SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO by Siemens Medical Solutions USA, Inc.

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. High risk populations are 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.

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 SOMATOM go.Platform is comprised of the following 4 CT scanners and optional mobile workflow:

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

The CT scanners feature one continuously rotating tube-detector system and function according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The above referenced CT scanners produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment preparation. 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 workflow of the SOMATOM go.Platform CT scanners. Scan&GO can be operated on a Siemens provided tablet or a commercially available that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient.

AI/ML Overview

The provided text describes the acceptance criteria and supporting studies for the Siemens SOMATOM go.Platform CT scanners (SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Now, SOMATOM go.Up) and the Scan&GO mobile workflow application.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes general "acceptance criteria" for software specifications and "pre-determined acceptance criteria" for customer use testing, but it does not provide specific quantitative acceptance criteria or reported performance values for clinical metrics. Instead, it emphasizes that testing demonstrated substantial equivalence to predicate devices and conformance to various performance, safety, and regulatory standards.

Therefore, a table with specific acceptance criteria and reported numeric performance cannot be generated from the given text. The text indicates that:

"All test performed meet the pre-determined acceptance criteria."
"The test results show that all of the software specifications have met the acceptance criteria."
"The data included in this submission demonstrates that the SOMATOM go.Platform performs comparably to the predicate devices currently marketed for the same intended use."

This implies that the acceptance criteria were qualitative (e.g., "operates as intended," "comparable to predicate") or met internal Siemens specifications not detailed in this public summary.

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

The document primarily focuses on non-clinical testing.

Test Set Description: Phantom tests, verification and validation testing, software testing, electrical safety and EMC testing, wireless coexistence testing, and customer use testing.
Sample Size: Not explicitly stated for any of the non-clinical tests.
Data Provenance:
- Phantom Tests: Conducted by Siemens during product development.
- Customer Use Tests:
  - Internal Clinical Use Test: Simulated in Siemens Test Cabins with "customers with clinical expertise."
  - External Clinical Use Test: Performed with "selected customer" in a "clinic/hospital environment."
- Additional Supportive Data (Lung Cancer Screening): Refers to the National Lung Screening Trial (NLST) (N Engl J Med 2011; 365:395-409) which was a randomized trial.
  - NLST Sample Size: Not explicitly stated in this document, but the external reference (N Engl J Med 2011; 365:395-409) would contain this information.
  - NLST Data Provenance: Prospective, multi-center trial (implied by "National" and publication in a journal like NEJM). Information regarding country of origin is not explicitly stated in this document but is generally associated with the US for NLST.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Non-clinical Tests: Ground truth for non-clinical tests (e.g., phantom images, software specifications) would typically be established by engineering and quality assurance teams based on design specifications and measurements, rather than clinical experts. No specific number or qualifications of "experts" are provided for these internal assessments.
Customer Use Testing: "Customers with clinical expertise" were invited for internal clinical use tests. "Selected customer" (plural, implying multiple individuals or sites) performed external clinical use tests. No specific number or qualifications (e.g., "radiologist with 10 years experience") are provided.
NLST (for lung cancer screening indication): The NLST identified lung nodules of 4mm diameter or greater. The ground truth for this large-scale clinical trial would involve extensive processes for diagnosis, follow-up, and potentially pathology, but the specific number and qualifications of experts involved in establishing ground truth for the NLST data itself are not detailed in this submission. The submission references the published literature for NLST for further information.

4. Adjudication Method for the Test Set

Non-clinical Tests: Not explicitly stated. For engineering and software testing, adjudication would likely involve issue tracking systems and resolution processes, rather than clinical consensus.
Customer Use Testing: Not explicitly stated. It states that "All test performed meet the pre-determined acceptance criteria," implying that the results were simply assessed against those criteria.
NLST (for lung cancer screening indication): The adjudication methods for the NLST (referencing N Engl J Med 2011; 365:395-409) would be detailed in that study's methodology, but are not described in this 510(k) summary.

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, an MRMC comparative effectiveness study involving AI assistance for human readers was not done.
This submission describes a CT scanner system and its optional mobile workflow application, not an AI-based diagnostic aid that assists human readers. The technologies described are fundamental CT imaging and workflow enhancements.
The NLST is referenced to support the ability of CT systems (not necessarily this specific model or an AI component) to perform low-dose lung cancer screening, but it is not a study comparing human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not specifically done in the context of AI without human-in-the-loop.
The device being cleared is a Computed Tomography (CT) system and an accompanying mobile workflow application. These are imaging devices and tools for workflow, not standalone diagnostic algorithms.
The "software" mentioned (SOMARIS/10 syngo CT VA20) refers to the operating system and processing capabilities of the CT scanner itself, including basic post-processing and interfaces for advanced post-processing, not a standalone diagnostic algorithm for interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Non-clinical (Technical/Performance) Testing: Ground truth for these tests would likely be based on:
- Design specifications: For software functionality and hardware performance (e.g., compliance with IEC standards).
- Measurements against known standards/phantoms: For image quality, radiation dose, electrical safety.
Customer Use Testing: Ground truth would be the intended performance and user experience as validated by clinical users, ensuring the system operates as expected in a clinical context.
Lung Cancer Screening Indication: The justification for the low-dose lung cancer screening indication comes from clinical literature, specifically referencing the National Lung Screening Trial (NLST). For NLST, the ground truth for lung cancer detection would ultimately be pathology and long-term outcomes data (mortality reduction). The submission states NLST's interpretation task was to detect lung nodules ≥ 4mm.

8. The Sample Size for the Training Set

Not applicable. This submission is for a CT scanner platform and a workflow application, not a machine learning or AI algorithm in the context of diagnostic image interpretation that would require a dedicated "training set" for model development. The software mentioned handles system operation, image reconstruction, and basic post-processing, and is not described as involving a machine learning training phase.

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

Not applicable. As no training set for a machine learning algorithm is discussed, the establishment of its ground truth is not relevant here.

Summary

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April 13, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd. MALVERN PA 19355

Re: K173632

Trade/Device Name: SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Now, SOMATOM go.Up. and Scan&Go Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 15, 2018 Received: March 20, 2018

Dear Ms. Mangum:

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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.

510(k) Number (if known)	K173632
Device Name	SOMATOM go.Up
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. High risk populations are 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.

510(k) Number (if known)

K173632

Device Name

SOMATOM go.Up

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. High risk populations are 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word.

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020
Indications for Use	See PRA Statement below.

510(k) Number (if known)
Device Name	SOMATOM go. Top
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. High risk populations are 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)	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.

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

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

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name SOMATOM go.Now

Indications for Use (Describe)

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. High risk populations are 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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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

Image /page/5/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. A black line is located underneath the word.

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
510(k) Number (if known)
Device Name	SOMATOM go.All
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. High risk populations are 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)
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 AdministrationOffice of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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

Image /page/6/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The word is written in a light blue color. There is a black line underneath the word.

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120
Indications for Use	Expiration Date: 06/30/2020See PRA Statement below.

510(k) Number (if known)
Device Name	Scan&GO
Indications for Use (Describe)	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

510(k) Number (if known)

Device Name

Scan&GO

Indications for Use (Describe)

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

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.

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

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

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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Image /page/7/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. The word is displayed horizontally and is the main focus of the image.

510(K) SUMMARY

FOR

SOMATOM GO.PLATFORM SCANNERS

Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: March 15, 2018

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.

l. Submitter

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 Reqistration Number: 3003202425

Contact Person:

Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448-6477 Email: kimberly.mangum@siemens-healthineers.com

II. Device Name and Classification

Product Name:	SOMATOM go.All
Propriety Trade Name:	SOMATOM go.All
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
Primary Product Code:	JAK
Secondary Product Code:	LLZ

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Product Name: Propriety Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Primary Product Code: Secondary Product Code:

Product Name: Propriety Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Product Code: Secondary Product Code:

III. Predicate Device Primary Predicate Device:

Product Name: Propriety Trade Name: 510(k) Number: Clearance Date: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class:

SOMATOM go.Top SOMATOM go.Top Computed Tomography X-Ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21 CFR 892.2050 Class II JAK LLZ SOMATOM go.Now SOMATOM go.Now Computed Tomography X-Ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21 CFR 892.2050 Class II JAK LLZ SOMATOM go.Up SOMATOM go.Up Computed Tomography X-Ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21 CFR 892.2050 Class II JAK LLZ Scan&GO Scan&GO Computed Tomography X-ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21 CFR §892.2050 Class II JAK LLZ SOMATON go.Now, SOMATOM go.Up SOMATON go.Now, SOMATOM go.Up K163296 March 21, 2017 Computed Tomography X-Ray System Picture Archiving and Communications System

Radiology 21 CFR §892.1750 21 CFR 892.2050 Class II

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Primary Product Code: JAK Secondary Product Code: LLZ Recall Information: All applicable recalls are considered and addressed as part of the design control process

Secondary Predicate Devices:

Product Name: Propriety Trade Name: 510(k) Number: Clearance Date: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Product Code: Secondary Product Code: Recall Information:

Scan&GO Scan&GO K163297 March 24, 2017 Computed Tomography X-ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21 CFR §892.2050 Class II JAK LLZ There are currently no design related recalls for this device

IV. Device Description

The SOMATOM go.Platform is comprised of the following 4 CT scanners and optional mobile workflow:

SOMATOM go.Up ●
SOMATOM go.Now ●
SOMATOM go.Top ●
o SOMATOM go.All
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
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
O Finalization of exam (close patient)

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NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot O trigger a scan or radiation release.
The software version for the SOMATOM go.Platform, syngo CT VA20 (SOMARIS/10 syngo CT VA20), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform SOMARIS/10 syngo CT VA20 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 VA20 (SOMARIS/10 syngo CT VA20) is an update to software version syngo CT VA10A (SOMARIS/10 syngo CT VA20) which was cleared for the predicate devices, 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:

Subject Device: SOMATOM qo. Now and SOMATOM go.Up: Modified from the primary

predicate device SOMATOM go.Now and SOMATOM go.Up to support the following:

1. Modified Indication for Use Statement
1. New/Modified Hardware
- Modified Patient Table .
- . New Injector Arm (optional)
Software version SOMARIS/10 syngo CT VA20 3)
- Modified software to support CT Intervention from ICS console ●
- Modified software to support CT Intervention as optional mobile workflow with Scan&GO ●
- . Modified Inline Vessel Ranges - Cardio CPR (curved planar reformation)
- Modified Dynamic Serio Mode for perfusion .
- Modified basic post processing features o
- o Modified HD FoV
1. Update 510(k) Information provided as Appendix H

Subject Devices: SOMATOM go.All and SOMATOM go.Top Scanners: Further

developments of the primary predicate device SOMATOM go.Now and SOMATOM go.Up CT scanners including the following modifications:

New Marketing Name: SOMATOM go.All and SOMATOM go.Top 1)
1. Modified Indications for Use Statement
1. New/Modified Hardware
- Modified Patient Table ●
- New Injector Arm (optional) .
- . Modified Generator
- Modified Stellar Detector
- 0 Modified X-Ray Tube
- o New Iniector Arm (optional)
Software version SOMARIS/10 syngo CT VA20 4)
- Modified software to support CT Intervention from ICS console ●
- Modified software to support CT Intervention as optional mobile workflow with Scan&GO ●
- Modified Inline Vessel Ranges Cardio CPR (curved planar reformation) ●
- Modified Dynamic Serio Mode for perfusion ●
- Modified basic post processing features
- Modified HD FoV
- Modified High Power 70 ●
- o Modified CARE kV
- Modified Adaptive Cardio Sequence o
- Support of TwinBeam Scan Mode (SOMATOM go.Top only)

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. Support of Inline DE (Radial Ranges, Parallel Ranges) (SOMATOM go.Top only)
Subject Device: Scan&GO Mobile Workflow (optional): Further developments of mobile medical application software Scan&GO supported by SOMATOM go.Platform CT Scanner Systems including the following modifications:
1. Software version SOMARIS/10 syngo VA20
- Optional new workflow - Guide&GO CT-Guided Intervention

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. As cleared in the predicate device, the subject device SOMATOM go.Now CT scanner is available in a 16 row 32 slice configuration and SOMATOM go.Up CT scanner is available in a 32 row 64 slice configuration. The configurations for the subject devices SOMATOM go.Now and SOMATOM go.Up will remain unchanged from the predicate device.

The subject device SOMATOM go.All scanner will be available in a 32 row 64 slice configuration and the SOMATOM go.Top scanner will be available in 64 row 128 slice configuration. A summary of the differences between the subject device CT scanner configurations is provided as Table 1 and Table 2 below.

Subject Device Comparison
Key specifications	SOMATOM go.Now	SOMATOM go.Up
Physical Rows	16	32
Slice width (mm)	0.7	0.7
z coverage (mm)	11.2	22.4
Rotation time (s)	0.8, 1.0, 1.5	0.8, 1.0, 1.5
FoV (cm)	50	50
Max scan range (cm)	125	160
	160
Bore size (cm)	70	70
Gantry tilt	Not available	Available
Table Vertical Movement	Standard: NoOptional: YES	Available
Table Load (kg)	Table Load: 160Optional: 227	227
Power (kW)	32	32
XTA X-ray Tube	Chronon	Chronon
Tube heat capacity (MHU)	3.5	3.5
Recon speed (images/s)	9 (optional 13)	13
Detector width	11.2 mm	22.4 mm
Iterative Reconstruction Methods	SAFIRE, iMAR	SAFIRE, iMAR
Spiral Scan	Available	Available

Table 1: SOMATOM go.Now and SOMATOM go.Up comparable properties

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Subject Device Comparison
Key specifications	SOMATOM go.All	SOMATOM go.Top
Physical Rows	32	64
Slice width (mm)	0.7	0.6
z coverage (mm) / Detector width	22.4	38.4
Rotation time (s)	0.33, 0.5, 1.0	0.33, 0.5, 1.0
FoV (cm)	50	50
Max scan range (cm)	160	160
Bore size (cm)	70	70
Gantry tilt	Available	Available
Table Vertical Movement	Available	Available
Table Load (kg)	Table Load: 227Optional: 300	Table Load: 227Optional: 300
Power (kW)	75	75
XTA X-ray Tube	Athlon	Athlon
Tube heat capacity (MHU)	>=6	>=6
Iterative Reconstruction Control Unit	IRS-1c	IRS-1c
Iterative Reconstruction Methods	SAFIREiMAR	SAFIREiMAR
Spiral Scan	Available	Available

Table 2: SOMATOM go.All and SOMATOM go.Top comparable properties

V. Indications for Use

SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All and SOMATOM go.Top:

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

Scan&GO:

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

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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 when compared to the predicate devices.

Software version SOMARIS/10 syngo CT VA20 supports software features such as 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.Platform 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-Rav 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
. Support of interfaces to access optional post-processing applications
Patient table configurations ●
. Tin filtration technology
Stellar detector technology
High Power 80 (High mA@low kV) .
Support of optional wired/wireless Remote Scan Control (RSC) ●
o Support of the optional Scan &GO mobile workflow

The following technological differences exist between the subject device SOMATOM go.Now and SOMATOM go.Up and the predicate device SOMATOM go.Now and SOMATOM qo.Up:

Software version SOMARIS/10 syngo CT VA20 .
New iniector arm (optional) ●
Support of Intervention Workflow for Scan&GO

The following technological differences exist between the subject device SOMATOM go.All and SOMATOM go.Top and the predicate device SOMATOM go.Now and SOMATOM go.Up:

Software version SOMARIS/10 syngo CT VA20 .
Athlon X-ray Tube .
Long scan range
75 kW maximum power Generator ●
High Power 70 ●
New injector arm .
Software version SOMARIS/10 syngo CT VA20
Support of Intervention Workflow for Scan&GO ●

The following technological differences exist between the subject device Scan&GO and the predicate device Scan&GO:

Software version SOMARIS/10 syngo CT VA20
A tabular summary of the differences between the predicate and subject devices is provided as Table 3, Table 4 and Table 5 below:

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Table 3: Comparison of Technological Characteristics for SOMATOM go.Now and SOMATOM go.Up

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Table 4: Comparison of Technological Characteristics for SOMATOM go.All and SOMATOM go.Top

Property	Subject DeviceSOMATOM go.All	Subject DeviceSOMATOM go. Top	Primary PredicateDeviceSOMATOM go.NowSOMATOM go.Up(K163296)
Type of CTScanner	whole body X-raycomputed tomographyscanner	whole body X-raycomputed tomographyscanner	whole body X-raycomputed tomographyscanner
System	continuously rotating tubedetector system	continuously rotating tubedetector system	continuously rotating tubedetector system
Hardware	high voltage generatorwith max power 75kW	high voltage generatorwith max power 75kW	high voltage generatorwith max power 32kW
X-Ray Tube	Athlon	Athlon	Chronon
kV Steps	70 kV / 80 kV / 90 kV /100 kV / 110 kV / 120 kV/ 130 kV / 140 kV	70 kV / 80 kV / 90 kV /100 kV / 110 kV / 120 kV/ 130 kV / 140 kV	80kV, 110kV,130kV
SelectivePhoton Shield	Tin Filter Technology	Tin Filter Technology	Tin Filter Technology
single sourcedual energy	N/A	Split Filter Technology(TwinBeam Dual Energy)	N/A
HMI & GantryDisplay	realized as wirelesstablet mobile medicalapplication software,remote scan control(wired/wireless)	realized as wirelesstablet mobile medicalapplication software,remote scan control(wired/wireless)	realized as wireless tabletmobile medicalapplication software,remote scan control(wired/wireless)
SoftwareOperatingSystem	Windows basedSOMARIS/10 syngo CTVA20	Windows basedSOMARIS/10 syngo CTVA20	Windows basedSOMARIS/10 syngo CTVA10A

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Property	Subject DeviceSOMATOM go.All	Subject DeviceSOMATOM go. Top	Primary PredicateDeviceSOMATOM go.NowSOMATOM go.Up(K163296)
SoftwareFeatures	Basic Post ProcessingViewer	Basic Post ProcessingViewer	Basic Post ProcessingViewer
	Interface for AdvancedPost ProcessingApplication	Interface for AdvancedPost ProcessingApplication	Interface for AdvancedPost ProcessingApplication
	Interface for Plugin (forfuture advancedvisualization tools andextended functionalities)	Interface for Plugin (forfuture advancedvisualization tools andextended functionalities)	Interface for Plugin (forfuture advancedvisualization tools andextended functionalities)
	Interface to support anoptional mobile workflowcontrol applicationsoftware	Interface to support anoptional mobile workflowcontrol applicationsoftware	Interface to support anoptional mobile workflowcontrol applicationsoftware
	Image Reconstruction	Image Reconstruction	Image Reconstruction
SoftwareFeatures	IT Hardening	IT Hardening	IT Hardening
	Data Exchange withexternal SW client(Teamplay) – allows tocopy or transfer scanprotocols from / to othersystems	Data Exchange withexternal SW client(Teamplay) – allows tocopy or transfer scanprotocols from / to othersystems	Data Exchange withexternal SW client(Teamplay) –allows to copy scanprotocols from othersystems
	SAFIREiMAR	SAFIREiMAR	SAFIREiMAR
IterativeReconstructionMethods	SAFIREiMAR	SAFIREiMAR	SAFIREiMAR

Table 5: Scan&GO Mobile Workflow

	SOMATOM go.Platform Scanner	SOMATOM go.Platform Scanner
TechnologicalCharacteristic	Frontend:Subject DeviceScan&GO (VA20)	Frontend:Predicate DeviceScan&GO (VA10)(K163297)
Software OperatingPlatform	Windows based SOMARIS/10syngo CT VA20 operating software	Windows based SOMARIS/10 syngoCT VA10A operating software
Supported Hardware	Detached commercially availabletablet that meets certain minimumrequirements.	Detached commercially availabletablet that meets certain minimumrequirements.
Operating SoftwarePlatform	Windows 10 and .Net is required asoperating platform	Windows 10 and .Net is required asoperating platform
Connection to thescanner	Wi-Fi connection	Wi-Fi connection
TechnologicalCharacteristic	SOMATOM go.PlatformScanner	SOMATOM go.Platform Scanner
	Frontend:Subject DeviceScan&GO (VA20)	Frontend:Predicate DeviceScan&GO (VA10)(K163297)
User Interface	Siemens delivers a tablet providedby external supplier as part of therespective SOMATOM go.PlatformCT system. Alternatively, theapplication supports a commerciallyavailable tablet that meets certainminimum requirements. This has nospecific modification compared toother commercially available tablet.	Siemens delivers a tablet provided byexternal supplier as part of therespective SOMATOM go. Platform CTsystem. Alternatively, the applicationsupports a commercially availabletablet that meets certain minimumrequirements. This has no specificmodification compared to othercommercially available tablet.
Software Function	Scan parameter display	Scan parameter display
	Patient table position display	Patient table position display
	Tools and instruction message area	Tools and instruction message area
	Patient table position planning area	Patient table position planning area
	Physiological data display	Physiological data display
	Patient data display	Patient data display
	Information icons display	Information icons display
	display of acquired topogram andtomogram images	display of acquired topogram andtomogram images
	planning of tomogram scan	planning of tomogram scan
	finalization of exam	finalization of exam
	Selection of patients	Selection of patients
	Support of interventional workflow	N/A
	Selection of pre-defined protocols	Selection of pre-defined protocols

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Any differences in technological characteristics do not raise different questions of safety and effectiveness. Siemens believes that the subject devices are substantially equivalent to the predicate devices. Testing and validation is completed. Test results show that the subject devices are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.

VII. Performance Data

Non Clinical Testing

Non-clinical test (integration and functional) including phantom tests were conducted for the subject devices during product development. The modifications described in this Premarket Notification are supported with verification and validation testing. Siemens attests conformance to the following performance standards: ISO 14791, NEMA XR-29, IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NEMA XR-25, and DICOM 3.1-3.20, NEMA XR-28, AAMI/ANSI ES60601-1, IEC 62366.

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Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the subject devices in accordance with the following standards: IEC 60601-2-44, IEC 60601-1-3, IEC 60601-1-6, and IEC 60601-1-2. Completed Form FDA 3654 are provided within this submission.

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 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 Healthcare conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse 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 quidance '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 ●
Adiacent 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 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

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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.
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 test performed meet the pre-determined acceptance criteria and demonstrate that Scan&GO is safe and effective for 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 whether screening 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.

A comparison of different technological characteristics and image quality metrics relevant to the task of lung scanner screening was performed for each new subject device. The results of these comparisons support the substantial equivalence for the new subject device CT scanners for the task of low dose CT lung cancer screening.

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, 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 nonclinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the SOMATOM qo.Platform should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM go.Platform 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,

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Siemens believes that the data generated from the SOMATOM go.Platform 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.