Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software update for a CT system focusing on workflow, image reconstruction, and post-processing interfaces, without mentioning AI or ML.

Therapeutic

No
This device is a diagnostic imaging system (CT scanner) used to generate images for aid in diagnosis, treatment preparation, and radiation therapy planning, not to directly treat a disease or condition.

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."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the submission is for a Computed Tomography (CT) X-ray System, which includes both hardware (tube-detector system, gantry, patient table) and software components. While the submission focuses on a software update and includes optional software components like Scan&GO, the core device is a hardware-based CT scanner.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states that the system is for generating and processing cross-sectional images of patients using x-ray transmission data. The images are used by trained personnel as an aid in diagnosis, treatment preparation, and radiation therapy planning. This involves imaging the patient directly, not analyzing samples taken from the patient.
Device Description: The device is described as a Computed Tomography (CT) X-ray System. CT scanners are imaging devices that use X-rays to create cross-sectional images of the body.
Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any analysis on biological specimens.

The device is a medical imaging system used for diagnostic purposes, but it operates by imaging the patient's body directly, which is not the function of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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

JAK

Device Description

Siemens intends to update software version, SOMARIS/10 syngo CT VA40 for Siemens SOMATOM Computed Tomography (CT) Scanner Systems with unmodified mobile workflow options. This update also includes optional hardware for CT guided intervention workflow for the X. platform supporting CT Scanner Systems.

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

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

SOMATOM X. platform is comprised of the following 2 CT scanners and optional mobile workflow:

SOMATOM X.cite
SOMATOM X.ceed (new CT Scanner Model)
Scan&GO Software (optional mobile workflow component) .

The subject device SOMATOM go. platform and SOMATOM X. platform with SOMARIS/10 syngo CT VA40 are Computed Tomography X-ray Systems which feature one continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go. platform and SOMATOM X. platform with software SOMARIS/10 syngo CT VA40 produces CT images in DICOM format. These images can be used by trained staff for post-processing applications commercially distributed by Siemens Medical Solutions USA, Inc. and other vendors. These images aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.

The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of the subject device platform CT scanners. Scan&GO can be operated on a Siemens provided various tablet hardware or personal computer that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet or personal computer with Wi-Fi connection that meets certain minimum requirements:

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

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

The software version, syngo CT VA40 (SOMARIS/10 syngo CT VA40), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The software platform provides a software plugin interface that allows for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.

Software version syngo CT VA40 (SOMARIS/10 syngo CT VA40) is an update to software version syngo CT VA30A (SOMARIS/10 syngo CT VA30) which was cleared for the primary predicate device SOMATOM X.cite in K200524 and supports the same plugin interfaces for the optional Scan&GO mobile workflow and integration of post-processing tasks as the predicate devices.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Computed Tomography (CT)

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained physician, trained staff

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

Not Found

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

Non-Clinical Testing:
Non-clinical test (integration and functional) including phantom tests were conducted for the SOMATOM go. platform CT Scanner Systems and SOMATOM X. platform during product development. The modifications described in this Premarket Notification were supported with this verification and validation testing.

Testing will be covered by 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 Validation test:
- Acceptance test (workflow and user manual test)
- Test to support standards and regulations
System Verification test:
- System Integration Test (functional)
- Functionality verification
- Image Quality (IQ) Evaluation

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 performed as bench tests to support new device or device modification:

MyNeedle Laser:
- Bench Testing - The results of the accuracy test with a simulated clinical workflow and test setup show that defined accuracy level can be achieved.
- Bench Testing - A comparison to the essential workflow steps was performed to demonstrate reduction in steps.
UHR imaging-Ultra High Resolution: Bench Testing - High Resolution across the whole FoV was evaluated and met the predetermined acceptance criteria.
Cardiac CT imaging - Motion artifact reduced ECG-gated imaging: Phantom Testing - Testing based on an andromorphic motion heart phantom (to mimic clinical performance) was performed to demonstrate support of the clinical claims.
Motion Artifact Reduced Non-Gated Imaging: Phantom Testing - Testing was completed based on an andromorphic motion heart and respiratory phantom to support the clinical claims based on technical phantom measurements, which are clinically realistic.
Cardiac BestPhase: Bench Testing - The automatic calculation of the cardiac reconstruction phase with minimized visible motion based on an ECG gated data set was completed. The testing demonstrated the feature met the requirements.
Equivalence of essential image quality parameters: Image Quality - The performed bench test provides substantial equivalence discussion about essential image quality parameters between SOMATOM X.ceed and SOMATOM X.cite - A number of tests were performed and evaluated (e.g. Image contrast values, image noise, contrast to noise ratio (CNR), noise power spectra).
Lung Cancer Screening: Bench Testing - Lung Cancer Screening Technological Parameters Comparison to support the new CT Scanner Model SOMATOM X.ceed was completed. This supports the indications for use accordingly for the new CT model.

Wireless and Wireless Coexistence Testing:
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.

Key Results:
The test results show that all the software specifications have met the predetermined acceptance criteria. Verification testing of the device was found acceptable to support the claim of substantial equivalence. The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the SOMATOM go. and SOMATOM X. platforms should perform as intended in the specified use conditions.

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.

K200524

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.

K200524, K190578

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 shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

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

Re: K211373

Trade/Device Name: SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite SOMATOM X.ceed, Scan&GO Software

Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: April 30, 2021 Received: May 4, 2021

Dear Alaine Medio:

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

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

August 27, 2021

1

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

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

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

Sincerely,

Michael D. O'Hara
For

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

Enclosure

2

Indications for Use

510(k) Number (if known) K211373

Device Name

SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite, SOMATOM X.ceed, Scan&GO Software

Indications for Use (Describe)

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

The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations *

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

3

510(k) Summary

FOR

SOMATOM GO. PLATFORM AND SOMATOM X. PLATFORM

CT Scanner Systems

- Software version SOMARIS/10 syngo CT VA40

Submitted by: Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville. TN 37932 Date Prepared: February 21, 2021

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

I. Submitter

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

Importer/Distributor

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

Location of Manufacturing Site (1) Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335

Location of Manufacturing Site (2) SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Registration Number: 3003202425

Contact Person: Alaine Medio Regulatory Affairs Siemens Medical Solutions USA, Inc. (865) 206-0337 (work cell) (865) 218-3019 FAX alaine.medio@siemens-healthineers.com

4

II. Device Name and Classification

| Product Names: | SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All,
SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro
SOMATOM X.cite, SOMATOM X.ceed, Scan&GO Software |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Names: | SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All,
SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro
SOMATOM X.cite, SOMATOM X.ceed, Scan&GO Software |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | JAK |

III. Predicate Device

Primary Predicate Device:

Trade Names:	SOMATOM X.cite, Scan&GO
510(k) Number:	K200524
Clearance Date:	April 01, 2020
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subject device design.

Reference Device:

Trade Name:	SOMATOM go.Top, SOMATOM go.Open Pro
510(k) Number:	K200524
Clearance Date:	April 01, 2020
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subject device design.

Note: K200524 was a bundle submission with various Siemens CT Scanner Systems, including SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite and Scan&GO software.

5

Reference Device:
Trade Name:	SOMATOM Force
510(k) Number:	K190578
Clearance Date:	June 27, 2019
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subject
device design.

In this submission, the primary predicate device SOMATOM X.cite including Scan&GO and the reference devices SOMATOM go.Top and SOMATOM Force are being used, to demonstrate substantial equivalence of technological characteristics.

IV. Device Description

Siemens intends to update software version, SOMARIS/10 syngo CT VA40 for Siemens SOMATOM Computed Tomography (CT) Scanner Systems with unmodified mobile workflow options. This update also includes optional hardware for CT guided intervention workflow for the X. platform supporting CT Scanner Systems.

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

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

SOMATOM X. platform is comprised of the following 2 CT scanners and optional mobile workflow:

SOMATOM X.cite
SOMATOM X.ceed (new CT Scanner Model)
Scan&GO Software (optional mobile workflow component) .

The subject device SOMATOM go. platform and SOMATOM X. platform with SOMARIS/10 syngo CT VA40 are Computed Tomography X-ray Systems which feature one continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM go. platform and SOMATOM X. platform with software SOMARIS/10 syngo CT VA40 produces CT images in DICOM format. These images can be used by trained staff for post-processing applications commercially distributed by Siemens Medical Solutions USA, Inc. and other vendors. These images aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.

6

The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of the subject device platform CT scanners. Scan&GO can be operated on a Siemens provided various tablet hardware or personal computer that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet or personal computer with Wi-Fi connection that meets certain minimum requirements:

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

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

The software version, syngo CT VA40 (SOMARIS/10 syngo CT VA40), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The software platform provides a software plugin interface that allows for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.

Software version syngo CT VA40 (SOMARIS/10 syngo CT VA40) is an update to software version syngo CT VA30A (SOMARIS/10 syngo CT VA30) which was cleared for the primary predicate devices in K200524 and supports the same plugin interfaces for the optional Scan&GO mobile workflow and integration of post-processing tasks as the predicate devices.

7

V. Indications for Use

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

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

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

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

VI. Comparison of Technological Characteristics with the Predicate Device

The subject devices (SOMATOM go. platform scanners, SOMATOM X. platform scanners and optional Scan&GO mobile workflow software application) provide the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices.

The new syngo CT VA40 software supports the software update of existing CT Scanner Systems SOMATOM go. platform and SOMATOM X.cite. In addition, the software version syngo CT VA40 support the new CT scanner model SOMATOM X.ceed.

The new syngo CT VA40 software reuses all unmodified software features of the legacy software syngo CT VA30 cleared for the primary predicate device SOMATOM X.cite in K200524 and described below in the section "Unmodified Features used in the Subject Devices".

The SOMATOM X. platform also supports an optional laser component for a modified CT guided intervention workflow.

As with the primary predicate device SOMATOM X.cite, the subject devices CT Scanner Systems in combination with Scan&GO support an optional mobile workflow has also been modified to enable a new tablet hardware iPad with iPad OS operating software that support subject device Scan&GO mobile medical application software installation.

SOMARIS/10 syngo CT VA40 is designed to reuse hardware independent extended functionalities and GO technologies provided by Siemens cleared commercially available software applications. The intended use and fundamental scientific technology for these independent software applications are unchanged from their cleared and released software when incorporated for use on the SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite and SOMATOM X.ceed CT scanner systems.

The subject and predicate devices are based on the following same technological elements:

. Scanner Principle- Whole body X-Ray Computed Tomography Scanner

8

System Acquisition Continuously rotating tube detector system ●
Iterative Reconstruction - Support of various iterative reconstruction methods
. Workplaces – Support of workplaces that include reconstruction and image evaluation software
Patient table
Patient table foot switch for movement
Tin filtration technology
Chronon, Athlon or Vectron X-ray Tube
Stellar detector technology
Maximum power Generator
High Power 70, High Power 80 (High mA@low kV)
Iterative Reconstruction Methods
Mobile Medical application Software functionality (Scan&GO)
Mobile workflow (Tablet)
Support of interfaces to access 3D Camera operation for fast patient positioning workflow
Scanner display and control functionality
Remote Scan Control
Support of CT Guided Interventional Workflow - Guide&GO
Optional Injector Arm
Long scan range ●
DirectDensity™ Reconstruction, which provides CT images with an HU-like scaling that is nearly proportional to relative electron density or relative mass density
. Respiratory Scan – Functions and Interfaces

The following technological differences exist between the subject device SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite, SOMATOM X.ceed and the primary predicate device SOMATOM X.cite and the reference device SOMATOM go.Top cleared in K200524:

Software version SOMARIS/10 syngo CT VA40
Additional options for Inline Results and GO technologies
CT guided intervention – modified hardware and software application
Precision Matrix function

The following technological differences exist between the subject device Scan&GO and the predicate device Scan&GO cleared in K200524:

Software version SOMARIS/10 syngo CT VA40
iPad hardware to support mobile workflow options
CT guided intervention – modified software application

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

1) New/Modified Hardware

Table S5-02: Overview of hardware modifications ●

2) Software version SOMARIS/10 syngo CT VA40

Table S5-03: Overview software modifications

9

The configuration table and comparison table use the following terms to describe various technological characteristics in comparison to the predicate device information:

Term	Definition
N/A	The feature is not supported for the subject device
New	The feature is newly supported for Siemens CT Scanners and the subject device
Modified	This feature is modified from the predicate / reference devices
Unmodified	This feature remains unchanged from the predicate device
enabled	This feature is currently supported by other cleared Siemens CT systems or cleared Siemens stand
alone software applications. This feature will be supported for the subject device with software
version SOMARIS/10 syngo CT VA40 and is substantially equivalent compared to the cleared version.

Table S5-01: Overview term definition

Table S5-02: Overview of hardware modifications in comparison to the corresponding predicate devices

| | CT Scanner Systems with
SOMARIS/10 syngo CT
VA40 | Subject Devices | | | | | |
|----|-------------------------------------------------------------------------------------|-----------------------------|-------------------|-------------------|-----------------------------------|-------------------|-------------------|
| | Hardware properties | SOMATOM
go.Now/
go.Up | SOMATOM
go.All | SOMATOM
go.Top | SOMATOM
go.Sim/
go.Open Pro | SOMATOM
X.cite | SOMATOM
X.ceed |
| 01 | CT guided intervention:
myNeedle Laser (part of
myNeedle Companion) | N/A | N/A | N/A | N/A | new | new |
| 02 | Tablet hardware for
Scan&GO - iPad | modified | modified | modified | modified | modified | modified |
| 03 | CT Detector - Fan
geometry | unmodified | unmodified | unmodified | unmodified | unmodified | Modified |
| 04 | UHR imaging-Ultra High
Resolution for sub
millimeter anatomical
structures | N/A | N/A | N/A | N/A | N/A | enabled¹ |
| 05 | Patient Table
Configuration | unmodified | unmodified | unmodified | unmodified | modified | modified |

1Note 1: This feature is cleared in K190578 – SOMATOM Force with SOMARIS/7 and enabled on SOMARIS/10 for the supporting subject devices.

Table S5-03: Overview software modifications of SOMATOM go. platform and SOMATOM X. platform with syngo CT VA40

| | | Subject
Devices | Subject
Device | Subject Device | Subject Devices | Subject Device | Subject Device |
|----|------------------------------------------------------------------------------------|-----------------------------|-------------------|-------------------|-----------------------------------|-------------------|-------------------|
| | | SOMATOM
go.Now/
go.Up | SOMATOM
go.All | SOMATOM
go.Top | SOMATOM
go.Sim/
go.Open Pro | SOMATOM
X.cite | SOMATOM
X.ceed |
| | Software
properties | | | | | | |
| 01 | Precision
Matrix
(10242) (large
image
matrices) | N/A | N/A | enabled1 | enabled1 | enabled1 | enabled1 |
| 02 | CT guided
intervention:
myNeedle
Guide (part of
myNeedle
Companion) | modified | modified | modified | modified | modified | modified |
| 03 | Flex 4D Spiral

Neuro /
Body | N/A | unmodified | unmodified | unmodified | modified | modified |

10

| | | Subject
Devices | Subject
Device | Subject Device | Subject Devices | Subject Device | Subject Device |
|----|-----------------------------------------------------------------------------------------------|-----------------------------|-------------------|--------------------|-----------------------------------|-------------------|-------------------|
| | Software
properties | SOMATOM
go.Now/
go.Up | SOMATOM
go.All | SOMATOM
go. Top | SOMATOM
go.Sim/
go.Open Pro | SOMATOM
X.cite | SOMATOM
X.ceed |
| 04 | CT
projection rea
d-
out frequency

8kHz
imaging | N/A | N/A | N/A | N/A | N/A | modified |
| 05 | Imaging -
Cardio
BestPhase | N/A | unmodified | unmodified | unmodified | unmodified | enabled2 |
| 06 | ADMIRE | N/A | enabled2 | enabled2 | N/A | unmodified | enabled2 |
| 07 | UHR imaging-
Ultra High
Resolution for
sub
millimeter
anatomical
structures | N/A | N/A | N/A | N/A | N/A | enabled1 |
| 08 | Cardiac CT
imaging -
Motion
artifact
reduced ECG-
gated imaging | N/A | unmodified | unmodified | unmodified | unmodified | modified |
| 09 | Motion
artifact
reduced non-
gated imaging | N/A | unmodified | unmodified | unmodified | unmodified | modified |
| 10 | myExam
Satellite | N/A | N/A | modified | modified | modified | modified |

1Note 1: This feature is cleared in K190578 – SOMATOM Force with SOMARIS/7 and enabled on SOMARIS/10 for the supporting subject devices.

²Note 2: This feature is cleared in K200524 – SOMATOM X.cite with SOMARIS/10 and enabled for the supporting subject devices.

A comparison of these modifications with respect to the predicate devices is provided in the "Comparison of Technological Characteristics with the Predicate Device" section below. Software version SOMARIS/10 syngo CT VA40 will be offered as an optional upgrade for the existing SOMATOM CT go. platform Systems and SOMATOM X.cite.

A tabular summary of the comparable hardware properties between the subject devices SOMATOM go. platform and SOMATOM X. platform CT Scanner Systems with software version syngo CT VA40 and the predicate device are listed in Table S5-04 and Table S5-05 below (modifications are in gray shaded sections).

11

| | SOMATOM go. platform - Device Comparison (Single Source Systems) | | | | | | | Hardware Property | Subject Devices | | Primary Predicate
Device |
|----------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------|----------------------------------------|------------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------|
| | Subject Device | | | | | | Primary
Predicate | | SOMATOM X.cite
with syngo CT VA40 | SOMATOM X.ceed
with syngo CT VA40 | SOMATOM X.cite
(K200524)
syngo CT VA30 |
| Hardware Property | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.All | SOMATOM
go.Top | SOMATOM
go.Sim | SOMATOM
go.Open Pro | SOMATOM
X.cite
(K200524) | Scanner | whole body X-ray computed tomography
scanner | whole body X-ray computed tomography
scanner | whole body X-ray
computed tomography
scanner |
| whole body X-ray computed tomography scanner | | | | | | | | Generator
max. power | 90kW/105kW | 105kW/120kW | 105 kW |
| Scanner | Detector
technology | Stellar Infinity | Stellar Infinity | Stellar Infinity | | | | | | | |
| Generator
max. power | 32 kW | 32 kW | 75 kW | 75 kW | 75 kW | 75 kW | 105 kW | Detector
volume coverage | 38.4 mm | 38.4 mm | 38.4 mm |
| Detector
technology | Stellar | Stellar | Stellar | Stellar | Stellar | Stellar | Stellar Infinity | Detector
physical rows | 64 | 64 | 64 |
| Detector
volume coverage | 11.2 mm | 22.4 mm | 22.4 mm | 38.4 mm | 19.2 mm | 38.4 mm | 38.4 mm | Detector
slice width | 0.6 mm | 0.6 mm | 0.6 mm |
| Detector
physical rows | 16 | 32 | 32 | 64 | 32 | 64 | 64 | Detector
DAS channel No. | 840 | 920 | 840 |
| 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
image slices | 128 | 128 | 128 |
| Detector
DAS channel No. | 768 | 768 | 768 | 840 | 920 | 920 | 840 | Tube
Technology | Vectron | Vectron | Vectron |
| Detector
image slices | 32 | 64 | 64 | 128 | 64 | 128 | 128 | Tube
kV steps | (in 10kV steps)
70 kV to 150kV | (in 10kV steps)
70 kV to 150kV | (in 10kV steps)
70 kV to 150kV |
| Tube
Technology | Chronon | Chronon | Athlon | Athlon | Athlon | Athlon | Vectron | Tube
max. current | 10 mA ~ 1100 mA; ≤ ±20% for 90 kW
10 mA ~ 1200 mA; ≤ ±20% for 105 kW | 10 mA ~ 1200 mA; ≤ ±20% for 105 kW
10 mA ~ 1300 mA; ≤ ±20% for 120 kW | 1200 mA |
| Tube
kV steps | 80kV, 110kV, 130kV | | | (in 10kV steps)
70 kV to 140 kV | | | (in 10kV steps)
70 kV to 150 kV | Tube
tube focus | 0.6 x 0.7 mm
0.8 x 1.1 mm | min. 0.6 x 0.7 mm (w/o comb)
min. 0.4 x 0.5 mm (with comb) | 0.6 x 0.7 mm
0.8 x 1.1 mm |
| Tube
max. current | 400 mA | 400 mA | 825 mA | 825 mA | 825 mA | 825 mA | 1200 mA | Tube
heat capacity | higher than 30 MHU | higher than 30 MHU | higher than 30 MHU |
| 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 | 0.6 x 0.7
0.8 x 1.1 | Gantry
bore size | 82 cm | 82 cm | 82 cm |
| Tube
heat capacity | 3.5 MHU | 3.5 MHU | 6 MHU | 6 MHU | 6 MHU | 6 MHU | >30 MHU | Gantry
FoV | 50 cm | 50 cm | 50 cm |
| Gantry
bore size | 70 cm | 70 cm | 70 cm | 70 cm | 85 cm | 85 cm | 82 cm | Gantry
rotation time (sec) | 0.3s/360°, 0.5s/360°, 1.0s/360° | 0.25s/360°, 0.3s/360°, 0.5s/360°,
1.0s/360° | 0.3, 0.5, 1.0 |
| Gantry
Scan FoV | 50 cm | 50 cm | 50 cm | 50 cm | 60 cm | 60 cm | 50 cm | Gantry
Tilt [degree] | '+/- 30° opt
+/- 25° std | '+/- 30° opt
+/- 25° std | +/- 25 |
| Gantry
rotation time (sec) | | 0.8, 1.0, 1.5 | | 0.33, 0.5, 1.0 | | 0.35, 0.5, 1.0 | 0.3, 0.5, 1.0 | Patient Table
type | Vario RT: 1600mm,
Vario 2: 2000mm
Vitus: 2000mm | Vario RT: 1600mm,
Vario 2.D: 2000mm,
Vitus: 2000mm | Vario RT: 1600mm,
Vario 2: 2000mm |
| Gantry
Tilt [degrees] | N/A | +/-25 | +/-25 | +/-25 | +/-25 | +/-25 | +/-25 | Max. Scan length
Topogram | VARIO RT: 1680 mm
Vario 2: 2080 mm
Vitus: 2080 mm | VARIO RT:
1680 mm
Vario 2.D:
2080 mm
Vitus:
2080 mm | VARIO RT: 1680 mm
Vario 2: 2080 mm |
| Patient Table
type | Vector:
1250 mm
Vario 1/Vario
RT: 1600 mm
with table
extension | Vario 1 (1600 mm, Vario 2 (2000m and
Vario RT: 1600 mm with table extension | | | Vario 2 (2000mm and
Vario RT: 1600 mm with
table extension | | Vario RT: 1600
mm with table
extension
Vario 2: 2000
mm with table
extension | Max. Scan length
Image acquisition | VARIO RT:
1600 mm
Vario 2:
2000 mm
Vitus:
2000 mm | VARIO RT:
1600 mm
Vario 2.D:
2000 mm
Vitus:
2000 mm | VARIO RT:1600 mm
Vario 2: 2000 mm |
| 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 | Spectral filtration
Option* | Combined Split Filter / Tin Filter
supported, plus extra Tin Filter | Combined Split Filter / Tin Filter
supported, plus extra Tin Filter | Combined Split Filter /
Tin Filter supported,
plus extra Tin Filter |
| 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 | 3D Camera | supported | supported | supported |
| 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
supported, plus
extra Tin Filter | High Power 70
(@70kV) | 90kW Gen. @70kV = 1100mA
105kW Gen. @70kV = 1200mA | 105kW Gen. @70kV = 1200mA
120kW Gen. @70kV = 1300mA | 1100 mA
1200 mA |
| 3D Camera | N/A | | | supported | | | supported | High Power 80
(@80KV) | 90kW Gen. @80kV = 1100mA
105kW Gen. @80kV = 1200mA | 105kW Gen. @80kV = 1200mA
120kW Gen. @80kV = 1300mA | 1100 mA
1200 mA |
| High Power 70 (@70kV) | N/A | N/A | 825 mA | 825 mA | 825 mA | 825 mA | 1200 mA | | | | |
| High Power 80 (@80kV) | N/A | N/A | 825 mA | 825 mA | 825 mA | 825 mA | 1200 mA | | | | |
| Respiratory
Gating | | Anzai - AZ, Varian - RGSC | | | | Anzai - AZ, Varian - RGSC | | Anzai - AZ, Varian
– RGSC | | | |
| Gating
sensor | | | | | | | | | | | |

Table S5-04: SOMATOM go. platform comparable hardware properties

12

Table S5-05: SOMATOM X. platform comparable hardware properties (modified)

13

| Laser supported workflow | Laser in combination with FAST Isocentering visualize coordinates for patient isocenter position.
myNeedle Laser visualize coordinates for intervention | Laser in combination with FAST Isocentering visualize coordinates for patient isocenter position.
myNeedle Laser visualize coordinates for intervention | Laser in combination with FAST Isocentering visualize coordinates for patient isocenter position |

--------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------

The tabular summary of the comparable software properties between the subject devices with software version SOMARIS/10 syngo CT VA40 and the predicate devices are listed in Table S5-06 below (modifications are in gray shaded sections).

Table S5-06: SOMATOM go. platform and SOMATOM X. platform comparable software properties

	Subject Device	Predicate Device (K200524)
	SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite, SOMATOM X.ceed	SOMATOM X.cite
Software Property
	syngo CT VA40	syngo CT VA30
	Windows based	Windows based
Operating System	SOMARIS/10 syngo CT VA40 (with additional
software options)	SOMARIS/10 syngo CT VA30A
	syngo Acquisition Workplace (AWP)	syngo Acquisition Workplace (AWP)
	syngo Viewing, syngo Filming and syngo Archiving
& Networking	syngo Viewing, syngo Filming and syngo Archiving
& Networking
Acquisition Workplace	Image Reconstruction	Image Reconstruction
	2nd Acquisition Workplace supported with
myExam Satellite	No 2nd Acquisition Workplace supported
Stellar Detector	Stellar detector firmware supported	Stellar detector firmware supported
Teamplay	Support teamplay Protocols	Support teamplay Protocols
	Protocols for Radiation Therapy Planning
support patient marking Protocol supporting contrast bolus-triggered
data acquisition Contrast media protocols Pediatric Protocols Flex Dose Profile TwinBeam DE TwinSpiral DE Flex 4D Spiral Protocols that allow scanning with support of
an 3rd party respiratory gating system (ANZAI,
Varian RGSC)	Protocols for Radiation Therapy Planning
support patient marking Protocol supporting contrast bolus-triggered
data acquisition Contrast media protocols Pediatric Protocols Flex Dose Profile TwinBeam DE TwinSpiral DE Flex 4D Spiral Protocols that allow scanning with support
of an 3rd party respiratory gating system
(ANZAI, Varian RGSC)
Protocols
	Advanced reconstruction tools supported:	Advanced reconstruction tools supported:
	Spectral Recon (Dual Energy Reconstruction) Inline Results DE SPP (Spectral Post-
Processing) Inline Results DE Ranges (Parallel/Radial) /
Inline DE	Spectral Recon (Dual Energy Reconstruction) Inline Results DE SPP (Spectral Post-
Processing) Inline Results DE Ranges (Parallel/Radial) /
Inline DE
Recon&GO - Advanced
Reconstruction.
	Subject Device	Predicate Device (K200524)
Software Property	• SOMATOM go.Now,
• SOMATOM go.Up,
• SOMATOM go.All,
• SOMATOM go.Top,
• SOMATOM go.Sim,
• SOMATOM go.Open Pro,
• SOMATOM X.cite,
• SOMATOM X.ceed	• SOMATOM X.cite
	syngo CT VA40	syngo CT VA30
Post-Processing plug in functions	enabled via software interface Recon&GO - Inline Results
(various methods of cleared software applications	enabled via software interface Recon&GO - Inline Results
various methods of cleared software applications
Cybersecurity	IT Hardening	IT Hardening
HD FoV	HD FoV 4.0	HD FoV 4.0
Standard technologies	• FAST Features
• CARE Features
• GO technology	• FAST Features
• CARE Features
• GO technology
CT Guided Intervention	Guide&GO or
myNeedle Guide
(Note: Guide&GO is not supported by SOMATOM X.ceed)	Guide&GO
DirectDensity™	DirectDensity™
(including relative electron density and relative mass density)	DirectDensity™
(including relative electron density and relative mass density)
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 gating scan modes	Respiratory gated spiral and respiratory triggered sequence scan modes	Respiratory gated spiral and respiratory triggered sequence scan modes
Iterative Reconstruction Methods	iMAR, ADMIRE
• (ADMIRE is enabled for go.All, go.Top, X.Cite and X.Ceed and not supported by SOMATOM go.Now, go.Up, go.Sim, go.Open Pro)	iMAR, ADMIRE
Precision Matrix	Precision Matrix resolution
support image matrix sizes of 512 x 512 pixels, 768x768 pixels and 1024x1024 pixels (auto mode supported)
(not for go.Now, go.Up and go.All)	Matrix resolution 512x512 pixels
(auto mode not supported)
CaScoring	Offers images which can be used for calcium scoring, independent from tube voltage kV and beam filtration settings based on a dedicated	Offers images which can be used for calcium scoring, independent from tube voltage kV and beam filtration settings based on a dedicated

14

Any differences in technological characteristics do not raise different questions of safety and effectiveness. 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 safety and effectiveness and therefore are substantially equivalent to the predicate devices.

15

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 and SOMATOM X. platform during product development. The modifications described in this Premarket Notification were supported with this verification and validation testing.

Testing will be covered by 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 Validation test:

Acceptance test (workflow and user manual test) ●
Test to support standards and regulations ●

System Verification test:

System Integration Test (functional) ●
. Functionality verification
Image Quality (IQ) Evaluation

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 were also performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in table S5-07 below.

| Feature/Non-Clinical Supportive

Testing	Testing Performed
MyNeedle Laser	Bench Testing - The results of the accuracy test with a simulated clinical workflow and test setup show that defined accuracy level can be achieved.
MyNeedle Laser	Bench Testing - A comparison to the essential workflow steps was performed to demonstrate reduction in steps.
UHR imaging-Ultra High
Resolution	Bench Testing - High Resolution across the whole FoV was evaluated and met the predetermined acceptance criteria.
Cardiac CT imaging - Motion
artifact reduced ECG-gated
imaging	Phantom Testing - Testing based on an andromorphic motion heart phantom (to mimic clinical performance) was performed to demonstrate support of the clinical claims.
Motion Artifact Reduced
Non-Gated Imaging	Phantom Testing - Testing was completed based on an andromorphic motion heart and respiratory phantom to support the clinical claims

Table S5-07: Non-Clinical Performance Testing

16

| Feature/Non-Clinical Supportive

Testing	Testing Performed
	based on technical phantom measurements, which are clinically
realistic.
Cardiac BestPhase	Bench Testing - The automatic calculation of the cardiac
reconstruction phase with minimized visible motion based on an ECG
gated data set was completed. The testing demonstrated the feature
met the requirements.
Equivalence of essential
image quality parameters	Image Quality - The performed bench test provides substantial
equivalence discussion about essential image quality parameters
between SOMATOM X.ceed and SOMATOM X.cite - A number of tests
were performed and evaluated (e.g. Image contrast values, image
noise, contrast to noise ratio (CNR), noise power spectra)
Lung Cancer Screening	Bench Testing - Lung Cancer Screening Technological Parameters
Comparison to support the new CT Scanner Model SOMATOM X.ceed
was completed. This supports the indications for use accordingly for
the new CT model.

A list of recognized and general consensus standards considered for the subject devices is provided as Table S5-08 and Table S5-09 below.

| 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 |
| 07/06/2020 | 12-325 | NEMA | XR 25-2019 | 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 |
| 06/27/2016 | 5-40 | ANSI AAMI ISO | 14971:2007/(R)2010
(Corrected 4 October
2007) | 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 |
| 12/23/2016 | 5-114 | ANSI AAMI IEC | 62366-1:2015 | Medical devices - Part 1: Application of
usability engineering to medical devices |

Table S5-08: Recognized Consensus Standards

17

| Date of
Recognition | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
|------------------------|-----------------------|----------------------------------------|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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)]
Note: Requirements according to IEC
60825-1:2014 (Ed.3.0) are implemented. |
| 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)] |
| 12/23/2019 | 12-328 | IEC | 61223-3-5 Edition 2.0
2019-09 | Evaluation and routine testing in medical
imaging departments - Part 3-5:
Acceptance tests - Imaging performance of
computed tomography X-ray equipment
[Including: Technical Corrigendum 1 (2006)] |
| 12/23/2019 | 12-309 | IEC | 60601-2-28 Edition
3.0 2017-06 | Medical Electrical Equipment - Part 2-28:
Particular Requirements for The Basic
Safety And Essential Performance Of X-Ray
Tube Assemblies For Medical Diagnosis |
| 06/27/2016 | 12-299 | IEC | 62563-1 Edition 1.1 | Medical electrical equipment - Medical
image display systems - Part 1: Evaluation
methods |

Table S5-09: General Use Consensus Standards

| Standard
Developing
Organization | 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 | Declaration of conformance to FDA recognized
consensus standards. |

18

| Standard
Developing
Organization | Standard
Designation
Number and
Date | Title of Standard | How was Standard Used |
|----------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| | | conformity - Part 1: General
requirements | |
| 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 S5-10 below.

Table S5-10: 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	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

19

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.

Cybersecurity

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.

Wireless and Wireless Coexistence

Siemens SOMATOM CT Scanners conform 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 tablets 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 with IEC60601-2-44.

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 the 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

20

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.

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 lowdose 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 the software specifications have met the predetermined acceptance criteria. Verification 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. and SOMATOM X. platforms should perform as intended in the specified use conditions.

The data included in this submission demonstrates that the SOMATOM go. platform and SOMATOM X. 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, that the data generated from the SOMATOM and SOMATOM X. platform (including the new SOMATOM X.ceed) testing supports a finding of substantial equivalence.