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 staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

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.

Device Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

SOMATOM go. Platform CT scanner systems:

. SOMATOM go.Up
. SOMATOM go.Now
SOMATOM go.All
SOMATOM go.Top
. SOMATOM go.Sim
. SOMATOM go.Open Pro

SOMATOM X. Platform CT scanner systems:

. SOMATOM X.cite
. SOMATOM X.ceed

In this submission, the above listed CT scanner systems are jointly referred to as subject devices by "SOMATOM go. Platform" and "SOMATOM X. Platform" CT scanner systems.

The subject devices SOMATOM go. Platform and SOMATOM X. Platform with SOMARIS/10 syngo CT VB10 are Computed Tomography X-ray Systems which feature one continuously rotating tubedetector system and function according to the fan beam principle (single source). The SOMATOM go. Platform and SOMATOM X. Platform with software SOMARIS/10 syngo CT VB10 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.

Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.

The platform software for the SOMATOM go. Platform and SOMATOM X. Platform, SOMARIS/10 synqo CT VB10, is a command-based program used for patient management, data management, Xray scan control, image reconstruction, and image archive/evaluation.

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

New software version syngo CT VB10 (SOMARIS/10 syngo CT VB10) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the predicate device in K211373.

Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as an optional upgrade for the applicable existing SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems.

The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. The supporting data are similar, primarily one review division/group will be involved, and the indications for use is the same between the devices. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.

AI/ML Overview

The provided text is a 510(k) summary for a Computed Tomography (CT) system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical testing and comparison of technological characteristics. The document does not contain information about comparative effectiveness studies, multi-reader multi-case (MRMC) studies, or detailed clinical study results with ground truth establishment as one might find for a novel AI/ML-driven diagnostic device.

Therefore, many of the requested items (e.g., sample size for the test set, number of experts, adjudication methods, MRMC study effect size, training set details) are not explicitly mentioned in this type of submission. The focus here is on the CT system itself and its software updates, not on a new AI algorithm for detection or diagnosis where such detailed performance metrics against ground truth would be paramount.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria & Reported Device Performance

The document describes "bench testing" as non-clinical supportive testing for specific features. The acceptance criteria are generally qualitative (e.g., "comparable accuracy," "reduce the number of alignment artefacts," "successfully detect needle-tips") rather than specific numerical thresholds.

Feature / Non-clinical Supportive Testing	Acceptance Criteria (Implicit from Objectives)	Reported Device Performance (Test Results)
FAST 3D Camera / FAST Integrated Workflow	Accuracy of FAST Isocentering, FAST Range, and FAST Direction comparable to predicate device (syngo CT VA40) with old camera hardware and ceiling mount.	FAST Isocentering: Comparable accuracy to predicate, regardless of camera mounting. FAST Range: Detection accuracy of body region boundaries comparable. (Note: Legs can be occluded by torso in gantry mounting, not severe limitation as leg exams are usually feet-first). FAST Direction: Pose detection results comparable accuracy. Overall: SOMARIS/10 syngo CT VB10 delivers comparable accuracy to predicate for new FAST 3D Camera hardware, also in new gantry position.
Multi-Purpose Table	Sufficient freedom of movement for a mobile C-arm X-ray system for clinical routine without significant limitations for myNeedle Lasers or FAST 3D Camera when installed with enhanced distance (674 mm) to CT gantry and offering iCT mode functionality.	Technical feasibility and possible limitations evaluated. Concluded that the CT scanner with a Multi-Purpose (Vitus) Patient Table, enhanced distance (674 mm) and iCT mode, provides sufficient freedom of movement for a mobile C-arm X-ray system to be used for clinical routine without any significant limitations.
Direct Breathhold	A spiral scan can be automatically triggered from an external respiratory gating device, with the actual scan remaining unchanged and the object correctly depicted.	Test results showed a spiral scan can be automatically triggered, actual scan remains unchanged, and object is correctly depicted.
ZeeFree	Reduce number of artifacts attributed to stack misalignment; no new artifacts introduced; equivalent image quality in quantitative standard physics phantom-based measurements (noise, homogeneity, high-contrast resolution, slice thickness, CNR); equivalent image quality in quantitative and qualitative phantom-based measurements for metal objects; algorithm successfully applied to phantom data demonstrating correct technical function; algorithm independent from physical detector width.	If misalignment artifacts identified, "Cardiac Stack Artefact Correction" (ZeeFree) enables optional stack artifact corrected images which reduce number of alignment artifacts. Does not introduce new artifacts. Realizes equivalent image quality in quantitative standard physics phantom-based measurements (ACR, Gammex phantom) in terms of noise, homogeneity, high-contrast resolution, slice thickness and CNR. Realizes equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects. Successfully applied to phantom data from a motion phantom. Independent from physical detector width.
myNeedle Guide (with myNeedle Detection)	Clinical usability of the needle detection algorithm, accuracy of automatic needle detection, reduction of necessary user interactions for navigating to a needle-oriented view.	Algorithm consistently detected needle-tips in 90.76% of cases over a wide variety of scans. Auto needle detection functionality reduces the number of interaction steps needed to generate a needle-aligned view. With successful AI-based needle tip detection, no user interaction is needed to achieve needle-aligned view during needle progression (manual adjustment always possible).

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not explicitly stated for any of the individual feature tests. The tests refer to "phantom tests" and "analysis of phantom images". For "myNeedle Guide," it mentions "a wide variety of scans," but no specific number.
Data Provenance: The document does not specify the country of origin for the test data (phantoms) or if any retrospective/prospective human data was used. Given the nature of these tests (bench testing on phantoms), human patient data is generally not the primary focus for these types of technical evaluations.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as the testing primarily involves technical and phantom-based evaluations, not clinical reader studies requiring expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable/provided as detailed clinical studies with reader adjudication are not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC comparative effectiveness study is not mentioned in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through technical testing and feature comparison, not on quantifying improvement in human reader performance with or without AI assistance.

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

For the "myNeedle Guide" feature, the 90.76% detection rate of needle tips might be considered a form of standalone performance for that specific algorithmic component, though it's still being evaluated in the context of aiding a human user. For other features, the tests are primarily system-level or component-level functional checks.

7. The Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" would be established through phantom specifications and controlled experimental setups with known parameters (e.g., precise needle location in a phantom, known artifact presence/absence in a reconstructed image). This is typical for engineering verification and validation testing for CT systems.
For the "myNeedle Guide," the "ground truth" for needle tip detection would likely be based on the known, true location of the needle tip within the phantom or experimental setup.

8. The Sample Size for the Training Set

This information is not provided. The document describes software updates and system features, not the development of a new AI model from a training set. If the "myNeedle Guide" used machine learning, its training set details are not described here.

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

This information is not provided as no training sets are explicitly described.

Summary

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

March 26, 2024

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

Re: K233650

Trade/Device Name: SOMATOM go.Up: SOMATOM go.Now: SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 23, 2024 Received: February 23, 2024

Dear Clayton Ginn:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K233650
Device Name
SOMATOM go.Up;
SOMATOM go.Now;
SOMATOM go.All;
SOMATOM go.Top;
SOMATOM go.Sim;
SOMATOM go.Open Pro;
SOMATOM X.cite;
SOMATOM X.ceed
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 staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots in a pattern.

510(k) Summary for K233650

SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems

with software version SOMARIS/10 syngo CT VB10

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. Contact Details

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 -OR- Rittigfeld 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

Note: Descriptions in this submission use the short company name Siemens. It covers both manufacturing locations and names as listed above. Brand name on all products is Siemens Healthineers.

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Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

Submitter Contact Person:

Clayton Ginn Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 898-2692 clayton.ginn@siemens-healthineers.com Backup Contact: Kenny Bello Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: (205) 856-6099 monsuru.bello@siemens-healthineers.com

II. Device Name and Classification

Table 1: Subject Device Names

Product Name	Trade Name
SOMATOM go.Up	SOMATOM go.Up
SOMATOM go.Now	SOMATOM go.Now
SOMATOM go.All	SOMATOM go.All
SOMATOM go.Top	SOMATOM go.Top
SOMATOM go.Sim	SOMATOM go.Sim
SOMATOM go.Open Pro	SOMATOM go.Open Pro
SOMATOM X.cite	SOMATOM X.cite
SOMATOM X.ceed	SOMATOM X.ceed
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 Name:	SOMATOM CT Scanner Systems with SOMARIS/10 syngo CT VA40software
510(k) Number:	K211373
Clearance Date:	August 27, 2021
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 devicedesign.

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Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots arranged in a pattern.

Reference device:
Trade Name:	SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB30software
510(k) Number:	K230421
Clearance Date:	June 16, 2023
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 devicedesign.

Note:

K211373 was a bundle submission with various Siemens CT Scanner Systems, including the CT scanner systems 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.

K230421 was a bundle submission with various Siemens CT Scanner Systems, including the dual source CT scanner systems SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash and the single source CT scanner CT systems SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open.

IV. Device Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

SOMATOM go. Platform CT scanner systems:

. SOMATOM go.Up
. SOMATOM go.Now
SOMATOM go.All
SOMATOM go.Top
. SOMATOM go.Sim
. SOMATOM go.Open Pro

SOMATOM X. Platform CT scanner systems:

. SOMATOM X.cite
. SOMATOM X.ceed

In this submission, the above listed CT scanner systems are jointly referred to as subject devices by "SOMATOM go. Platform" and "SOMATOM X. Platform" CT scanner systems.

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Image /page/6/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots of varying sizes.

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.

New software version syngo CT VB10 (SOMARIS/10 syngo CT VB10) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the predicate device in K211373.

Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as an optional upgrade for the applicable existing SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems.

V. Indications for Use

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

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

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.

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Image /page/7/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" are several orange dots arranged in a circular pattern.

VI. Indications for Use Comparison

Subject Device 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 staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

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

Primary Predicate Device 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.

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

Comparison:

The subject device Indications for Use is the exact same as the reference predicate's Indications for Use (K230421), however it is slightly different than the primary predicate's Indications for Use.

1. The sentence "The images delivered by the system can be used by a trained physician as an aid in diagnosis" was removed, since the subsequent sentence restates the same, replacing 'trained physician' with 'trained staff'. It can be assumed a trained physician is part of the trained staff.
  To consider that in the US, the standard of care is for physicians to perform diagnosis/treatment, Siemens added the following statement in the Device Description above and an equivalent warning exists in the labeling:

"Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system."

1. The word 'preparation' has been removed from the phrase "treatment preparation and radiation therapy planning" since treatment planning better describes how the device is used.

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Image /page/8/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

1. The phrase "as well as for diagnostic and therapeutic interventions" was added to the second sentence. This was done to express use of the device in standard practice. This device can and is commonly used as an aid in invasive procedures.
  None of the intended use includes computed tomography as the principal means of guidance in invasive procedures (involving the introduction of a device, such as a needle or a catheter into the body of the patient).

The subject devices SOMATOM go. Platform and SOMATOM X. Platform are not the principal means of guidance, because the CT Systems do not guide the invasive procedures, the needle orientation and the needle advance and handling is always done under the physicians control.

VII. Comparison of Technological Characteristics with the Predicate Device

Supported by the subject device, SOMARIS/10 syngo CT VB10 software version is a further development of the SOMARIS/10 syngo CT VA40 software version which is cleared in K211373.

The SOMATOM go. Platform and the SOMATOM X. Platform with SOMARIS/10 syngo CT VB10 software version provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software features of SOMATOM go. Platform and SOMATOM X. Platform have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices.

The new syngo CT VB10 software reuses all unmodified software features of the legacy software syngo CT VA40 cleared in K211373. Additionally, no features present in the predicate device are descoped.

Software version SOMARIS/10 syngo CT VB10 is designed to reuse hardware independent extended functionalities and GO technologies provided by Siemens cleared software applications.

The intended use and fundamental scientific technology for the SOMATOM go. Platform and SOMATOM X. Platform remain unchanged from the predicate devices.

At a high level, the subject and predicate devices are based on the same subset of 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 principles
Workplaces Support of workplaces that include reconstruction and image evaluation ● software
Patient table
Patient table foot switch for movement
Stellar Detector technology
. Tin filtration technology
. Vectron/Athlon/Chronon X-ray Tube depending on the CT system
Power Generator
Scan&GO
Mobile workflow (Tablet)
Optional injector arm

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Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots that are arranged in a circular pattern.

Optional support of CT guided intervention workflow (myNeedle Guide) ●
. Optional support of FAST 3D Camera operation for fast patient positioning workflow
. Scanner display and control functionality
Remote Scan Control
. Respiratory Gating Devices
. Standard CARE technologies
Standard FAST technologies
Standard GO technologies
. Precision matrix (large image matrices)
HD FoV
DirectDensity™ ●

Compared to the primary predicate device referenced in this submission, the subject devices SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems with SOMARIS/10 syngo CT VB10 support the modifications provided in the Table 3 under subsection 1) Modified Hardware and Table 4 under subsection 2) Modified Software.

The configuration table and comparison table use the following terms in Table 2 to describe various technological characteristics in comparison to the primary and secondary predicate devices 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 newly introducedwithin the subject device submission
Unmodified	The feature remains unchanged from that within the predicate device. Therelevant modification was already present within the predicate device.
Modified	This feature is modified from the predicate / reference devices
Enabled	This feature is currently supported by other cleared Siemens CT systems orcleared Siemens stand-alone software applications. This feature will besupported for the subject device with software version SOMARIS/10 syngo CTVB10 and is substantially equivalent compared to the cleared version of theprimary/reference predicate device.

Table 2: Overview of term definition.

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Image /page/10/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots.

1) Modified Hardware

Table 3: Overview of hardware modifications of SOMATOM go. Platform and SOMATOM X. Platform CT scanner systems with SOMARIS/10 syngo CT VB10.

#	Hardwareproperty	Subject deviceswith SOMARIS/10 syngo CT VB10
		SOMATOM go. Platform		SOMATOM X. Platform
		SOMATOM go.NowSOMATOM go.UpSOMATOM go.AllSOMATOM go.Top	SOMATOM go.SimSOMATOM go.Open Pro	SOMATOM X.citeSOMATOM X.ceed
1.	FAST 3D Camera	enabled	enabled	enabled
2.	CARE Breathe	enabled	N/A	unmodified
3.	CARE 2D Camera	enabled	unmodified	unmodified
4.	Moodlight	enabled	unmodified	unmodified
5.	CARE Moodlight	enabled	N/A	N/A
6.	Multi-PurposeTable (Vitus)	N/A	N/A	modified

2) Modified Software (syngo CT VB10)

Table 4: Overview of software modifications of SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems with SOMARIS/10 syngo CT VB10.

#	Software property	Subject deviceswith SOMARIS/10 syngo CT VB10
		SOMATOM go. Platform				SOMATOMX. Platform
		SOMATOMgo.Now	SOMATOMgo.Up	SOMATOMgo.AllSOMATOMgo.Top	SOMATOMgo.Sim	SOMATOMgo.Open Pro	SOMATOMX.citeSOMATOMX.ceed
1.	DirectBreathhold	N/A	enabled	enabled	enabled	enabled	enabled
2.	ZeeFree	N/A	N/A	enabled	enabled	enabled	enabled
3.	myNeedle Guide	enabled	enabled	enabled	enabled	enabled	enabled
4.	FAST IntegratedWorkflow	enabled	enabled	enabled	enabled	enabled	enabled
5.	Direct i4D	N/A	N/A	N/A	N/A	modified	modified
6.	myExamCompanion	enabled	modified	modified	modified	modified	modified
7.	myExam Satelite(Remote Recon)	enabled	enabled	enabled	enabled	enabled	enabled
8.	Recon&GO	modified	modified	modified	modified	modified	modified

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots that are arranged in a circular pattern.

#	Software property	Subject deviceswith SOMARIS/10 syngo CT VB10
		SOMATOM go. Platform					SOMATOMX. Platform
		SOMATOMgo.Now	SOMATOMgo.Up	SOMATOMgo.AllSOMATOMgo.Top	SOMATOMgo.Sim	SOMATOMgo.Open Pro	SOMATOMX.citeSOMATOMX.ceed
9.	CT View&GO	enabled	enabled	enabled	enabled	enabled	enabled
10.	Scan&GO	enabled	enabled	enabled	enabled	enabled	enabled
11.	Automatic Patientinstruction	enabled	enabled	enabled	enabled	enabled	enabled
12.	DirectSetup Notes	N/A	N/A	N/A	new	new	N/A
13.	ADMIRE	N/A	N/A	unmodified	enabled	enabled	unmodified

A tabular summary of the comparable hardware and software properties between the subject devices SOMATOM go. Platform and SOMATOM X. Platform with software version syngo CT VB10 and primary/reference predicate devices are listed in Table 9 below (modifications are in gray shaded sections).

Table 5: Comparison of technical hardware characteristics between subject devices SOMATOM go.Now and SOMATOM go.Up with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40.

Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMgo.Now	SOMATOMgo.Up	SOMATOMgo.Now	SOMATOMgo.Up
scanner	Whole body Computed Tomography(CT) Scanner System	Whole body Computed Tomography(CT) Scanner System	Whole body Computed Tomography(CT) Scanner System	Whole body Computed Tomography(CT) Scanner System
SystemConfiguration	Single Source		Single Source
Environment of Use	Professional Healthcare Facility		Professional Healthcare Facility
GeneratorMax. power (kW)	32		32
Detectortechnology	Stellarbased on UFC (Ultra Fast Ceramic)		Stellarbased on UFC (Ultra Fast Ceramic)
Detectorvolume coverage(mm)	11.2	22.4	11.2	22.4
Detector	16	32	16	32
Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMgo.Now	SOMATOMgo.Up	SOMATOMgo.Now	SOMATOMgo.Up
physical rows
DetectorSlice width (mm)	0.7		0.7
DetectorDAS channel no.	768		768
DetectorImage slices	32	64	32	64
Tubetechnology	Chronon		Chronon
TubekV steps	80, 110, 130		80, 110, 130
TubeMax. current (mA)	400		400
Tubefocus	• 0.8 x 0.4 / 8°• 0.8 x 0.7 / 8°		• 0.8 x 0.4 / 8°• 0.8 x 0.7 / 8°
TubeHeat storagecapacity (MHU)	3.5		3.5
TubeCooling rate (kHU/min)	915		915
GantryBore size	70		70
GantryScan FoV (cm)	50		50
GantryExtended FoV (cm)	70		70
GantryRot. time (sec)	0.5, 0.8, 1.0, 1.5		0.8, 1.0, 1.5
GantryTilt (degree)	N/A	+/- 30°-30° to +28° withoptional 307 kg	N/A	+/- 30°-30° to +28° withoptional 307 kg
Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMgo.Now	SOMATOMgo.Up	SOMATOMgo.Now	SOMATOMgo.Up
		patient table		patient table
Patient tableType	Vector (1250mm),Vario 1 (1600mm),Vario RT (1600mm)with tableextension	Vario 1 (1600mm),Vario 2 (2000mm),Vario RT (1600mm)with tableextension	Vector (1250mm),Vario 1 (1600mm),Vario RT (1600mm)with tableextension	Vario 1 (1600mm),Vario 2 (2000mm),Vario RT (1600mm)with tableextension
Patient tableMax. weightcapacity (kg)	Vector: 160Vario 1: 227Vario RT: 227	Vario 1: 227Vario 2: 307Vario RT: 227	Vector: 160Vario 1: 227Vario RT: 227	Vario 1: 227Vario 2: 307Vario RT: 227
Max. scan lengthtopogram	1680 mm withtable extension	1680 mm withtable extension2080 mm withtable extension	1680 mm withtable extension	1680 mm withtable extension2080 mm withtable extension
Max. scan lengthImage acquisition	Max. 1600 mmwith patienttable extension	Max. 1600 mmwith patienttable extensionMax. 2000 mmwith patienttable extension	Max. 1600 mmwith patienttable extension	Max. 1600 mmwith patienttable extensionMax. 2000 mmwith patienttable extension
Spectral filtration	Tin Filter		Tin Filter
High Power 80	yes	yes	yes	yes
FAST 3D Camera	option forpatientpositioning with3D Camera:• gantrymounted,modifieddesign	option forpatientpositioning with3D Camera:• ceilingmounted,modifieddesign• gantrymounted,modifieddesign	n.a.	option forpatientpositioning with3D Camera:• ceilingmounted
Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMgo.Now	SOMATOMgo.Up	SOMATOMgo.Now	SOMATOMgo.Up
x-ray foot switch	Option to trigger hands-freescanning	Option to trigger hands-freescanning	Option to trigger hands-freescanning	Option to trigger hands-freescanning
Table foot switch	Option for table patient movement	Option for table patient movement	Option for table patient movement	Option for table patient movement
i-joystick	Option for patient tablemovements, including an electricalconnection for the tablet dockwhich allows charging the tabletwhen mounted.	Option for patient tablemovements, including an electricalconnection for the tablet dockwhich allows charging the tabletwhen mounted.	Option for patient tablemovements, including an electricalconnection for the tablet dockwhich allows charging the tabletwhen mounted.	Option for patient tablemovements, including an electricalconnection for the tablet dockwhich allows charging the tabletwhen mounted.
Tablet dock	Option for mounting of the tableton the patient table.	Option for mounting of the tableton the patient table.	Option for mounting of the tableton the patient table.	Option for mounting of the tableton the patient table.
CARE Breathe	visualization of breathinginstructions to support threemessages in respiratory motionmanagement:• free breathing• preparation for breath hold• breath hold itself incombination with thevisualization of a countdownvisual patient instruction unit isplaced on the gantry front andgantry back in the gantry funnel		visual countdown indicator toprovide visual instruction inrespiratory motion management:• free breathing• preparation for hold breath• breath holdvisual countdown indicator is placedon the halo
CARE 2D camera	one integrated into the gantry frontand one mounted on the gantryback to monitor the patient duringexamination		2D camera* integrated on the haloplate*in syngo CT VA40 known as patientobservation camera
Moodlight	Illumination Moodlight to enhancepatient comfort supportedintegrated as a ring with LED lightinto the gantry front		Illumination Moodlight to enhancepatient comfort supportedIntegrated on the Halo
CARE Moodlight	LED lights integrated on the gantryfront cover indicating:• System startup		n.a.
Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMgo.Now	SOMATOMgo.Up	SOMATOMgo.Now	SOMATOMgo.Up
	• Scan countdown• Radiation on

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a curved line.

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots that are arranged in a pattern.

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots arranged in a circular pattern.

Table 6: Comparison of technical hardware characteristics between subject devices SOMATOM go.All and SOMATOM go.Top with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40.

Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10	SOMATOMgo.Top	Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)	SOMATOMgo. Top
	SOMATOMgo.All	SOMATOMgo.Top	SOMATOMgo.All	SOMATOMgo.Top
scanner	Whole body Computed Tomography(CT) Scanner System	Whole body Computed Tomography(CT) Scanner System	Whole body Computed Tomography(CT) Scanner System	Whole body Computed Tomography(CT) Scanner System
SystemConfiguration	Single Source	Single Source	Single Source	Single Source
Environment of Use	Professional Healthcare Facility	Professional Healthcare Facility	Professional Healthcare Facility	Professional Healthcare Facility
GeneratorMax. power (kW)	75	75	75	75
Detectortechnology	Stellarbased on UFC (Ultra Fast Ceramic)	Stellarbased on UFC (Ultra Fast Ceramic)	Stellarbased on UFC (Ultra Fast Ceramic)	Stellarbased on UFC (Ultra Fast Ceramic)
Detectorvolume coverage(mm)	22.4	38.4	22.4	38.4
Detectorphysical rows	32	64	32	64
DetectorSlice width (mm)	0.7	0.6	0.7	0.6
DetectorDAS channel no.	768	840	768	840
DetectorImage slices	64	128	64	128
Tube	Athlon	Athlon	Athlon	Athlon
Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMgo.All	SOMATOMgo.Top	SOMATOMgo.All	SOMATOMgo.Top
technology
TubekV steps	70 to 140 (in 10 kV steps)		70 to 140 (in 10 kV steps)
TubeMax. current (mA)	825		825
Tubefocus	• 1.1 x 1.2 / 8°• 0.8 x 0.8 / 8°		• 1.1 x 1.2 / 8°• 0.8 x 0.8 / 8°
TubeHeat storagecapacity (MHU)	7		7
TubeCooling rate (kHU/min)	Up to 1700		Up to 1700
GantryBore size	70		70
GantryScan FoV (cm)	50		50
GantryExtended FoV (cm)	70		70
GantryRot. time (sec)	0.33, 0.5, 1.0		0.33, 0.5, 1.0
GantryTilt (degree)	+/- 30°-30° to +28° with optional 307 kgpatient table		+/- 30°-30° to +28° with optional 307 kgpatient table
Patient tableType	Vario 1 (1600 mm)Vario 2 (2000 mm)Vario RT (1600 mm)with table extension		Vario 1 (1600 mm)Vario 2 (2000 mm)Vario RT (1600 mm)with table extension
Patient tableMax. weightcapacity (kg)	Vario 1: 227Vario 2: 307Vario RT: 227		Vario 1: 227Vario 2: 307Vario RT: 227
Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMgo.All	SOMATOMgo.Top	SOMATOMgo.All	SOMATOMgo.Top
Max. scan lengthtopogram	1680 mm with table extension2080 mm with table extension		1680 mm with table extension2080 mm with table extension
Max. scan lengthImage acquisition	Max. 1600 mm with patient tableextensionMax. 2000 mm with patient tableextension		Max. 1600 mm with patient tableextensionMax. 2000 mm with patient tableextension
Spectral filtration	Tin Filter	Combined TinFilter/Split filter	Tin Filter	Combined TinFilter/Split filter
High Power 70/High Power 80	825 (@70 kV)825 (@ 80 kV)		825 (@70 kV)825 (@ 80 kV)
FAST 3D Camera	option for patient positioning withFAST 3D Camera:• ceiling mounted, modified design• gantry mounted, modified design		option for patient positioning withFAST 3D Camera:• ceiling mounted
x-ray foot switch	Option to trigger hands-freescanning		Option to trigger hands-freescanning
Table foot switch	Option for table patient movement		Option for table patient movement
i-joystick	Option for patient tablemovements, including an electricalconnection for the tablet dockwhich allows charging the tabletwhen mounted.		Option for patient tablemovements, including an electricalconnection for the tablet dockwhich allows charging the tabletwhen mounted.
Tablet dock	Option for mounting of the tableton the patient table.		Option for mounting of the tableton the patient table.
CARE Breathe	visualization of breathinginstructions to support threemessages in respiratory motionmanagement:• free breathing• preparation for breath hold• breath hold itself incombination with thevisualization of a countdown		visual countdown indicator toprovide visual instruction inrespiratory motion management:• free breathing• preparation for hold breath• breath holdvisual countdown indicator is placedon the halo
Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMgo.All	SOMATOMgo.Top	SOMATOMgo.All	SOMATOMgo.Top
	visual patient instruction unit isplaced on the gantry front andgantry back in the gantry funnel
CARE 2D camera	one integrated into the gantry frontand one mounted on the gantryback to monitor the patient duringexamination		2D camera* integrated on the haloplate*in syngo CT VA40 known as Patientobservation camera
Moodlight	Illumination Moodlight to enhancepatient comfort supportedintegrated as a ring with LED lightinto the gantry front		Illumination Moodlight to enhancepatient comfort supportedIntegrated on the Halo
CARE Moodlight	LED lights integrated on the gantryfront cover indicating:• System startup• Scan countdown• Radiation on		n.a.
Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMgo.Sim	SOMATOMgo.Open Pro	SOMATOMgo.Sim	SOMATOMgo.Open Pro
scanner	Whole body Computed Tomography(CT) Scanner System		Whole body Computed Tomography(CT) Scanner System
SystemConfiguration	Single Source		Single Source
Environment of Use	Professional Healthcare Facility		Professional Healthcare Facility
GeneratorMax. power (kW)	75		75
Detector	Stellar		Stellar
technology	based on UFC (Ultra Fast Ceramic)		based on UFC (Ultra Fast Ceramic)
Detectorvolume coverage(mm)	19.2	38.4	19.2	38.4
Detectorphysical rows	32	64	32	64
DetectorSlice width (mm)	0.6	0.6	0.6	0.6
DetectorDAS channel no.	920	920	920	920
DetectorImage slices	64	128	64	128
Tubetechnology	Athlon		Athlon
TubekV steps	70 to 140 (in 10 kV steps)		70 to 140 (in 10 kV steps)
TubeMax. current (mA)	825		825
Tube	• 1.1 x 1.2 / 7°• 0.8 x 0.8 / 7°		• 1.1 x 1.2 / 7°• 0.8 x 0.8 / 7°
focus	• 0.8 x 0.8 / 7°		• 0.8 x 0.8 / 7°
Tube	7		7
Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMgo.Sim	SOMATOMgo.Open Pro	SOMATOMgo.Sim	SOMATOMgo.Open Pro
Heat storagecapacity (MHU)
TubeCooling rate (kHU/min)	Up to 1700		Up to 1700
GantryBore size	85		85
GantryScan FoV (cm)	60		60
GantryExtended FoV (cm)	85		85
GantryRot. time (sec)	0.35, 0.5, 1.0		0.35, 0.5, 1.0
GantryTilt (degree)	+/- 30-30° to +25° with optional 307 kgpatient table		+/- 30-30° to +25° with optional 307 kgpatient table
Patient tableType	Vario 2 (2000 mm)Vario RT (1600 mm)with table extension		Vario 2 (2000 mm)Vario RT (1600 mm)with table extension
Patient tableMax. weightcapacity (kg)	Vario 2: 307Vario RT: 227		Vario 2: 307Vario RT: 227
Max. scan lengthtopogram	1680 mm with table extension2080 mm with table extension		1680 mm with table extension2080 mm with table extension
Max. scan lengthImage acquisition	Max. 1600 mm with patient tableextensionMax. 2000 mm with patient tableextension		Max. 1600 mm with patient tableextensionMax. 2000 mm with patient tableextension
Spectral filtration	Tin Filter	Combined TinFilter/Split filter	Tin Filter	Combined TinFilter/Split filter
High Power 70/High Power 80	825 (@70 kV)825 (@ 80 kV)	Combined TinFilter/Split filter	825 (@70 kV)825 (@ 80 kV)	Combined TinFilter/Split filter
Hardware property	Subject deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM go. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMgo.Sim	SOMATOMgo.Open Pro	SOMATOMgo.Sim	SOMATOMgo.Open Pro
FAST 3D Camera	option for patient positioning withFAST 3D Camera:• ceiling mounted, modified design		option for patient positioning withFAST 3D Camera:• ceiling mounted
x-ray foot switch	Option to trigger hands-freescanning		Option to trigger hands-freescanning
Table foot switch	Option for table patient movement		Option for table patient movement
i-joystick	Option for patient tablemovements, including an electricalconnection for the tablet dockwhich allows charging the tabletwhen mounted.		Option for patient tablemovements, including an electricalconnection for the tablet dockwhich allows charging the tabletwhen mounted.
Tablet dock	Option for mounting of the tableton the patient table.		Option for mounting of the tableton the patient table.
CARE Breathe	n.a.		n.a.
CARE 2D camera	Patient observation cameraintegrated on gantry frontin syngo CT VB10 the patientobservation camera is renamed asCARE 2D camera		Patient observation cameraintegrated on gantry front

{16}------------------------------------------------

Image /page/16/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a cluster of orange dots.

{17}------------------------------------------------

Image /page/17/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

{18}------------------------------------------------

Image /page/18/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" are several orange dots of varying sizes.

{19}------------------------------------------------

Image /page/19/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.

Table 7: Comparison of technical hardware characteristics between subject devices SOMATOM go.Sim and SOMATOM go.Open Pro with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40.

{20}------------------------------------------------

Image /page/20/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a series of orange dots arranged in a circular pattern.

{21}------------------------------------------------

Image /page/21/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

{22}------------------------------------------------

Image /page/22/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

Table 8: Comparison of technical hardware characteristics between subject devices SOMATOM X.ceed with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40 (K211373).

Hardwareproperty	Subject deviceSOMATOM X. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM X. Platformwith SOMARIS/10 syngo CT VA40(K211373)
			SOMATOMX.cite	SOMATOMX.ceed
scanner	Whole body Computed Tomography(CT) Scanner System		Whole body Computed Tomography(CT) Scanner System
SystemConfiguration	Single Source		Single Source
Environment ofUse	Professional Healthcare Facility		Professional Healthcare Facility
GeneratorMax. power (kW)	90 kW or 105 kW	105 kW or 120kW	90 kW or 105 kW	105 kW or 120kW
Detectortechnology	StellarInfinity		StellarInfinity
Detectorvolume coverage	38.4 mm		38.4 mm
Detectorphysical rows	64rows		64
DetectorSlice width	0.6 mm		0.6 mm
DetectorDAS channel no.	840	920	840	920
DetectorImage slices	128		128
Tubetechnology	Vectron		Vectron
TubekV steps	70–140 kV in 10 kV steps		70–140 kV in 10 kV steps
TubeMax. current	1100 mA (for 90kW)1200 mA (for 105kW)	1200 mA (for 90kW)1300 mA (for 105kW)	1100 mA (for 90kW)1200 mA (for 105kW)	1200 mA (for 90kW)1300 mA (for 105kW)
Tubefocus	• 0.6 x 0.7 / 8°• 0.8 x 1.1 / 8°	• 0.4 x 0.5 / 8°• 0.6 x 0.7 / 8°	• 0.6 x 0.7 / 8°• 0.8 x 1.1 / 8°	• 0.4 x 0.5 / 8°• 0.6 x 0.7 / 8°
Hardwareproperty	Subject deviceSOMATOM X. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM X. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMX.cite	SOMATOMX.ceed	SOMATOMX.cite	SOMATOMX.ceed
		• 0.8 x 1.1 / 8°		• 0.8 x 1.1 / 8°
TubeHeat storagecapacity	higher than 30 MHU		higher than 30 MHU
TubeCooling rate(MHU/ min)	2.7 MHU / min	2.7 MHU / min	2.7 MHU / min	2.7 MHU / min
GantryBore size	82		82
GantryScan FoV (cm)	50		50
GantryExtended FoV(cm)	81.5		81.5
GantryRot. time (sec)	0.3, 0.5, 1.0	0,25, 0.3, 0.5, 1.0	0.3, 0.5, 1.0	0,25, 0.3, 0.5, 1.0
GantryTilt (degree)	+/- 25+/-30 (only with Vitus)		+/- 25+/-30 (only with Vitus)
Patient tableType	Vario RT (1600mm)Vitus (2000 mm)Vario 2 (2000mm)	Vario RT (1600mm)Vitus (2000 mm)Vario 2.D (2000mm)	Vario RT (1600mm)Vitus (2000 mm)Vario 2 (2000mm)	Vario RT (1600mm)Vitus (2000 mm)Vario 2.D (2000mm)
Patient tableInstallationoption	Regularinstallation(Vario RT, Vario 2and Vitus):474 mmInstallationoption withextendeddistance (Vitus):674 mm (474 mm)	Regularinstallation(Vario RT, Vario 2and Vitus):474 mmInstallationoption withextendeddistance (Vitus):674 mm (474 mm)	Regularinstallation(Vario RT, Vario 2and Vitus):474 mm	Regularinstallation(Vario RT, Vario 2and Vitus):474 mm
Hardwareproperty	Subject deviceSOMATOM X. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM X. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMX.cite	SOMATOMX.ceed	SOMATOMX.cite	SOMATOMX.ceed
Patient tableMax. weightcapacity (kg)	227 (Vario RT)340 (Vitus)307 (Vario 2)	227 (Vario RT)340 (Vitus)307 (Vario 2.D)	227 (Vario RT)307 (Vitus)307 (Vario 2)	227 (Vario RT)307 (Vitus)307 (Vario 2.D)
Max. scan lengthtopogram	1680 mm (VarioRT)2080 mm withtable extension(Vario 2)2080 mm (Vitus)	1680 mm (VarioRT)2080 mm withtable extension(Vario 2.D)2080 mm (Vitus)	1680 mm (VarioRT)2080 mm withtable extension(Vario 2)2080 mm (Vitus)	1680 mm (VarioRT)2080 mm withtable extension(Vario 2.D)2080 mm (Vitus)
Max. scan lengthImage acquisition	1600 mm (VarioRT)2000 mm (Vitus)2000 mm (Vario2)with tableextension	1600 mm (VarioRT)2000 mm (Vitus)2000 mm (Vario2.D)with tableextension	1600 mm (VarioRT)2000 mm (Vitus)2000 mm (Vario2)with tableextension	1600 mm (VarioRT)2000 mm (Vitus)2000 mm (Vario2.D)with tableextension
Spectral filtration	Combined TinFilter / SplitFilter, and extraTin Filter	Combined TinFilter / SplitFilter, and extraTin Filter	Combined TinFilter / SplitFilter, and extraTin Filter	Combined TinFilter / SplitFilter, and extraTin Filter
FAST 3D Camera	option for patient positioning withFAST 3D Camera:ceiling mounted, new design		option for patient positioning withFAST 3D Camera:ceiling mounted
High Power 70/High Power 80	Generator 90kW:up to 1100 mA(@70 kV)up to 1100 mA(@80 kV)Generator 105kW:up to 1200 mA(@70 kV)	Generator 105kW:up to 1200 mA(@70 kV)up to 1200 mA(@80 kV)Generator 120kW:up to 1300 mA(@70 kV)	Generator 90kW:up to 1100 mA(@70 kV)up to 1100 mA(@80 kV)Generator 105kW:up to 1200 mA(@70 kV)	Generator 105kW:up to 1200 mA(@70 kV)up to 1200 mA(@80 kV)Generator 120kW:up to 1300 mA(@70 kV)
Hardwareproperty	Subject deviceSOMATOM X. Platformwith SOMARIS/10 syngo CT VB10		Primary predicate deviceSOMATOM X. Platformwith SOMARIS/10 syngo CT VA40(K211373)
	SOMATOMX.cite	SOMATOMX.ceed	SOMATOMX.cite	SOMATOMX.ceed
	up to 1200 mA(@80 kV)	up to 1300 mA(@80 kV)	up to 1200 mA(@80 kV)	up to 1300 mA(@80 kV)
x-ray foot switch	Option to trigger hands-free scanning		Option to trigger hands-free scanning
Table foot switch	Option for table patient movement		Option for table patient movement
i-joystick	Option for patient table movements,including an electrical connection forthe tablet dock which allows chargingthe tablet when mounted.		Option for patient table movements,including an electrical connection forthe tablet dock which allows chargingthe tablet when mounted.
Tablet dock	Option for mounting of the tablet onthe patient table.		Option for mounting of the tablet onthe patient table.
CARE 2D camera	Patient observation cameraintegrated on gantry frontin syngo CT VB10 the patientobservation camera is renamed asCARE 2D camera		Patient observation cameraintegrated on gantry front

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Table 9: Comparison of software characteristics between the subject with software version syngo CT VB10 and predicate devices with software version syngo CT VA40 of the SOMATOM go. Platform.

Software property	Subject device	Primary predicate device
	SOMATOM go.Now	SOMATOM go.Now
	SOMATOM go.Up	SOMATOM go.Up
	SOMATOM go.All	SOMATOM go.All
	SOMATOM go.Top	SOMATOM go.Top
	SOMATOM go.Sim	SOMATOM go.Sim
	SOMATOM go.Open Pro	SOMATOM go.Open Pro
	SOMATOM X.cite	SOMATOM X.cite
	SOMATOM X.ceed	SOMATOM X.ceed
	with SOMARIS/10 syngo CT VB10	with SOMARIS/10 syngo CT VA40(K211373)
Operating System	Windows basedSOMARIS/10 syngo CT VB10Note: the short version syngo CT VB10 is also used as labeling information	Windows basedSOMARIS/10 syngo CT VA40Note: the short version syngo CT VA40 is also used as labeling information
Workplace	syngo Acquisition Workplace (ICS) named as "myExam Console"Image Reconstruction System (IRS)2nd workplace option named as "myExam Satellite" with Remote Recon function	syngo Acquisition Workplace (ICS) named as "myExam Console"Image Reconstruction System (IRS)2nd workplace option named as "myExam Satellite"
Standard systemsoftware	• syngo Examination• syngo Viewing• syngo Filming• syngo Archiving & Network	• syngo Examination• syngo Viewing• syngo Filming• syngo Archiving & Network
Detector firmware	Stellar detector firmware supported	Stellar detector firmware supported
Teamplay	Support of Teamplay protocols	Support of Teamplay protocols
Protocols	Support of:• Protocols for Radiation Therapy Planning support patient marking• Protocols that allow scanning with support of an external respiratory gating system (ANZAI, Varian RGSC)	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)
Software property	Subject device	Primary predicate device
	SOMATOM go.Now	SOMATOM go.Now
	SOMATOM go.Up	SOMATOM go.Up
	SOMATOM go.All	SOMATOM go.All
	SOMATOM go.Top	SOMATOM go.Top
	SOMATOM go.Sim	SOMATOM go.Sim
	SOMATOM go.Open Pro	SOMATOM go.Open Pro
	SOMATOM X.cite	SOMATOM X.cite
	SOMATOM X.ceed	SOMATOM X.ceed
	with SOMARIS/10 syngo CT VB10	with SOMARIS/10 syngo CT VA40(K211373)
	Protocol supporting contrast bolus-triggered data acquisition Contrast media protocols (including coronary CTA) Pediatric Protocols Flex Dose Profile Turbo Flash Spiral Dual Energy acquisition (TwinBeam DE and TwinSpiral DE) Dynamic imaging (Flex 4D Spiral) Protocols supporting CT Intervention (scan modes: i-sequence, i-spiral, i-Fluoro) Protocols supporting Cardiac Scanning Protocols for DirectBreathhold	Protocol supporting contrast bolus-triggered data acquisition Contrast media protocols (including coronary CTA) Pediatric Protocols Flex Dose Profile Turbo Flash Spiral Dual Energy acquisition (TwinBeam DE and TwinSpiral DE) Dynamic imaging (Flex 4D Spiral) Protocols supporting CT Intervention (scan modes: i-sequence, i-spiral, i-Fluoro) Protocols supporting Cardiac Scanning
Advanced Reconstruction	Recon&GO:- Spectral Recon (Dual EnergyReconstruction from photon-counting data) / including VirtualUnenhanced, Monoenergetic plus- Inline Results DE SPP (SpectralPost-Processing with photon-counting image data)- Inline Anatomical ranges(Parallel/Radial) incl. VirtualUnenhanced, Monoenergetic plus- Inline Spine and Rib Ranges- Inline table and bone removal	Recon&GO:- Spectral Recon (Dual EnergyReconstruction from photon-counting data) / including VirtualUnenhanced, Monoenergetic plus- Inline Results DE SPP (SpectralPost-Processing with photon-counting image data)
Image viewing	CT View&GO offers:	CT View&GO offers:
Software property	Subject device	Primary predicate device
	SOMATOM go.Now	SOMATOM go.Now
	SOMATOM go.Up	SOMATOM go.Up
	SOMATOM go.All	SOMATOM go.All
	SOMATOM go.Top	SOMATOM go.Top
	SOMATOM go.Sim	SOMATOM go.Sim
	SOMATOM go.Open Pro	SOMATOM go.Open Pro
	SOMATOM X.cite	SOMATOM X.cite
	SOMATOM X.ceed	SOMATOM X.ceed
	with SOMARIS/10 syngo CT VB10	with SOMARIS/10 syngo CT VA40(K211373)
	- basic post-processing viewer (CTView&GO)	- basic post-processing viewer (CTView&GO)
	- 2D and 3D (MPR, VRT, MIP andminIP)	- 2D and 3D (MPR, VRT, MIP andminIP)
	- Evaluation tools, Filming, Printing	- Evaluation tools, Filming, Printing
	- Interactive Spectral Imaging (ISI)
	- Basic visualization tools: EndoView
	- Basic manipulation tools: DE ROI,ROI HU, Average
Post-Processinginterface	• Recon&GO Inline ResultsSoftware interface to post-processing algorithms which areunmodified when loaded onto theCT scanners and 510(k) cleared asmedical devices in their own right.	• Recon&GO Inline ResultsSoftware interface to post-processing algorithms which areunmodified when loaded onto theCT scanners and 510(k) cleared asmedical devices in their own right.
	• software interfaces for post-processing functionalities toprovide advanced visualizationtools to prepare and processmedical images for diagnosticpurpose.	• software interfaces for post-processing functionalities toprovide advanced visualizationtools to prepare and processmedical images for diagnosticpurpose.
	Note: The clearance of standaloneAdvanced Visualization Applicationsoftware is mandatory precondition.	Note: The clearance of standaloneAdvanced Visualization Applicationsoftware is mandatory precondition.
	These advanced visualization toolsare designed to support thetechnician & physician in thequalitative and quantitativemeasurement & analysis of clinicaldata acquired and reconstructed by	These advanced visualization toolsare designed to support thetechnician & physician in thequalitative and quantitativemeasurement & analysis of clinicaldata acquired and reconstructed by
Software property	Subject device	Primary predicate device
	SOMATOM go.Now	SOMATOM go.Now
	SOMATOM go.Up	SOMATOM go.Up
	SOMATOM go.All	SOMATOM go.All
	SOMATOM go.Top	SOMATOM go.Top
	SOMATOM go.Sim	SOMATOM go.Sim
	SOMATOM go.Open Pro	SOMATOM go.Open Pro
	SOMATOM X.cite	SOMATOM X.cite
	SOMATOM X.ceed	SOMATOM X.ceed
	with SOMARIS/10 syngo CT VB10	with SOMARIS/10 syngo CT VA40(K211373)
	Computed Tomography scanners.Additional information regardingthe points of interface and inputsfor this feature is provided inSection 16.	Computed Tomography scanners.Additional information regardingthe points of interface and inputsfor this feature is provided inSection 16.
Cybersecurity	IT Hardening	IT Hardening
HD FoV	HD FoV 4.0	HD FoV 4.0
Standardtechnologies	• FAST technologies• CARE technologies• GO technologies	• FAST technologies• CARE technologies• GO technologies
IterativeReconstructionMethods	ADMIRE*SAFIREiMAR	ADMIRE*SAFIREiMAR
	*supported in SOMATOM go.All,SOMATOM go.Top, SOMATOMgo.Sim, SOMATOM go.Open Pro,SOMATOM X.cite and SOMATOMX.ceed	*supported in SOMATOMgo.All,SOMATOM go.Top,SOMATOM X.cite and SOMATOMX.ceed
Matrix sizes	256 x 256 pixels512 x 512 pixels768 x 768 pixels1024 x 1024 pixels (PrecisionMatrix)	256 x 256 pixels512 x 512 pixels768 x 768 pixels1024 x 1024 pixels (PrecisionMatrix)
DirectDensity™	DirectDensity™	DirectDensity™
Software property	Subject device	Primary predicate device
	SOMATOM go.Now	SOMATOM go.Now
	SOMATOM go.Up	SOMATOM go.Up
	SOMATOM go.All	SOMATOM go.All
	SOMATOM go.Top	SOMATOM go.Top
	SOMATOM go.Sim	SOMATOM go.Sim
	SOMATOM go.Open Pro	SOMATOM go.Open Pro
	SOMATOM X.cite	SOMATOM X.cite
	SOMATOM X.ceed	SOMATOM X.ceed
	with SOMARIS/10 syngo CT VB10	with SOMARIS/10 syngo CT VA40(K211373)
	(including relative electron densityand relative mass density)	(including relative electron densityand relative mass density)
Breath-holdtechnique	Respiratory Motion Managementsupport breath hold triggered spiralscans with manual breath holdtriggered examinations.	Respiratory Motion Managementsupport breath hold triggered spiralscans with manual breath holdtriggered examinations.
	Direct Breathold: externallytriggered workflow to start a spiralscan by receiving a trigger signalfrom an external gating device.
	*Note: Direct Breathold is notavailable for SOMATOM go.Now

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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 go. Platform and SOMATOM X. Platform with syngo CT VB10, are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.

VIII. Performance Data

Non-Clinical Testing

Non-clinical testing, (integration and functional) including phantom tests were conducted for the SOMATOM go. Platform and SOMATOM X. Platform during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

The general purpose of each test 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

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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) .
. Legal and Regulatory test

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 are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in Table 10 below.

Table 10: Non-clinical performance testing (bench testing).
-------------------------------------------------------------	--	--	--	--

Feature/Non-clinicalsupportive testing	Bench Testing performed
FAST 3D Camera /FAST IntegratedWorkflow	The bench test evaluates and compares the accuracy of the three sub-features FAST Isocentering, FAST Range, and FAST Direction to theaccuracy of the predicate device with syngo CT VA40 using the oldcamera hardware and the then only available ceiling mount.
	The objectives of the bench test are to demonstrate that the FAST 3DCamera feature of the subject device with SOMARIS/10 syngo CT VB10,where the algorithms have been optimized for a new camera hardwarein two mounting positions, achieves comparable results as the predicatedevice with syngo CT VA40.
	The FAST Isocentering accuracy of the subject device with syngo CT VB10is comparable to the predicate device with syngo CT VA40, regardless ofthe camera mounting position.
	For the FAST Range feature, the detection accuracy of all body regionboundaries is comparable between the subject device with syngo CTVB10 and predicate device with syngo CT VA40. In the gantry mountingposition, the legs are often occluded by the torso when the patient islying head-first on the table. This is not a severe limitation, as legexaminations are usually performed feet-first.
	The FAST Direction pose detection results are of comparable accuracy forsubject and predicate device, regardless of the camera mountingposition.
	Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy tothe SOMARIS/10 syngo CT VA40 predicate for the new FAST 3D Camerahardware, also in the new gantry position.
Feature/Non-clinicalsupportive testing	Bench Testing performed
Multi-Purpose Table	A CT system with extended distance between CT gantry and patient tablebase plus a mobile C-arm system were combined to evaluate thetechnical feasibility and possible limitations of this combination.The range of possible movement for the mobile C-arm in differentpositions between CT gantry and patient table was tested anddocumented by measurement of angles.Based on the test results it can be concluded that a CT scanner, equippedwith a Multi-Purpose (Vitus) Patient Table, which is installed withenhanced distance (674 mm) to the CT gantry and offers the iCT modefunctionality, provides sufficient freedom of movement for a mobile C-arm X-ray system to be used for clinical routine without any significantlimitations for the myNeedle Lasers or FAST 3D Camera.
Direct Breathhold	The test results showed that using the Direct Breathhold functionality, aspiral scan can automatically be triggered from an external respiratorygating device. The actual scan remains unchanged, and the object iscorrectly depicted in the resulting image.
ZeeFree	The bench tests evaluate the performance of ZeeFree reconstruction.The objectives of the tests are to demonstrate:that the number of artefacts which can be attributed to a stackmisalignment (e.g. discontinuities in vessel structures,anatomical steps at air-soft-tissue interfaces, doubling of vesselor other anatomy) and which are often caused by incompletepatient breath-hold can be reduced in a "Cardiac Stack ArtefactCorrection" (SAC) reconstruction compared to the standardreconstruction with otherwise matching reconstructionparameters. that no artefacts are introduced by a SAC reconstruction. The test results show: If misalignment artefacts are identified in non-correctedstandard ECG-gated reconstructed sequence or spiral images,the feature "Cardiac Stack Artefact Correction" (SAC, marketingname: ZeeFree) enables optional stack artefact correctedimages, which reduce the number of alignment artefacts. The SAC reconstruction does not introduce new artefacts, whichwere previously not present in the non-corrected standardreconstruction. The SAC reconstruction does realize equivalent image quality inquantitative standard physics phantom-based measurements(ACR, Gammex phantom) in terms of noise, homogeneity, high-contrast resolution, slice thickness and CNR compared to a non-corrected standard reconstruction
Feature/Non-clinicalsupportive testing	Bench Testing performed
	The SAC reconstruction does realize equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects compared to a non-corrected standard reconstruction. The SAC algorithm can be successfully applied to phantom data if derived from a suitable motion phantom demonstrating its correct technical function on the tested device. The SAC algorithm is independent from the physical detector width of the acquired data
myNeedle Guide(with myNeedleDetection)	Tests were performed to ensure clinical usability of the myNeedle Guide needle detection algorithm. Two individual tests were performed. The accuracy of the automatic needle detection algorithm was tested. The reduction of necessary user interactions for navigating to a needle-oriented view with and without the support of the automatic needle detection algorithm was analyzed.It has been shown that the algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases.Further, the results of this bench test clearly show that the auto needle detection functionality reduces the number of interactions steps needed to generate a needle-aligned view in the CT Intervention SW.With successful Al-based needle tip detection, no user interaction is needed to achieve needle-aligned view during needle progression. Additional manual adjustment (fine tuning) of the needle-aligned view is always possible.

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A list of recognized and general consensus standards considered for the subject devices is provided as Table 11 and Table 12 below.

Table 11: Recognized Consensus Standards.

Date ofEntry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
12/19/2022	12-349	NEMA	PS 3.1 - 3.20 2022d	Digital Imaging andCommunications in Medicine(DICOM) Set
07/06/2020	12-325	NEMA	XR 25-2019	Computed Tomography DoseCheck
07/06/2020	12-330	NEMA	XR 28-2018	Supplemental Requirementsfor User Information andSystem Function Related toDose in CT
Date ofEntry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
12/23/2019	12-328	IEC	61223-3-5 Edition2.0 2019-09	Evaluation and routine testingin medical imagingdepartments - Part 3-5:Acceptance tests andconstancy tests - Imagingperformance of computedtomography X-ray equipment[Including: TechnicalCorrigendum 1 (2006)]
03/14/2011	12-226	IEC	61223-2-6 SecondEdition 2006-11	Evaluation and routine testingin medical imagingdepartments - Part 2-6:Constancy tests - Imagingperformance of computedtomography X-ray equipment
01/14/2014	12-269	IEC	60601-1-3 Edition2.1 2013-04	Medical electrical equipment- Part 1-3: Generalrequirements for basic safetyand essential performance -Collateral Standard: Radiationprotection in diagnostic X-rayequipment
06/27/2016	12-302	IEC	60601-2-44 Edition3.2: 2016	Medical electrical equipment- Part 2-44: Particularrequirements for the basicsafety and essentialperformance of x-rayequipment for computedtomography
12/23/2019	5-125	ANSI AAMIISO	14971: 2019	Medical devices - Applicationsof risk management tomedical devices
		ISO	14971 Third Edition2019-12	Medical devices - Applicationof risk management tomedical devices
01/14/2019	13-79	ANSI AAMIIEC	62304:2006/A1:2016	Medical device software -Software life cycle processes[Including Amendment 1(2016)]
		IEC	62304 Edition 1.12015-06	Medical device software -Software life cycle processes
Date ofEntry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
			CONSOLIDATEDVERSION
07/09/2014	19-46	ANSI AAMI	ES60601-1:2005/(R)2012 &A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012(Cons. Text) [Incl.AMD2:2021]	Medical electrical equipment- Part 1: Generalrequirements for basic safetyand essential performance(IEC 60601-1:2005, MOD)[Including Amendment 2(2021)]
09/17/2018	19-36	ANSI AAMIIEC	60601-1-2:2014[Including AMD1:2021]	Medical electrical equipment- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral Standard:Electromagnetic disturbances- Requirements and tests
		IEC	60601-1-2 Edition4.1 2020-09CONSOLIDATEDVERSION	Medical electrical equipment- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral Standard:Electromagnetic disturbances- Requirements and tests
12/23/2016	5-129	ANSI AAMIIEC	62366-1:2015+AMD1:2020(Consolidated Text)	Medical devices Part 1:Application of usabilityengineering to medicaldevices, includingAmendment 1
		IEC	62366-1 Edition 1.12020-06CONSOLIDATEDVERSION	Medical devices - Part 1:Application of usabilityengineering to medicaldevices
07/09/2014	12-273	IEC	60825-1 Edition 2.02007-03	Safety of laser products - Part1: Equipment classification,and requirements
12/21/2020	5-132	IEC	60601-1-6 Edition3.2 2020-07CONSOLIDATEDVERSION	Medical electrical equipment- Part 1-6: Generalrequirements for basic safetyand essential performance -Collateral standard: Usability
12/23/2019	12-309	IEC	60601-2-28 Edition2.0 2017-06	Medical electrical equipment- Part 2-28: Particular
Date ofEntry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
				requirements for the basicsafety and essentialperformance of X-ray tubeassemblies for medicaldiagnosis
12/20/2021	12-341	IEC	62563-1 Edition 1.22021-07CONSOLIDATEDVERSION	Medical electrical equipment- Medical image displaysystems - Part 1: Evaluationmethods

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Table 12: General Use Consensus Standards.

StandardDevelopingOrganization	Standard DesignationNumber and Date	Title of Standard	How was Standard Used
IEC	60601-1:2005+A1:2012+A2:2020	Medical electricalequipment - part 1:general requirementsfor basic safety andessential performance	ANSI AAMI ES60601-1:2005/(R)2012 &A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012 (Cons.Text) [Incl. AMD2:2021]
IEC/ISO	17050-1	Conformity Assessment– Supplier's declarationof conformity – Part 1:General requirements	Declaration ofconformance to FDArecognized consensusstandards.
IEC/ISO	17050-2	Conformity assessment– Supplier's declarationof conformity – Part 2:Supportingdocumentation.	General consensusstandards not currentlyrecognized by FDA.

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A list of applicable guidance documents considered for this submission is provided as Table 13 below.

Table 13: FDA Guidance Document and Effective Date

FDA Guidance Document	Issue date
User Fees and Refunds for Premarket Notification Submissions (510(k)s)	10/05/2022
Refuse to Accept Policy for 510(k)s	04/21/2022
Electronic Submission Template for Medical Device 510(k) Submissions	10/2/2023
Deciding When to Submit a 510(k) for a Change to an Existing Device	10/25/2017
Deciding When to Submit a 510(k) for a Software Change to an ExistingDevice	10/25/2017
The 510(k) Program: Evaluating Substantial Equivalence in PremarketNotifications [510(k)]	07/28/2014
Content of Premarket Submissions for Software Contained in MedicalDevices	06/14/2023
Off-The-Shelf Software Use in Medical Devices	08/11/2023
Applying Human Factors and Usability Engineering to Medical Devices	02/03/2016
Pediatric Information for X-ray Imaging Device Premarket Notifications	11/28/2017
Cybersecurity in Medical Devices: Quality System Considerations andContent of Premarket Submissions	09/27/2023
Electromagnetic Compatibility (EMC) of Medical Devices	06/06/2022
Design Considerations and Pre-market Submission Recommendations forInteroperable Medical Devices	09/06/2017
Appropriate Use of Voluntary Consensus Standards in PremarketSubmissions for Medical Devices	09/14/2018

Verification and Validation

Software documentation at an Enhanced Documentation level per FDA's Guidance Document "Content of Premarket Submissions for Software Contained in Medical Devices" issued on June 14, 2023 is 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.

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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 "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued on September 27, 2023 is included within this submission.

Wireless Coexistence Testing

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 iPad 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 SOMATOM go. Platform and SOMATOM X. Platform 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 FDA guidance 'Radio Frequency Wireless Technology in Medical Devices" Siemens has addressed the safety, effectiveness, and high likelihood of coexistence with other devices of this technology in our product design by our Risk Management Process, Failure Mode and Effects Analysis (FMEA) Process, and Requirement Engineering Process. As part of the risk management process, hazardous situations associated with the Scan&GO and its connection to the host system via Wi-Fi were addressed as part of the Risk Management process.

Testing for co-existence considered for following scenarios:

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

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

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Summary

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

IX. Conclusions

The predicate/secondary devices were cleared based on the results of non-clinical and clinical testing including verification and validation, phantom tests, validation on clinical images, and supportive literature. The non-clinical and clinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the subject devices SOMATOM go. Platform and SOMATOM X. Platform 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 perform comparably to the predicate devices currently marketed for the same intended use. Siemens believes that the data generated from the SOMATOM go. Platform and SOMATOM X. Platform testing supports a finding of substantial equivalence.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.