management | Enabled | Enabled | Enabled | Enabled | Enabled | Enabled | N/A |
| 22 | Patient Marking -
Direct Laser
Steering | 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.

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.

9

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

VI. Comparison of Technological Characteristics with the Predicate Device

The SOMATOM 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)

10

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).

11

| | Table S03: SOMATOM go.Platform comparable hardware properties
SOMATOM go.Platform - Device Comparison (Single Source Systems) | | | | | | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-------------------------|-------------------------------------------|------------------------------------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------|
| Hardware
Property | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.All | SOMATOM
go.Top | SOMATOM
go.Sim | SOMATOM
go.Open Pro | Primary
Prediacte
Device
SOMATOM
go.Top
(K173632) |
| Scanner | whole body X-ray computed tomography scanner | | | | | | |
| Generator
max. power | 32 kW | 32 kW | 75 kW | 75 kW | 75 kW | 75 kW | 75 kW |
| Detector
technology | Stellar | Stellar | Stellar | Stellar | Stellar | Stellar | Stellar |
| Detector
volumen
coverage | 11.2 mm | 22.4 mm | 22.4 mm | 38.4 mm | 19.2 mm | 38.4 mm | 38.4 mm |
| Detector
physical rows | 16 | 32 | 32 | 64 | 32 | 64 | 64 |
| Detector
slice width | 0.7 mm | 0.7 mm | 0.7 mm | 0.6 mm | 0.6 mm | 0.6 mm | 0.6 mm |
| Detector
DAS channel
No. | 768 | 768 | 768 | 840 | 920 | 920 | 840 |
| Detector
image slices | 32 | 64 | 64 | 128 | 64 | 128 | 128 |
| Tube
Technologie | Chronon | Chronon | Athlon | Athlon | Athlon | Athlon | Athlon |
| Tube
kV steps | | (in 20kV steps)
80 kV to 130kV | | | (in 10kV steps)
70 kV to 140 kV | | |
| Tube
max. current | 400 mA | 400 mA | 825 mA | 825 mA | 825 mA | 825 mA | 825 mA |
| Tube
tube focus | 0.8 x 0.4
0.8 x 0.7 | 0.8 x 0.4
0.8 x 0.7 | 1.0 x 1.2
0.8 x 0.8 | 1.0 x 1.2
0.8 x 0.8 | 1.0 x 1.2
0.8 x 0.8 | 1.0 x 1.2
0.8 x 0.8 | 1.0 x 1.2
0.8 x 0.8 |
| Tube
heat capacity | 3.5 MHU | 3.5 MHU | 6 MHU | 6 MHU | 6 MHU | 6 MHU | 6 MHU |
| Gantry
bore size | 70 cm | 70 cm | 70 cm | 70 cm | 85 cm | 85 cm | 70 cm |
| Gantry
FoV | 50 cm | 50 cm | 50 cm | 50 cm | 60 cm | 60 cm | 50 cm |
| Gantry
rotation 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 |
| Gantry
Tilt [degrees] | N/A | +/-25 | +/-25 | +/-25 | +/-25 | +/-25 | +/-25 |
| Patient Table
type | Vector:
1.250 m
Vario 1 and
Vario RT:
1.600 m with
table
extension | Vario 1 (1.600 m, Vario 2 (2.000m and Vario
RT: 1.600 m with table extension | | | Vario 2 (2.000m and Vario
RT: 1.600 m with table
extension | | Vario 1
(1.600 m,
Vario 2
(2.000m and
Vario RT:
1.600 m with
table
extension |
| Max. Scan
length
Topogram | 1680 mm | 1680 mm
2080 mm | 1680 mm
2080 mm | 1680 mm
2080 mm | 1680 mm
2080 mm | 1680 mm
2080 mm | 1680 mm
2080 mm |
| Max. Scan
length
Image
acquisition | 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 |
| Spectral
filtration
option | Tin Filter
supported | Tin Filter
supported | Tin Filter
supported | Combined
Split
Filter/Tin
Filter | Tin Filter
supported | Combined
Split
Filter/Tin
Filter | Combined
Split
Filter/Tin
Filter |
| 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).

12

	Subject Device	Primary Predicate Device	Predicate Device
	SOMATOM go.Now,
●	SOMATOM go.Now,
●	SOMATOM Edge Plus
	SOMATOM go.Up,
●	SOMATOM go.Up,
●
Properties
software	SOMATOM go.All,
●	SOMATOM go.All,
●
	SOMATOM go.Top,
●	SOMATOM go.Top ●
	SOMATOM go.Sim,
●
	SOMATOM go.Open Pro
(syngo CT VA30)
		(K173632)	(K190578)
Operating
System	Windows based
SOMARIS/10 syngo CT VA30	Windows based
SOMARIS/10 syngo CT VA20A	Windows based
SOMARIS/7 syngo CT VB20
	syngo Acquisition Workplace
(AWP)	syngo Acquisition Workplace
(AWP)	syngo Acquisition Workplace
(AWP)
Acquisition
Workplace	syngo Viewing, syngo Filming
and syngo Archiving &
Networking	syngo Viewing, syngo Filming
and syngo Archiving &
Networking	syngo Viewing, syngo Filming
and syngo Archiving &
Networking
	Image Reconstruction	Image Reconstruction	Image Reconstruction
Stellar Detector	Stellar detector firmware
supported	Stellar detector firmware
supported	Stellar detector firmware
supported
Teamplay	Support teamplay Protocols	Support teamplay Protocols	Support teamplay Protocols
	Support of:
● Protocols for Radiation
Therapy Planning support
patient marking
● Protocols that allow scanning
with support of an external
respiratory gating system
(ANZAI, Varian RGSC)
● Protocol supporting contrast
bolus-triggered data
acquisition
● Contrast media protocols
● Pediatric Protocols
● Flex Dose Profile
● TwinBeam DE
● TwinSpiral DE
● Flex 4D Spiral	Support of:
● Protocols for Radiation
Therapy Planning
● Protocol supporting contrast
bolus-triggered data
acquisition
● Pediatric Protocols	Support of :
● Protocols for Radiation
Therapy Planning
● Protocols for Radiation
Therapy Planning
● Protocols that allow
triggering of breath hold
scanning from external
device.
● Protocol supporting contrast
bolus-triggered data
acquisition
● Pediatric Protocols
● Adaptive Dose Area
● DualSource DE
● Adaptive 4D Spiral
Protocols


	enabled via software interface	enabled via software interface	enabled via stand-alone
workplace software installation
post-processing
methods
(syngo CT
VA30 enable a
subset of
methods on the
scanner software
installation –
only applicable
for previously
cleared
syngo.CT
applications)	Recon&GO - Inline Results
varies methods contained in the
available applications
syngo.CT Coronary Analysis
syngo.CT Vascular Analysis
syngo.CT Dual Energy
syngo.CT Bone Reading
syngo.via RT Image Suite
Note 1: Detailed information
about the subset of enabled
syngo.CT functionalities is listed
below.	Recon&GO - Inline Results
varies methods contained in the
available applications
syngo.CT Vascular Analysis,
syngo.CT Bone Reading,
syngo.CT MM Oncology,
syngo.CT Dual Energy
syngo.via (incl. MM Reading,
ALPHA technology)
syngo.CT Clinical Extensions
syngo.CT LungCAD
syngo.via RT Image Suite	varies methods contained in the
available applications
The user will operate the SOM/7-
based scanner
workplace and in addition have
the possibility to use post-
processing applications provided
by a syngo.via-based system on
the acquisition workplace.

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

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

13

	Subject Device	Primary Predicate Device	Predicate Device
Properties
software	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-hold
technique	Respiratory Motion Management
support breath hold triggered
spiral scans with manual breath
hold triggered examinations.	Respiratory Motion Management
support breath hold triggered
spiral scans with manual breath
hold triggered examinations.	Respiratory Motion Management
support breath hold triggered
spiral scans with manual breath
hold triggered examinations and
DirectBreathholdTM (automated
trigger supported)
Respiratory
gating scan
modes	Respiratory gated spiral and
respiratory triggered sequence
scan modes	Respiratory gated spiral scan
mode	Respiratory gated spiral scan
mode,
automatically triggered
prospective spiral scan mode
Iterative
Reconstruction
Methods	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 device
software application that support
same 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 application
classes: | 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 | |

14

| Recon&GO - Advanced Reconstruction | 510(k) information of the medical device
software application that support
some reconstruction tools |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| urine testing. Only a well-trained radiologist can make the final
diagnosis under consideration of all available information. The
accuracy 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 in
functions | 510(k) information of the medical device software
application that support same established post-
processing methods |
|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Heart Isolation, Coronary Tree,
Vessel Ranges (LAD, RCA, CX), Cardiac Ranges | Reference Device K173637 - syngo.CT Coronary
Analysis |
| Vascular ranges (Aorta, Carotis L Int., Carotic R Int.,
Runoff L, Runoff R)
Inline Table removal, Inline Bone removal | Reference Device K173637 – syngo.CT Vascular
Analysis |
| 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 by
SOMATOM go.Now, go.Up, go.All and go.Top | Reference Device K150843 - syngo.via software
version VB10 support (Organ Ranges) |
| Radial Rib Ranges, Parallel Rib Ranges and Spine
Range | Reference Device K123584 - syngo.CT Bone
Reading |
| 3D and 4D image visualization, manipulation and
manual contouring tools for preparation and response
assessment of radiotherapy treatment | Reference Device K192065 - syngo.via RT Image
Suite |

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 ●

15

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-Clinical
Supportive Testing | Document Title | Testing Performed |
|----|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 01 | kV and Filter independent
CaScore | Evaluation of
DirectDensity and
Artificial120 kernels
on Somaris/10 VA30 | The test results show that performance of special kernel
variants Artifical120 and eDDensity and mDDensity is
similar or improved within the limits of accuracy of the
test 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. |
| 02 | Recon&GO - Spectral
Recon | Detailed Description
and Bench Test for
the Feature "Spectral
Recon" | Deviations between the already cleared image
processing algorithms in Inline DE and the new
technical realization "Spectral Recon" are extremely
small and are not expected to have any impact on the
diagnostic performance. Residual deviations are a
consequence of rounding differences and slight
differences in implementation. |
| 03 | TwinSpiral Dual Energy /
TwinSpiral DE | Detailed Description
and Bench Test
for the Feature
"TwinSpiral" | Based on these results it can be stated that the
TwinSpiral Dual Energy CT scan mode provides CT-
images of diagnostic quality, which are similar to
conventional 120kV images in terms of CT-values and
image noise at same radiation dose. The mixed images
show a slight reduction in the iodine CT-value, but at
the same time image noise at same dose is also lower.
So in combination the iodine CNR at same radiation
dose is comparable between Mixed images and 120kV
images. |
| 04 | Flex 4D Spiral -
Neuro/Body | Flex4D Spiral:
Technical principals
and demonstration of
freely selectable scan
ranges (Somaris/10
VA30) | Scan ranges with the new Flex4D Spiral feature can be
freely selected within the limits mandated by the scan
mode and protocol. The scanned volume was found to
be in agreement with the planned scan range for a
variety of different tested scan modes, scan lengths and
scanners.
Radiochromic film placed in the isocenter for a variety
of scan ranges showed that the irradiated range markers
displayed by the scanner acquisition software during
the planning of the respective F4DS scans were in good
agreement with the exposed area on the film. |
| 05 | DirectDensity | Evaluation of
DirectDensity and
Artificial120 kernels
on Somaris/10 VA30 | Evaluation of phantom images to demonstrate the
subject device features ability to provide images that
can be shown as relative mass density or relative
electron density. The conducted test performed
demonstrated the subject device's ability to show
relative mass or relative electron density images. |
| 06 | HD FoV | HDFoV 4.0:
Technical principles
and phantom | Phantom testing conducted to assess the subject device
ability to provide visualization of anatomies outside the |
| # | Feature/Non-Clinical
Supportive Testing | Document Title | Testing Performed |
| | | measurements
evaluating HU
accuracy and skin-
line accuracy in the
extended field of
view (FoV) region
(Som/10 VA30) | standard field of view and that the image quality
standards for radiotherapy applications are met. |
| 07 | Contrast media protocol | Siemens Healthineers
factory contrast
protocols and
comparison to
approved drug
labeling | All Factory Contrast Protocols are within the limits as
prescribed by the approved labeling of Ultravist®".
(no protocol for coronary CTA) |
| 08 | InjectorCoupling | Siemens Healthineers
Injection Parameter
Exchange Validation | Correctness of the contrast injection parameters
transferred between the CT device and the supported
injection devices has been verified. |
| 09 | Direct i4D | Assessment of Direct
i4D | 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. |
| 10 | Check&GO | Detailed Description
and Bench Test for
the Feature
"Check&GO" | 500 CT-series from 100 patients were used for the
testing of the algorithm. The datasets were manually
annotated with a detailed GT contrast-state (None,
Low, InhomogeneousLow, Standard,
InhomogeneousHigh, High). Check&GO feature can be
proven helpful in aiding the user to reduce instances
where the image quality may be compromised. |
| 11 | Siemens Direct Laser (RTP
Laser) | Unit Test Report | 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) |

Table S07: Non-Clinical Performance Testing

16

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 of
Recognition	Recognition
Number	Standard
Developing
Organization	Standard Designation
Number and Date	Title of Standard
06/27/2016	12-300	NEMA	PS 3.1 - 3.20 (2016)	Digital Imaging And
Communications 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 User
Information And System Function
Related To Dose In CT
Table S08: Recognized Consensus Standards
Date of
Recognition	Recognition
Number	Standard
Developing
Organization	Standard Designation
Number and Date	Title of Standard
6/27/2016	5-40	ANSI AAMI
ISO	14971:2007/(R)2010
(Corrected 4 October

| Medical Devices - Applications Of
Risk Management To Medical
Devices |
| | | ISO | 14971 Second Edition
2007-03-01 | Medical Devices - Applications Of
Risk Management To Medical
Devices |
| 01/14/2019 | 13-79 | IEC | 62304 Edition 1.1 2015-
06 CONSOLIDATED
VERSION | Medical Device Software - Software
Life Cycle Processes |
| 07/09/2014 | 19-4 | ANSI AAMI | ES60601-1:2005/(R)2012
And A1:2012, | C1:2009/(R)2012 And
A2:2010/(R)2012 (Consolidated
Text) Medical Electrical Equipment -
Part 1: General Requirements For
Basic Safety And Essential
Performance (IEC 60601-1:2005,
MOD) |
| 09/17/2018 | 19-8 | ANSI AAMI
IEC | 60601-1-2:2014 | Medical Electrical Equipment -- Part
1-2: General Requirements For Basic
Safety And Essential Performance --
Collateral Standard: Electromagnetic
Disturbances -- Requirements And
Tests |
| 7212/23/2016 | 5-114 | ANSI AAMI
IEC | 62366-1:2015 | 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 [Including: Technical
Corrigendum 1 (2008), Interpretation
Sheet 1 (2007), Interpretation Sheet 2
(2007)] |
| 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 Essential
Performance Of X-Ray Equipment
For Computed Tomography |
| 01/14/2014 | 12-269 | IEC | 60601-1-3 Edition 2.1
2013-04 | 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 | 5-89 | IEC | 60601-1-6 Edition 3.1
2013-10 | Medical Electrical Equipment - Part
1-6: General Requirements For Basic
Safety And Essential Performance -
Collateral Standard: Usability |
| 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 |
| 01/30/2014 | 12-270 | IEC | 61223-3-5 First Edition
2004-08 | Evaluation And Routine Testing In
Medical Imaging Departments - Part
3-5: Acceptance Tests - Imaging
Performance Of Computed
Tomography X-Ray Equipment
[Including: Technical Corrigendum 1
(2006)] |
| 06/07/2018 | 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 |
| Table S08: Recognized Consensus Standards | | | | |
| Date of
Recognition | Recognition
Number | Standard
Developing
Organization | Standard Designation
Number and Date | Title of Standard |
| | | | | Performance Of X-Ray Tube
Assemblies 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 |

17

18

Table S09: General Use Consensus Standards
Standard
Developing
Organizatio
n	Standard
Designation
Number and Date	Title of Standard	How was Standard Used
IEC	60601-
1:2005+A1:2012	Medical electrical equipment -
part 1: general requirements for
basic safety and essential
performance	Covered by ANSI AAMI ES60601-
1:2005/(R)2012 and A1:2012 as part of EMC
testing.
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.

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

| Table S10

FDA 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)s
Document issued on February 21, 2019
3.	Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s - Guidance for Industry
and FDA Staff
Document 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 Substantial
Equivalence 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 Medical
Devices
Document issued on May 11, 2005
7.	Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in Medical Devices
Document issued on September 9, 1999
8.	Guidance for Industry and FDA Staff: Applying Human Factors and Usability
Engineering to Medical Devices.
Document issued February 3, 2016
9.	Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging
Device Premarket Notifications.
Document issued on November 28, 2017
10.	Guidance for Industry and FDA Staff: Content of Premarket Submissions for
Management of Cybersecurity in Medical devices.
Document issued on October 2, 2014
11.	Guidance for Industry and FDA Staff: Information to Support a Claim of
Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices
Document issued on July 11, 2016
12.	Guidance for Industry and Food Drug Administration Staff: Design considerations and Pre-Market Submission
recommendations for Interoperable Medical devices

19

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 Devices
Document 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.

20

. 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.