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

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

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

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

Scan&GO:

This 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

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

Single Source CT Sacnner System:

. SOMATOM X.cite
Scan&GO Mobile Medical Application (optional mobile workflow component) ●

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

The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the SOMATOM X.cite CT scanner. Scan&GO can be operated on a Siemens provided tablet or a commercially available tablet that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet that meets certain minimum requirements:

Selection of patients o
O Selection of pre-defined protocols
Scan parameter display O
Patient table position display and gantry tilt parameter display o
Tools and instruction message area, O
o Patient table position planning area
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")
O Interface to support control function for RTP Laser (e.g. LAP Laser)
Control of moodlight functions o
predefined workflow associated question/answer dialog o

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

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

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

New/Modified Hardware

. Table S01: Overview of Hardware modifications supported by software SOMARIS/10 syngo CT VA30

Software version SOMARIS/10 syngo CT VA30

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

Term	Definition
N/A	The feature is not supported for the subject device
New	The feature is newly supported for Siemens CT Scanners and the subject device
Modified	This feature is modified from the previously cleared version
Unmodified	This feature remains unchanged from the predicate device
Enabled	This feature is currently supported by other cleared Siemens CT systems. This featurewill be supported for the subject device with software version SOMARIS/10 syngo CTVA30 and is unmodified from cleared version.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets them for the SOMATOM X.cite CT system and its associated Scan&GO mobile application.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside specific "reported device performance" values in a quantitative format for the entire device. Instead, it describes various tests performed and states that the tests "meet the pre-determined acceptance criteria" and "all of the software specifications have met the acceptance criteria."

However, specific performance aspects are mentioned:

Acceptance Criterion (Inferred from Testing)	Reported Device Performance (Summary)
General
Functionality and Integration	"The general purpose of each tests is to verify and validate the functionality of the subject device modifications." "Testing supports that all software specifications have met the acceptance criteria."
Safety and Effectiveness	"The non-clinical data supports the safety of the device and software verification and validation demonstrates that the subject device SOMATOM X.cite should perform as intended in the specified use conditions." "All test performed meet the pre-determined acceptance criteria and demonstrate that Scan&GO is safe and effective for the intended use."
Substantial Equivalence	"The data included in this submission demonstrates that the SOMATOM X.cite performs comparably to the predicate devices currently marketed for the same intended use." "Testing and validation is completed. Test results show that the subject device SOMATOM X.cite, is comparable to the predicate devices SOMATOM go.Top (K173632) and SOMATOM Force (K190578) in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices."
Specific Features (Non-Clinical Bench Tests)
kV and Filter independent CaScore	"The test results show that performance of special kernel variants Artifical120 and eDDensity and mDDensity is similar or improved within the limits of accuracy of the test com-pared to the respective initial release versions."
Recon&GO - Spectral Recon	"Deviations between the already cleared image processing algorithms in Inline DE and the new technical realization "Spectral Recon" are extremely small and are not expected to have any impact on the diagnostic performance. Residual deviations are a consequence of rounding differences and slight differences in implementation."
TwinSpiral Dual Energy / TwinSpiral DE	"Based on these results it can be stated that the TwinSpiral Dual Energy CT scan mode provides CT-images of diagnostic quality, which are similar to conventional 120kV images in terms of CT-values and image noise at same radiation dose. The mixed images show a slight reduction in the iodine CT-value, but at the same time image noise at same dose is also lower. So in combination the iodine CNR at same radiation dose is comparable between Mixed images and 120kV images."
Flex 4D Spiral - Neuro/Body	"Scan ranges with the new Flex4D Spiral feature can be freely selected within the limits mandated by the scan mode and protocol. The scanned volume was found to be in agreement with the planned scan range for a variety of different tested scan modes, scan lengths and scanners... the irradiated range markers displayed by the scanner acquisition software during the planning of the respective F4DS scans were in good agreement with the exposed area on the film."
DirectDensity	"The conducted test performed demonstrated the subject device's ability to show relative mass or relative electron density images."
HD FoV	"Phantom testing conducted to assess the subject device ability to provide visualization of anatomies outside the standard field of view and that the image quality standards for radiotherapy applications are met."
Contrast media protocol	"Selected Factory Contrast Protocols are within the limits as prescribed by the approved labeling of Ultravist®."
InjectorCoupling	"Correctness of the contrast injection parameters transferred between the CT device and the supported injection devices has been verified."
FAST Integrated Workflow	FAST Isocentering: "Conducted test for the subject device FAST Isocentering demonstrated that there was a lower isocenter deviation for the subject device in comparison to the predicate device." FAST Range: "Conducted test demonstrated that a lower deviation for landmark boundaries for the subject device in comparison to the predicate device."
Electrical Safety & EMC	Compliance with standards: 60601-2-44, 60601-1-2, NEMA PS 3.1 - 3.20, NEMA XR-25, NEMA XR-28, ISO 14971, IEC 62304, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 62366-1, IEC 60825-1, IEC 60601-2-44, IEC 60601-1-3, IEC 60601-1-6, IEC 61223-2-6, IEC 61223-3-5, IEC 60601-2-28, IEC 62563-1.
Wireless Coexistence	"Siemens has considered several measures to address wireless coexistence by design... Tested for Co-Channel, Adjacent Channel, RF Interference, and Separation Distance/Location, ensuring wireless communications were actively transmitting in situations where possible interference may exist." "Scan&GO does not support shared medium access to Siemens Wi-Fi network."

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

The document details various types of testing, but it does not provide specific sample sizes (e.g., number of patients/cases) for the test sets.

Test Sets:
- Non-Clinical Testing: Includes "phantom tests" and "bench tests" (Table S07). No specific sample sizes (number of phantoms or tests) are mentioned for these.
- Customer Use Testing:
  - Internal Clinical Use Test: "The CT scanner customer environment is simulated in Siemens Test Cabins." Customers with clinical expertise are invited to perform tests. No sample size is provided.
  - External Clinical Use Test: "The CT scanner is tested in the environment of the clinic/hospital." Performed with "selected customer before rollout." No sample size is provided.
- NLST (National Lung Screening Trial) Reference: This is cited as supportive data for the lung cancer screening indication, but the device was not tested in this trial. The NLST itself involved over 53,000 subjects.
Data Provenance:
- The testing described is primarily prospective system and software verification and validation conducted by Siemens.
- Country of Origin of Data: Not explicitly stated for Siemens' internal testing, but the manufacturing sites are listed as Forchheim, Germany, and Shanghai, China, suggesting the testing would likely occur in association with these locations or corporate R&D facilities.
- The National Lung Screening Trial (NLST) (referenced for lung cancer screening indication) was conducted in the United States and spanned from 2002 to 2010.

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

For Siemens Internal/External Clinical Use Tests: The document mentions "customers with clinical expertise" for internal testing and "selected customer" [sic] for external testing. However, it does not specify the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish ground truth for these tests. The nature of these tests appears to be more about workflow and functionality validation rather than diagnostic performance against a definitive ground truth.
For the NLST (referenced for lung cancer screening): The NLST used a rigorous process for establishing ground truth, typically involving expert radiologists and follow-up pathology for confirmed malignancies. However, this study was performed independently and not specifically to test the SOMATOM X.cite device. The FDA's reference to NLST is for the clinical literature supporting the indication for use, not for the device's performance validation itself.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth within Siemens' own device performance testing. The clinical use tests described seem to focus on user workflow and system integration rather than diagnostic accuracy requiring multi-reader adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done or described in this document. The device is a CT scanner, not an AI-assisted diagnostic tool for interpretation.
The document describes the CT system's ability to generate images for aid in diagnosis, but it does not include a study on how human readers' performance (e.g., diagnostic accuracy, reading time) improves with the SOMATOM X.cite specifically.
The only reference to an "AI" type feature is "Artificial120" (a kernel for CaScore) and "ADMIRE" (an iterative reconstruction method), but these are features of image processing, not direct AI assistance for human interpretation.

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

The testing described is for a physical medical device (CT scanner) and its associated software, not a standalone algorithm.
The "non-clinical testing" and "bench tests" evaluate the functional and image quality performance of the CT system's hardware and software components in isolation or simulated environments, which could be considered analogous to "standalone" performance for individual features (e.g., the accuracy of DirectDensity™ or Recon&GO), but not for a diagnostic algorithm in a clinical context.

7. The Type of Ground Truth Used

Based on the descriptions:

Bench/Phantom Tests: Ground truth is established by physical phantoms with known properties (e.g., known densities, dimensions, material compositions) and comparisons to established measurements or control values.
Software Verification & Validation: Ground truth is established by software specifications and requirements, and testing verifies that the software functions as designed and meets these predefined criteria.
Clinical Use Tests: Ground truth appears to be based on successful workflow completion and user feedback rather than a definitive diagnostic truth for patient cases.
NLST (reference only): For the lung cancer screening claim, the underlying clinical evidence (NLST) established ground truth through longitudinal follow-up and pathology for confirmed lung cancers. This is external literature, not part of the device's direct performance study.

8. The Sample Size for the Training Set

This document is for a CT scanner system (hardware and software), not specifically for a machine learning or AI model that requires a dedicated "training set."
Therefore, no information on the sample size for a training set is provided or applicable in the context of this 510(k) submission. Iterative reconstruction methods (like ADMIRE) are often developed using traditional signal processing and physics-based models, and while some may incorporate statistical or adaptive elements, they aren't typically described with "training sets" in the same way as deep learning AI.

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

As a "training set" for an AI or machine learning model is not discussed, this question is not applicable based on the provided document.

Summary

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Image /page/0/Picture/10 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

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

Re: K191891

Trade/Device Name: SOMATOM X.cite Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: October 3, 2019 Received: October 4, 2019

Dear Ms. Estes:

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/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

November 6, 2019

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

Sincerely,

For

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

Enclosure

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Indications for Use

510(k) Number (if known)

K191891

Device Name SOMATOM X.cite

Indications for Use (Describe)

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

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

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

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

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Indications for Use

510(k) Number (if known)

K191891

Device Name Scan & Go

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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."

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K191891

510(K) SUMMARY FOR SOMATOM X.CITE - SOFTWARE VERSION SOMARIS/10 syngo CT VA30 Submitted by:

Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Date Prepared: July 12, 2019

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

I. Submitter

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

Importer/Distributor

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

Location of Manufacturing Site (1)

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

Location of Manufacturing Site (2)

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

Contact Person:

Tabitha Estes Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 804-4553 Fax: (865) 218-3019 Email: tabitha.estes@siemens-healthineers.com

II. Device Name and Classification

Product Name:	SOMATOM X.cite
Trade Name:	SOMATOM X.cite
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

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

III. Predicate Device

Primary Predicate Device:
Trade Name:	SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top,
	SOMATOM go.All, Scan&GO
510(k) Number:	K173632
Clearance Date:	April 13, 2018
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: K173632 was a bundle submission with various Siemens CT Scanner Systems. In this submission the predicate devices SOMATOM go.Now, SOMATOM go.Top and Scan&GO are applicable, to demonstrate substantial equivalence of technological characteristics.

Predicate Device:

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

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

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IV. Device Description

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

Single Source CT Sacnner System:

. SOMATOM X.cite
Scan&GO Mobile Medical Application (optional mobile workflow component) ●

Selection of patients o
O Selection of pre-defined protocols
Scan parameter display O
Patient table position display and gantry tilt parameter display o
Tools and instruction message area, O
o Patient table position planning area
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")
O Interface to support control function for RTP Laser (e.g. LAP Laser)
Control of moodlight functions o
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 SOMATOM X.cite will support the following modifications/further developments in comparison to the predicate devices:

1) New/Modified Hardware

. Table S01: Overview of Hardware modifications supported by software SOMARIS/10 syngo CT VA30

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2) Software version SOMARIS/10 syngo CT VA30

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

Term	Definition
N/A	The feature is not supported for the subject device
New	The feature is newly supported for Siemens CT Scanners and the subject device
Modified	This feature is modified from the previously cleared version
Unmodified	This feature remains unchanged from the predicate device
Enabled	This feature is currently supported by other cleared Siemens CT systems. This featurewill be supported for the subject device with software version SOMARIS/10 syngo CTVA30 and is unmodified from cleared version.

Table S01: Overview of Hardware Modifications supported by software SOMARIS/10 syngo CT VA30

	SOMATOM X.cite with SOMARIS/10 syngo CT VA30	Subject Device	Subject Device
#	hardware properties	SOMATOM X.cite	Scan&GO
1	Patient Observation Camera	Modified	N/A
2	Moodlight	Modified	N/A
3	Various Tablet Configuration	Modified	Modified
4	High Power 70 / High Power 80	Enabled	N/A
5	Adaptive Dose Shield	Enabled	N/A
6	Tin Filter	Enabled	N/A
7	Split Filter	Modified	N/A
8	3D Camera	Enabled	N/A
9	Other hardware modifications(e.g. new bore size, enabled Vectron™ Tube)	Modified	N/A

Table S02: Overview Software modifications of SOMATOM X.cite with syngo CT VA30

	SOMATOM CT System Scanner with
	SOMARIS/10 syngo CT VA30	Subject Devices	Subject Device
#	Software properties	SOMATOM X.cite	Scan&GO
1	MPPS	Enabled	N/A
2	Flex Dose Profile	Modified	N/A
3	Flex 4D Spiral	Modified	N/A
4	DirectDensityTM	Enabled	N/A
5	Scan&GO - Mobile Workflow	Modified	Modified
6	CT View&GO - Advanced tools	Modified	N/A
7	Check&GO - Metal Detection	New	New
8	CARE Contrast III and Contrast media protocol	Modified	N/A
9	CARE kV	Modified	N/A
10	kV and Filter independent CaScore (Artificial120)	Enabled	N/A
11	Recon&GO - Advanced Reconstruction	Modified	N/A
12	Recon&GO - Post-Processing plug in functions	Modified	N/A
13	TwinBeam Dual Energy	Modified	N/A
14	TwinSpiral Dual Energy	Modified	N/A
15	FAST Planning, FAST Window	Modified	N/A
16	HD FoV 4.0	Enabled	N/A
17	Imaging - workflow decision tree	New	New
18	Imaging - Cardio BestPhase	Enabled	N/A
19	Multistudy	Modified	N/A
20	Multiphase	Modified	N/A
21	Respiratory Motion Management	Enabled	N/A
22	Patient Marking - Direct Laser Steering	New	New
23	Automatic Patient Instruction	Modified	N/A
24	FAST Integrated Workflow (including FAST 3D Camera)	Modified	N/A
25	ADMIRE	Enabled	N/A

A comparison of these modifications with respect to the predicate devices is provided in the "Comparison of Technological Characteristics with the Predicate Device" section below.

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V. Indications for Use

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

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

Scan&GO:

VI. Comparison of Technological Characteristics with the Predicate Device

The SOMATOM X.cite scanner provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software components of these scanners have been modified or improved in comparison to the predicate devices to support enhanced device functionality.

The hardware components of the subject devices have been modified to support mobile workflow with multiple tablet configuration, a 3D Camera workflow for patient positioning, a larger bore size, modified gantry mechanics, tube and patient tables and Vectron x-ray tube.

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

The intended use and fundamental scientific technology for the SOMATOM X.cite remains unchanged from the predicate devices.

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

Scanner Principle- Whole body X-Ray Computed Tomography Scanner ●
System Acquisition Continuously rotating tube detector system ●
Iterative Reconstruction Support of various iterative reconstruction methods ●
Workplaces Support of workplaces that include reconstruction and image evaluation software .
Patient table
Patient table foot switch for movement ●
Tin filtration technology
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 Intervention Workflow Guide&GO ●
Optional Injector Arm

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Long scan range
DirectDensity™ Reconstruction, which provides CT images with an HU-like scaling that is nearly . proportional to relative electron density or relative mass density
. Respiratory Scan - Functions

The following technological differences exist between the subject device SOMATOM X.cite and the primary predicate device SOMATOM go.Top (K173632) and the predicate device SOMATOM Force (K190578):

Software version SOMARIS/10 syngo CT VA30
Support of additional cybersecurity features ●
Multiple tablet configuration for enhanced mobile workflow and control functionality ●
. Additional options for Inline and GO technologies
. CT protocol workflow enhanced functionality for advanced examination including parameter for scan protocol and contrast media.
. Interface to RTP Lasers for direct laser steering (e.g. in combination with 3rd party LAP laser system)
CT gantry hardware supporting large bore size and 50 cm scan field-of-view ●

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

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

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

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

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	Device Comparison
Hardware Property	Subject DeviceSOMATOM X.cite	Primary Predicate DevicesSOMATOM go.Top(K173632)	Predicate DeviceSOMATOM Force(K190578)
Scanner	whole body X-ray computed tomography scanner	whole body X-ray computed tomography scanner	whole body X-ray computed tomography scanner
Generatormax. power	105 kW	75 kW	2x 120 kW
Detectortechnologie	Stellar	Stellar	Stellar
Detectorvolumen coverage	38.4 mm	38.4 mm	2 x 57,6 mm
Detectorphysical rows	64	64	2 x 96
Detectorslice width	0.6 mm	0.6 mm	0.6 mm
DetectorDAS channel No.	840	840	736920
Detectorimage slices	128	128	2 x 192
TubeTechnologie	Vectron	Athlon	Vectron
TubekV steps	(in 10kV steps)70 kV to 150kV	(in 10kV steps)70 kV to 140kV	(in 10kV steps)70 kV to 150kV
Tubemax. current	1200 mA	825 mA	2 x 1300 mA
Tubetube focus	0.6 x 0.70.8 x 1.1	1.0 x 1.20.8 x 0.8	0.4 x 0.5/0.6 x 0.7/0.8 × 1.1(for both tubes)
Tubeheat capacity	higher than 30 MHU	6 MHU	higher than 30 MHU
Gantrybore size	82 cm	70 cm	78 cm
GantryFoV	50 cm	50 cm	50 cm
Gantryrotation time (sec)	0.3, 0.5, 1.0	0.33, 0.5, 1.0	0.25, 0.285,0.33, 0.5,1.0
GantryTilt [degree]	+/-25	+/-30	N/A
Patient Tabletype	Vario RT: 1.600 m,Vario 2: 2.000 m	Vario 1 and Vario RT:1.600 mm, Vario 2: 2.000 mm	PHS5, MPT4:1.600 m or 2.000 m
Max. Scan lengthTopogram	1680 mm 2080 mm	1600 mm, 2000 mm	1600 mm, 2000 mm
Max. Scan lengthImage acquisition	1600 mm, 2000 mm	1600 mm, 2000 mm	1600 mm, 2000 mm
Spectral filtrationOption*	Combined Split Filter / Tin Filtersupported, plus extra Tin Filter	Combined Split Filter / Tin Filtersupported	Tin Filter for both tubes
3D Camerafor patient positioning	option for patient positioningwith 3D Camera	N/A	option for patient positioningwith 3D Camera
High Power 70	1200 mA(@ 70 kV)	825 mA(@ 70 kV)	1300 mA(@ 70 kV)
High Power 80	1200 mA(@ 80 kV)	825 mA(@ 80 kV)	1300 mA(@ 80 kV)

Table S03: SOMATOM X.cite comparable hardware properties

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

Table S04: SOMATOM X.cite comparable software properties

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Propertiessoftware	Subject DeviceSOMATOM X.cite(syngo CT VA30)	Primary Predicate DeviceSOMATOM go.Top(K173632)	Predicate DeviceSOMATOM Force(K190578)
OperatingSystem	Windows basedSOMARIS/10 syngo CT VA30	Windows basedSOMARIS/10 syngo CT VA20A	Windows basedSOMARIS/7 syngo CT VB20
	syngo Acquisition Workplace(AWP)	syngo Acquisition Workplace(AWP)	syngo Acquisition Workplace(AWP)
AcquisitionWorkplace	syngo Viewing, syngo Filmingand syngo Archiving &Networking	syngo Viewing, syngo Filmingand syngo Archiving &Networking	syngo Viewing, syngo Filmingand syngo Archiving &Networking
	Image Reconstruction	Image Reconstruction	Image Reconstruction
Stellar Detector	Stellar detector firmwaresupported	Stellar detector firmwaresupported	Stellar detector firmwaresupported
Teamplay	Support teamplay Protocols	Support teamplay Protocols	Support teamplay Protocols
Protocols(Single SourceCT ScannerSystem)	Support of :Protocols for Radiation Therapy Planning support patient marking Protocols that allow scanning with support of an external respiratory gating system (ANZAI, Varian RGSC) Protocol supporting contrast bolus-triggered data acquisition Contrast media protocols Pediatric Protocols Flex Dose Profile TwinBeam DE TwinSpiral DE Flex 4D Spiral	Support of :Protocols for Radiation Therapy Planning Protocol supporting contrast bolus-triggered data acquisition Pediatric Protocols	Support of :Protocols for Radiation Therapy Planning Protocols that allow triggering of breath hold scanning from external device. Protocol supporting contrast bolus-triggered data acquisition Pediatric Protocols Adaptive Dose Area DualSource DE Adaptive 4D Spiral
post-processingmethods(syngo CT VA30enable a subsetof methods onthe scannersoftwareinstallation –only applicablefor previouslycleared syngoapplications)	enabled via software interfaceRecon&GO - Inline Resultsvaries methods contained in theavailable applicationssyngo.CT Coronary Analysissyngo.CT Vascular Analysissyngo.CT Dual Energysyngo.CT Bone ReadingNote 1: Detailed informationabout the subset of enabledsyngo.CT functionalities are listedbelow.	enabled via software interfaceRecon&GO - Inline Resultsvaries methods contained in theavailable applicationssyngo.CT Vascular Analysissyngo.CT Bone Readingsyngo.CT MM Oncologysyngo.CT Dual Energysyngo.via (incl. MM ReadingALPHA technology)syngo.CT Clinical Extensionssyngo.CT LungCADsyngo.via RT Image Suite	enabled via stand alone workplacesoftware installationvaries methods contained in theavailable applicationsThe user will operate the SOM/7-based scannerworkplace and in addition havethe possibility to use post-processing applications providedby a syngo.via-based system onthe acquisition workplace.
Cybersecurity	IT Hardening	IT Hardening	IT Hardening
HD FoV	HD FoV 4.0	HD FoV 3.0	HD FoV 4.0
Standardtechnologies	FAST Features CARE Features GO technology	FAST Features CARE Features GO technology	FAST Features CARE Features
FAST IntegratedWorkflow forpatientpositioning	FAST Integrated Workflow steps supported: FAST Isocentering FAST Range FAST Direction FAST Topo FAST Planning FAST 3D Align	N/A	FAST Integrated Workflow steps supported: FAST Isocentering FAST Range FAST Direction FAST Topo FAST Planning FAST 3D Align
Propertiessoftware	Subject Device	Primary Predicate Device	Predicate Device
	SOMATOM X.cite	SOMATOM go.Top	SOMATOM Force
	(syngo CT VA30)	(K173632)	(K190578)
DirectDensityTM	DirectDensityTM(including relative electrondensity and relative mass density)	N/A	DirectDensityTM(including relative electrondensity and relative mass density)
breath-holdtechnique	Respiratory Motion Managementsupport breath hold triggeredspiral scans with manual breathhold triggered examinations.	Respiratory Motion Managementsupport breath hold triggeredspiral scans with manual breathhold triggered examinations.	Respiratory Motion Managementsupport breath hold triggeredspiral scans with manual breathhold triggered examinations andDirectBreathhold™ (automatedtrigger supported)
Respiratorygating scanmodes	Respiratory gated spiral andrespiratory triggered sequencescan modes	Respiratory gated spiral scanmode	Respiratory gated spiral scanmode
IterativeReconstructionMethods	• ADMIRE• iMAR	• SAFIRE• iMAR	• ADMIRE• SAFIRE• iMAR

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Note 1: Detail information to support Recon&GO

The summary below provides detailed information about the subset of functionalities enabled by Recon&GO -Advanced Reconstruction.

Additional advanced reconstruction tools are provided through the advanced functionality of Recon&&GO:

Spectral Recon (Dual Energy Reconstruction)
Inline Results DE SPP (Spectral Post-Processing)
Inline Results DE Ranges (Parallel/Radial) / Inline DE

Table S05: Overview of Recon&GO advanced reconstruction tools supported by SOMATOM X.cite

Recon&GO - Advanced Reconstruction	510(k) information of the medical devicesoftware application that supportsame reconstruction tools
Recon&GO / Spectral Recon support image types- Virtual Unenhanced- Monoenergetic Plus	Reference Device K191468 -syngo.CT Dual Energy
Recon&GO / Inline Results DE SPP support- Dual Energy Spectral Post-Processing	Reference Device K191468 -syngo.CT Dual Energy
Recon&GO - Inline Results DE Ranges support the applicationclasses:- Bone Removal/Direct Angio- Liver VNC- Monoenergetic +- Virtual Unenhanced- Lung Analysis- Gout- Kidney Stones*)- Bone Marrow- Brain Hemorrhage- Rho/Z- Liver Fat Map	Reference Device K191468 -syngo.CT Dual Energy
*) Kidney Stones is designed to support the visualization of thechemical composition of kidney stones and especially thedifferentiation between uric acid and non-uric acid stones. Forfull identification of the kidney stone additional clinicalinformation should be considered such as patient history andurine testing. Only a well-trained radiologist can make the finaldiagnosis under consideration of all available information. Theaccuracy of identification is decreased in obese patients.

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Recon&GO - Advanced Reconstruction	510(k) information of the medical devicesoftware application that supportsame reconstruction tools

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

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

Enabled Recon&GO - Post-Processing plug infunctions	510(k) information of the medical device softwareapplication that support same established post-processing methods
Heart Isolation, Coronary Tree,Vessel Ranges (LAD, RCA, CX), Cardiac Ranges	Reference Device K173637 - syngo.CT CoronaryAnalysis
Vascular ranges (Aorta, Carotis L Int., Carotic R Int.,Runoff L, Runoff R)Inline Table removal, Inline Bone removal	Reference Device K173637 - syngo.CT VascularAnalysis
Radial Rib Ranges, Parallel Rib Ranges and SpineRange	Reference Device K123584 - syngo.CT BoneReading

Any differences in technological characteristics do not raise different questions of safety and effectiveness. Siemens believes that the subject device is substantially equivalent to the predicate devices. Testing and validation is completed. Test results show that the subject device SOMATOM X.cite, is comparable to the predicate devices SOMATOM go.Top (K173632) and SOMATOM Force (K190578) 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 SOMATOM X.cite during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

The general purpose of each tests is to verify and validate the functionality of the subject device modifications.

Testing will cover all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:

System Test (ST):

Acceptance test (workflow and user manual test) ●
Legal and Regulatory test .
System Integration Test (SIT):
- System Integration Test (functional) ●
- Image Quality (IQ) test ●
- DICOM tests

Subsystem Integration Test (SSIT):

Subsystem Integration Test ●
. DICOM tests

Tests are conducted for all software components developed in product development and for the complete product itself. Several activities are taken into account for this process, including creation of test specifications that relate to software requirements including tests to address risk mitigations that are identified, documented and traced by hazard keys.

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

Table S07: Non-Clinical Performance Testing

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#	Feature/Non-Clinical Supportive Testing	Document Title	Testing Performed
01	kV and Filter independent CaScore	Evaluation of DirectDensity and Artificial120 kernels on Somaris/10 VA30	The test results show that performance of special kernel variants Artifical120 and eDDensity and mDDensity is similar or improved within the limits of accuracy of the test com-pared to the respective initial release versions. In conclusion, the features DirectDensity and Calcium Scoring at any kV have been enabled for the release SOMARIS/10 VA30.
02	Recon&GO - Spectral Recon	Detailed Description and Bench Test for the Feature "Spectral Recon"	Deviations between the already cleared image processing algorithms in Inline DE and the new technical realization "Spectral Recon" are extremely small and are not expected to have any impact on the diagnostic performance. Residual deviations are a consequence of rounding differences and slight differences in implementation.
03	TwinSpiral Dual Energy / TwinSpiral DE	Detailed Description and Bench Testfor the Feature "TwinSpiral"	Based on these results it can be stated that the TwinSpiral Dual Energy CT scan mode provides CT-images of diagnostic quality, which are similar to conventional 120kV images in terms of CT-values and image noise at same radiation dose. The mixed images show a slight reduction in the iodine CT-value, but at the same time image noise at same dose is also lower. So in combination the iodine CNR at same radiation dose is comparable between Mixed images and 120kV images.
04	Flex 4D Spiral - Neuro/Body	Flex4D Spiral: Technical principals and demonstration of freely selectable scan ranges (Somaris/10 VA30)	Scan ranges with the new Flex4D Spiral feature can be freely selected within the limits mandated by the scan mode and protocol. The scanned volume was found to be in agreement with the planned scan range for a variety of different tested scan modes, scan lengths and scanners.Radiochromic film placed in the isocenter for a variety of scan ranges showed that the irradiated range markers displayed by the scanner acquisition software during the planning of the respective F4DS scans were in good agreement with the exposed area on the film.
05	DirectDensity	Evaluation of DirectDensity and Artificial120 kernels on Somaris/10 VA30	Evaluation of phantom images to demonstrate the subject device features ability to provide images that can be shown as relative mass density or relative electron density. The conducted test performed demonstrated the subject device's ability to show relative mass or relative electron density images.
06	HD FoV	HDFoV 4.0: Technical principles and phantom measurements evaluating HU accuracy and skin-line accuracy in the extended field of view (FoV) region (Som/10 VA30)	Phantom testing conducted to assess the subject device ability to provide visualization of anatomies outside the standard field of view and that the image quality standards for radiotherapy applications are met.
07	Contrast media protocol	Siemens Healthineers factory contrast protocols and comparison to approved drug labeling	Selected Factory Contrast Protocols are within the limits as prescribed by the approved labeling of Ultravist®". (No Ultravist protocol for coronary CTA)
#	Feature/Non-Clinical SupportiveTesting	Document Title	Testing Performed
08	InjectorCoupling	Siemens HealthineersInjection Parameter ExchangeValidation	Correctness of the contrast injection parameterstransferred between the CT device and thesupported injection devices has been verified.
09	FAST IntegratedWorkflow	FAST 3D Camera Evaluation	FAST Isocentering: Clinical data based softwarevalidation to assess accuracy of patient isocenterproposal for feature Conducted test for the subjectdevice FAST Isocentering demonstrated that therewas a lower isocenter deviation for the subjectdevice in comparison to the predicate device.FAST Range: Based on manually triggerd cameraimages comparison and measurement of deviationof manual annotation of patient landmark andbased on video stream images supporting thefeature proposed patient landmark Conducted testdemonstrated that a lower deviation for landmarkboundaries for the subject device in comparison tothe predicate device.

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

Table S08: Recognized Consensus Standards
Date ofRecognition	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
06/27/2016	12-300	NEMA	PS 3.1 - 3.20 (2016)	Digital Imaging AndCommunications In Medicine(DICOM) Set
03/14/2011	12-225	NEMA	XR-25	Computed Tomography Dose Check
01/27/2015	12-287	NEMA	XR-28 2013	Supplemental Requirements ForUser Information And SystemFunction Related To Dose In CT
6/27/2016	5-40	ANSI AAMIISO	14971:2007/(R)2010(Corrected 4 October2007)	Medical Devices - Applications OfRisk Management To MedicalDevices
		ISO	14971 Second Edition2007-03-01	Medical Devices - Applications OfRisk Management To MedicalDevices
01/14/2019	13-79	IEC	62304 Edition 1.1 2015-06 CONSOLIDATEDVERSION	Medical Device Software - SoftwareLife Cycle Processes
07/09/2014	19-4	ANSI AAMI	ES60601-1:2005/(R)2012 AndA1:2012,	C1:2009/(R)2012 AndA2:2010/(R)2012 (ConsolidatedText) Medical Electrical Equipment- Part 1: General Requirements ForBasic Safety And EssentialPerformance (IEC 60601-1:2005,MOD)
09/17/2018	19-8	ANSI AAMIIEC	60601-1-2:2014	Medical Electrical Equipment -- Part1-2: General Requirements ForBasic Safety And EssentialPerformance -- Collateral Standard:Electromagnetic Disturbances --Requirements And Tests
7212/23/2016	5-114	ANSI AAMIIEC	62366-1:2015	Medical Devices - Part 1:Application Of UsabilityEngineering To Medical Devices

Traditional 510(k) for SOMATOM X.cite with software version SOMARIS/10 syngo CT VA30

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Table S08: Recognized Consensus Standards
Date ofRecognition	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
07/09/2014	12-273	IEC	60825-1 Edition 2.02007-03	Safety Of Laser Products - Part 1:Equipment Classification, AndRequirements [Including: TechnicalCorrigendum 1 (2008),Interpretation Sheet 1 (2007),Interpretation Sheet 2 (2007)]
06/27/2016	12-302	IEC	60601-2-44 Edition 3.2:2016	Medical Electrical Equipment - Part2-44: Particular Requirements ForThe Basic Safety And EssentialPerformance Of X-Ray EquipmentFor Computed Tomography
01/14/2014	12-269	IEC	60601-1-3 Edition 2.12013-04	Medical Electrical Equipment - Part1-3: General Requirements ForBasic Safety And EssentialPerformance - Collateral Standard:Radiation Protection In DiagnosticX-Ray Equipment
06/27/2016	5-89	IEC	60601-1-6 Edition 3.12013-10	Medical Electrical Equipment - Part1-6: General Requirements ForBasic Safety And EssentialPerformance - Collateral Standard:Usability
03/14/2011	12-226	IEC	61223-2-6 SecondEdition 2006-11	Evaluation And Routine Testing InMedical Imaging Departments - Part2-6: Constancy Tests - ImagingPerformance Of ComputedTomography X-Ray Equipment
01/30/2014	12-270	IEC	61223-3-5 First Edition2004-08	Evaluation And Routine Testing InMedical Imaging Departments - Part3-5: Acceptance Tests - ImagingPerformance Of ComputedTomography X-Ray Equipment[Including: Technical Corrigendum1 (2006)]
06/07/2018	12-309	IEC	60601-2-28 Edition 3.02017-06	Medical Electrical Equipment - Part2-28: Particular Requirements ForThe Basic Safety And EssentialPerformance Of X-Ray TubeAssemblies For Medical Diagnosis
06/27/2016	12-299	IEC	62563-1 Edition 1.1	Medical Electrical Equipment -Medical Image Display Systems -Part 1: Evaluation Methods

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

Traditional 510(k) for SOMATOM X.cite with software version SOMARIS/10 syngo CT VA30

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Table S09: General Use Consensus Standards
StandardDevelopingOrganization	StandardDesignationNumber andDate	Title of Standard	How was Standard Used
		conformity – Part 2:Supporting documentation.

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

Table S10	FDA Guidance Document and Effective Date
1.	Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket Notification Submissions510(k)Document issued on October 2, 2017
2.	Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)sDocument issued on February 21, 2019
3.	Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s - Guidance for Industry and FDA StaffDocument issued on August 12, 2005
4.	Guidance for Industry and FDA Staff: Deciding when to submit a 510(k) for a change to an existing device.Document issued on October 25, 2017
5.	Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating 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 DevicesDocument issued on May 11, 2005
7.	Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in Medical DevicesDocument issued on September 9, 1999
8.	Guidance for Industry and FDA Staff: Applying Human Factors and 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 DevicesDocument issued on July 11, 2016
12.	Guidance for Industry and Food Drug Administration Staff: Design considerations and Pre-Market Submission recommendations for Interoperable Medical devicesDocument Issued on September 6, 2017
13.	Guidance for Industry and Food Drug Administration Staff:Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical DevicesDocument issued on September 14, 2018

Verification and Validation

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

Siemens conforms to the Cybersecurity requirementing 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.

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

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

Wireless Coexistence Testing

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

Testing for co-existence considered for following scenarios:

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

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

Customer Use Testing

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

Internal Clinical Use Test: The CT scanner customer environment is simulated in Siemens Test Cabins. For such a test, customers with clinical expertise are typically invited to perform tests.
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. Multiple tablet for visualization purpose, using same Scan&GO installation and feature configuration does not change the intended use.

Additional Supportive Data

The National Lung Screening Trial (NLST), sponsored by the National Cancer Institute, is used to support the additional lung cancer screening Indications for Use. The study was a randomized trial of screening with the use of low-dose CT compared to chest radiography to determine 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.

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 mitifed 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.

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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 device is also tested using the same methods as used for the predicate devices. The non-clinical data supports the safety of the device and software verification and validation demonstrates that the subject device SOMATOM X.cite should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM X.cite performs comparably to the predicate devices currently marketed for the same intended use. Since all predicate devices were tested using the same methods, Siemens believes that the data generated from the SOMATOM X.cite testing supports 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.