This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.

The images delivered by the system can be used by a trained staff as an aid in diagnosis.

Device Description

The SOMATOM On.site with software version syngo CT VB10 is a mobile computed tomography (CT) scanner system that will be offered in two variants:

. SOMATOM On.site for Intensive Care Unit (ICU) Mobile CT scanner affixed to a motorized trolley for use in hospital situations. The scanner can be moved from patient bed to patient bed to perform scanning at the point of care. Although it might be used in other environments like emergency rooms or angiography labs, the main location where this scanner will be used, will be the intensive care unit (ICU).
. SOMATOM On.site for Mobile Stroke Unit (MSU) Mobile CT Scanner that is mounted to the floor of a diagnostic room or vehicle. The system main place where the scanner will be mounted is in a mobile stroke unit (MSU), which is a specific type of ambulance.

The subject device SOMATOM On.site with SOMARIS/10 syngo CT VB10 is a mobile Computed Tomography X-ray Systems which features a continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM On.site with software SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for postprocessing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis and treatment preparation. The computer system integrated with the CT scanner is able to run optional post processing applications.

AI/ML Overview

The Siemens SOMATOM On.site (SOMARIS/10 syngo CT VB10) is a computed tomography (CT) X-ray system. The provided text describes the non-clinical testing performed to demonstrate the device's performance and substantial equivalence to predicate devices. The study focuses on evaluating specific upgraded software features (FAST kV, CARE Dose4D, X-CARE, ADMIRE).

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria	Reported Device Performance
FAST kV	Image Quality (Contrast-to-Noise Ratio): CNR values at 80 kV and 120 kV should be consistent (deviations well below 15%). Radiation Dose Reduction: Dose levels should be reduced at 80 kV, especially for the 'vascular' setting.	For iodine and calcium contrast material inserts in a cylindrical 20 cm water phantom, CNR values at 80 kV and 120 kV are consistent (deviations well below 15%). Dose levels at 80 kV are slightly reduced (-5%) with the 'bone/calcium' setting and substantially reduced (-44%) with the 'vascular' setting compared to 120 kV.
CARE Dose4D	Comparable performance of CARE Dose4D in SOMATOM On.site to the predicate device SOMATOM go.Up. CARE Dose4D should lead to reduced dose levels at consistent image quality.	Evaluation showed equivalent performance results for CARE Dose4D in the subject device SOMATOM On.site and the predicate device SOMATOM go.Up with respect to radiation dose (CTDIvol) and image noise levels. Clinical publications (not detailed here) already demonstrate dose reduction potential of CARE Dose4D.
X-CARE	Comparable performance of X-CARE in SOMATOM On.site to the predicate device SOMATOM go.Up. X-CARE should lead to reduced dose levels to the eye lenses at consistent image quality.	Evaluation showed equivalent performance results for X-CARE in the subject device SOMATOM On.site and the predicate device SOMATOM go.Up with respect to radiation dose (CTDIvol) and image noise levels. Clinical publications (not detailed here) already demonstrate organ dose reduction potential of X-CARE.
ADMIRE	Reduces image noise without noticeable loss of sharpness. Mean CT values, including water value, should not vary when ADMIRE is used instead of a weighted filtered back-projection (WFBP).	Water value and CT value of PTFE object remain constant with increasing ADMIRE strength settings and compared to WFBP. Sharpness, demonstrated with edge MTF, is constant with increasing ADMIRE strength setting and WFBP. Image noise decreases compared to WFBP and with increasing ADMIRE strength, while maintaining a Gaussian noise distribution for a natural image impression.

2. Sample Size for the Test Set and Data Provenance

The document describes phantom-based measurements for the non-clinical testing. Specific numerical sample sizes (e.g., number of scans, number of phantoms) are not explicitly provided beyond mentioning "a cylindrical 20 cm water phantom" and "PTFE object" for ADMIRE. The data provenance is not explicitly stated as retrospective or prospective, but given it's "bench testing" performed "during product development," it implies a prospective non-clinical study design. The "country of origin of the data" is not specified but is likely internal to Siemens Healthineers.

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

For non-clinical phantom studies, the concept of "experts establishing ground truth" as it would apply to clinical image interpretation is not directly applicable. The "ground truth" for these tests is established by:

Physical properties of the phantoms: The known composition and dimensions of the water and PTFE phantoms.
Established quantitative image quality metrics: Such as CNR, MTF, and noise measurements, which are objectively calculated by the system or analysis software based on internationally recognized standards.
Comparison to predicate device performance: For CARE Dose4D and X-CARE, performance is compared to the established and cleared predicate device, SOMATOM go.Up.

Therefore, no external clinical experts are mentioned for establishing ground truth in these specific non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable for non-clinical phantom studies based on objective quantitative measurements. The assessment is based on direct measurement results against pre-defined acceptance criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text describes non-clinical bench testing using phantoms, not clinical studies involving human readers or cases. Therefore, no MRMC study was performed, and no effect size for human reader improvement with/without AI assistance is reported.

6. Standalone Performance Study

Yes, the studies reported are standalone (algorithm only) performance evaluations of specific software features (FAST kV, CARE Dose4D, X-CARE, ADMIRE) on the SOMATOM On.site CT scanner, using phantoms. This is a non-human-in-the-loop assessment of the technical performance of the algorithms and hardware.

7. Type of Ground Truth Used

The ground truth used is primarily based on:

Known physical properties of phantoms: e.g., known dimensions, material composition (water, PTFE), and contrast agent concentrations.
Objective quantitative measurements: Metrics like Contrast-to-Noise Ratio (CNR), Modulation Transfer Function (MTF) for sharpness, and noise levels.
Performance of a predicate device: For CARE Dose4D and X-CARE, the performance of the predicate device (SOMATOM go.Up) serves as a benchmark for "comparable performance."

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its size. The features being evaluated (FAST kV, CARE Dose4D, X-CARE, ADMIRE) are algorithmic components of the CT system. While these algorithms might have been developed using various data, the document focuses on the validation testing of their performance on the new device, not their initial development or training. It states that ADMIRE was "originally approved with K133646," indicating it's an existing algorithm that has been integrated.

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

As no training set is explicitly mentioned or detailed in this document, the method for establishing its ground truth is also not provided. The focus is on the verification and validation of the integrated system.

Summary

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

September 3, 2024

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

Re: K241295

Trade/Device Name: SOMATOM On.site Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: July 31, 2024 Received: July 31, 2024

Dear Kenny Bello:

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.

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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).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241295

Device Name

SOMATOM On.site

Indications for Use (Describe)

This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.

The images delivered by the system can be used by a trained staff as an aid in diagnosis.

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/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 cluster of orange dots.

510(k) Summary for K241295

SOMATOM On.site CT Scanner System

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

Siemens Healthineers AG Siemensstr. 1 -OR- Rittigfeld 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335

Note: Descriptions in this submission use the short company name Siemens. Brand name on all products is Siemens Healthineers.

Submitter Contact Person:

Kenny M 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

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Image /page/5/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 pattern of orange dots arranged in a circular shape.

II. Device Name and Classification

Product name:	SOMATOM On.site
Trade name:	SOMATOM On.site
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 On. CT scanner systems(with SOMARIS/10 syngo CT VA35 software)
510(k) Number:	K193277
Clearance Date:	July 22, 2020
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subject devicedesign.

Secondary predicate device:

Trade Name:	SOMATOM go.Up (with SOMARIS/10 syngo CT VB10 software)
510(k) Number:	K233650
Clearance Date:	March 26, 2024
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:

K233650 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.

K193277 was a bundle submission with the following Siemens CT Scanner Systems: SOMATOM On.site and SOMATOM On.scene

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Image /page/6/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 cluster of orange dots arranged in a circular pattern.

IV. Device Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the SOMATOM On. platform cleared in K193277 (clearance date July 22nd, 2020).

In software version syngo CT VA35 (K193277), the SOMATOM On. platform consists of two Computer Tomography (CT) scanner systems: SOMATOM On.scene for Mobile Stroke Units and SOMATOM On.site with an optional motorized base for in-hospital usage.

With the new software version SOMARIS/10 synqo CT VB10, the two SOMATOM On. scanners are rebranded as one scanner model only, SOMATOM On.site. The brand name SOMATOM On.scene is not used anymore.

The SOMATOM On.site with software version syngo CT VB10 is a mobile computed tomography (CT) scanner system that will be offered in two variants:

. SOMATOM On.site for Intensive Care Unit (ICU) Mobile CT scanner affixed to a motorized trolley for use in hospital situations. The scanner can be moved from patient bed to patient bed to perform scanning at the point of care. Although it might be used in other environments like emergency rooms or angiography labs, the main location where this scanner will be used, will be the intensive care unit (ICU).
. SOMATOM On.site for Mobile Stroke Unit (MSU) Mobile CT Scanner that is mounted to the floor of a diagnostic room or vehicle. The system main place where the scanner will be mounted is in a mobile stroke unit (MSU), which is a specific type of ambulance.

SOMATOM On.site

SOMARIS/10 syngo CT VB10

A: for Intensive Care Unit (ICU)

Image /page/6/Figure/11 description: This image shows a Siemens Healthineers SOMATOM On.site mobile CT scanner. The scanner is white with orange accents and has a large, circular gantry. The gantry is open in the front, and there is a gray cover over the opening. The scanner is mounted on a wheeled base, making it easy to move around.

B: for Mobile Stroke Unit (MSU)

Image /page/6/Figure/13 description: The image shows a Siemens Healthineers SOMATOM On.site mobile head CT scanner. The scanner is white with an orange circular opening where the patient's head is placed for scanning. The Siemens Healthineers logo is visible at the top of the scanner.

Figure 1: SOMATOM On.site with software version SOMARIS/10 syngo CT VB10 in two variants. A: as a mobile CT scanner for Intensive Care Unit (ICU). The scanner is mounted on a trolley with wheels. B: as a mobile CT for Mobile Stroke Unit (MSU). The CT scanner is mounted in a vehicle.

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Image /page/7/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 arranged in a circular pattern.

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.

The platform software for SOMATOM On.site is syngo CT VB10 (SOMARIS/10 syngo CT VB10). It is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform SOMARIS/10 synqo CT VB10 is designed to provide a plugin interface to integrate potential advanced post-processing tasks, tools, or extendable functionalities.

New software version synqo CT VB10 (SOMARIS/10 synqo CT VB10) is a modified software version based on syngo CT VA35 (SOMARIS/10 syngo CT VA35) which was cleared for the predicate device in K193277.

Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as a mandatory exchange for the applicable existing SOMATOM On.site.

The subject device SOMATOM On.site will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use is same for subject and primary predicate device.

V. Indications for Use

This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.

The images delivered by the system can be used by a trained staff as an aid in diagnosis.

VI. Indications for Use Comparison

Subject Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 26 cm field-of-view, for the head and neck.

The images delivered by the system can be used by a trained staff as an aid in diagnosis.

Primary Predicate Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images by computed reconstruction of x-ray transmission data within a 25 cm field-of-view, primarily for the head and neck.

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Image /page/8/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. To the right of the word "Healthineers" is a graphic of orange dots.

The images delivered by SOMATOM On.site and On.scene can be used by a trained physician as an aid in diagnosis.

Secondary 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 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.

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:

Compared to the primary predicate device:

In the sentence "This computed tomography system is intended to generate and process crosssectional images by computed reconstruction of x-ray transmission data within a 25 cm field-of-view, for the head and neck.":

. "25 cm field-of-view" is replaced with "26 cm field-of-view". The field-of-view was inconsistently listed among the documents of the predicate device. However, 26 cm field-ofview is the correct field-of-view of the predicate device and the subject device.
. "primarily for the head and neck" is replaced with "for the head and neck". In contrast to the predicate device, the subject device is only intended for head and neck scans.

In the sentence "The images delivered by SOMATOM On.scene can be used by a trained physician as an aid in diagnosis ":

. "trained physician" is replaced 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 510(k) summary:

"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."

. "SOMATOM On.site and SOMATOM On.scene" have been replaced with "system", since with software version synqo CT VB10, the two SOMATOM On. scanners will be rebranded as one scanner model only.

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Image /page/9/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 below it. To the right of the word "Healthineers" are several orange dots arranged in a pattern.

Compared to the secondary predicate device:

The subject device does not contain the phrase "treatment preparation and radiation therapy planning" in the sentence "The images delivered by the system can be used by a trained staff as an aid in diagnosis." because SOMATOM On.site does not support intervention procedures and radiation therapy planning.
. SOMATOM On.site is not used in lung cancer screening. Therefore, the following part is not included in the indication for use statement of SOMATOM On.site.

"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."

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 VA35 software version which is cleared in K193277.

The SOMATOM On.site 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 On.site 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 VA35 cleared in K193277.

The intended use and fundamental scientific technology for the SOMATOM On.site remain unchanged from the predicate devices.

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

System Acquisition - Continuously rotating tube detector system
. Iterative Reconstruction – Support of various iterative reconstruction principles
A gantry translation system
Stellar Detector technology
Tin filtration technology
Power Generator
Remote Scan Control
Standard CARE technologies
Standard FAST technologies
Standard GO technologies
HD FoV ●

Compared to the predicate devices referenced in this submission, the subject device SOMATOM On.site with SOMARIS/10 syngo CT VB10 support the following modifications:

1. Modified hardware
1. Modified software
1. Modified accessories

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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 below it. To the right of the word "Healthineers" are several orange dots that are arranged in a pattern.

1. Modified indications for use
1. Rebranding as one scanner model with two configurations, ICU and MSU

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

Table 1: Overview of term definition

Term	Definition
Modified	The feature is modified from the predicate devices
Enabled	The feature is currently supported by other cleared Siemens CT systems. Thisfeature will be supported for the subject device with software versionSOMARIS/10 syngo CT VB10 and is unmodified from cleared version.
New	The feature is newly supported for Siemens CT Scanners and the subjectdevice

1) Modified Hardware

Table 2: Overview of hardware modifications of SOMATOM On.site with software version SOMARIS/10 syngo CT VB10 compared to the predicate devices.

#	Hardware property	Subject device
		SOMATOM On.Site(ICU and MSU variants)with SOMARIS/10 syngo CT VB10
1.	CARE 2D Camera	modified(compared to the secondary predicatedevice SOMATOM go.Up)
2.	Tin Filter for Topogram	enabled(compared to the secondary predicatedevice SOMATOM go.Up)

2) Modified Software (syngo CT VB10)

Table 3: Overview of software modifications of SOMATOM On.site with software version SOMARIS/10 syngo CT VB10 compared to the predicate devices.

#	Software property	Subject device
		SOMATOM On.Site(ICU and MSU variants)with SOMARIS/10 syngo CT VB10
1.	Check&GO – Metal detection	enabled
#	Software property	Subject device
		SOMATOM On.Site(ICU and MSU variants)with SOMARIS/10 syngo CT VB10(compared to the secondary predicatedevice SOMATOM go.Up)
2.	myExam Companion - myExamCompass/myExam Cockpit	enabled(compared to the secondary predicatedevice SOMATOM go.Up)
3.	Bolus Tracking	enabled(compared to the secondary predicatedevice SOMATOM go.Up)
4.	Test Bolus	enabled(compared to the secondary predicatedevice SOMATOM go.Up)
5.	ADMIRE	enabled(compared to the secondary predicatedevice SOMATOM go.Up)
6.	FAST kV	enabled(compared to the secondary predicatedevice SOMATOM go.Up)
7.	CARE Dose4D	enabled(compared to the secondary predicatedevice SOMATOM go.Up)
8.	X-CARE	enabled(compared to the secondary predicatedevice SOMATOM go.Up)
9.	FAST Planning	enabled(compared to the secondary predicatedevice SOMATOM go.Up)
10.	CT View&GO	modified(compared to the primary SOMATOMon.site and the secondary predicate deviceSOMATOM go.Up)
11.	Recon&GO	modified(compared to the primary SOMATOMon.site and the secondary predicate deviceSOMATOM go.Up)

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Image /page/12/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. To the right of the word "Healthineers" is a graphic of orange dots.

A tabular summary of the comparable hardware properties between the subject device On.site with software version syngo CT VB10 and the predicate devices are listed in Table 5 below (modifications are in gray shaded sections).

Toble 4: Comprison of hardware (HV) technologics between the subject device SOMATOM On.site with syltware version syngo CTVB10 ond the predicote devices.

Hardware (HW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. scannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
Scanner	Head sized computedtomography scanner withcontinuously rotating tubeand detector	Head sized computedtomography scanner withcontinuously rotating tubeand detector	Whole body computedtomography scanner withcontinuously rotating tubeand detector	Same as the primarypredicate device
System configuration	Single source	Single source	Single source	Same as the primaryand the secondarypredicate device
Use environment	Radiology suite, Operatingroom (OR), EmergencyDepartment/ Emergency room(ER/ED), clinic, patient rooms,exam rooms, mobile radiologyvehicles, Intensive Care Unit(ICU), and Mobile Stroke Unit(MSU)	Radiology suite, Operatingroom (OR), EmergencyDepartment/ Emergency room(ER/ED), clinic, patient rooms,exam rooms, mobile radiologyvehicles, Intensive Care Unit(ICU), and Mobile Stroke Unit(MSU)	Professional HealthcareFacility	Same as the primarypredicate device
X-ray tube	Stationary anode	Stationary anode	Rotary anode	Same as the primarypredicate device
Tubetechnology	Monoblock: Integrates tubeand generator to onecomponent	Monoblock: Integrates tubeand generator to onecomponent	Chronon	Same as the primarypredicate device
Hardware (HW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. scannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
Tubecurrent (mA)	1...25	3...25	13...400	Range of mA wasextended at the lowerend to increaseflexibility for scans withlower mA and thuslower dose especiallyfor topogram scans.
Tube voltagekV steps	80, 120	80, 120	80, 110, 130	Same as the primarypredicate device
tube cooling	Liquid	Air and liquid	Liquid	Same as the secondarypredicate deviceFocus on liquid coolingallows to get rid of aircooling and reduce thenumber ofcomponents in thesystem by reducing theair fan, which wasneeded.
Focal spot size (mm)	1.1 x 1.6	1.1 x 1.6	0.8 x 0.40.8 x 0.7	Same as the primarypredicate device
Generatorpower max (kW)	3	3	32	Same as the primarypredicate device
Hardware (HW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. scannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
Detectormaterial	Lightning UFC	Lightning UFC	Lightning UFC	Same as the primaryand the secondarypredicate device
Detectortechnology	Stellar based technology	Stellar based technology	Stellar based technology	Same as the primaryand the secondarypredicate device
Detectorphysical rows	32	32	32	Same as the primaryand the secondarypredicate device
DetectorZ axis coverage (mm)	24	24	22.4	Same as the primaryand the secondarypredicate device
Detectorslice width (mm)	0.75	0.75	0.7	Same as the primarypredicate device
DetectorDAS channel No./row	416	416	768	Same as the primarypredicate device
DetectorMax. number of slices	Acquired: 32Reconstructed: 32	Acquired: 32Reconstructed: 32	Acquired: 32Reconstructed: 64	Same as the primarypredicate device
Translation/table	Translation on fixed base	Translation on fixed base	Translating patient table	Same as the primarypredicate device
Max. scan range (cm)	25	25	160 or 200 depending on thepatient table used	Same as primarypredicate device
Hardware (HW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. scannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)

Gantryscan FoV (cm)	26	26	50	Same as the primarypredicate device
Gantryrotation time (sec)	1.0	1.0	0,8, 1.0, 1.5	Same as the primarypredicate device
Gantrybore diameter (cm)	35	35	70	Same as the primarypredicate device
Gantry tilt (degrees)	No tilt	No tilt	Yes (+/-25°)	Same as the primarypredicate device
Selectable filtration	Tin Filter/Tin Filtrationtechnology	N.A.	Tin Filter/Tin Filtrationtechnology	Same as the secondarypredicate deviceTin filtration allows tolower the dose ontopogram scans.
Recon speed(images/sec)	20 for FBP	13 for FBP	• 30 fps for FBP• 75 fps for FBP(depending on the IRS)	Recon speed increaseddue to new hardware(image reconstructionsystem) with increasedperformance
Spiral scan	yes	yes	yes	Same as the primarypredicate device
Hardware (HW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. scannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
System Configuration	Single source	Single source	Single source	Same as the primarypredicate device
Patient support	Patient support mountsdirectly to the scanner and ispre-aligned to alleviateimaging artifacts or loss ofquality	Patient support mountsdirectly to the scanner and ispre-aligned to alleviateimaging artifacts or loss ofquality	Patient support is part ofpatient table which ismounted to scanner and ispre-aligned laterally; requiresoperator to align vertically tocenter patient to alleviateimaging artifacts or loss ofquality	Same as the primarypredicate device
Radiation shielding	YesGantry shielded internally withleadExternally contain lead linedfull-length drapes to entirelycontain the scatteredradiation from all anglesOperator can stand at side ofmachine.Wearing of protectiveshielding is optional.	YesGantry shielded internally withleadExternally contain lead linedfull-length drapes to entirelycontain the scatteredradiation from all anglesOperator can stand at side ofmachine.Wearing of protectiveshielding is optional.	Norequires to be installed in ashielded room with door lightand interlock	Same as the primarypredicate device
CARE 2D Camera	integrated into the gantryfront to observe the patientduring examination	N/A	integrated into the gantryfront and back to observe thepatient during examination	EquivalentIn software versionsyngo CT VB10, a 2D
Hardware (HW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. scannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
				Camera hardware isintegrated into thegantry front. Thisallows to observe thepatient from the frontof the system whenthe front radiationshield was closed. Thebore light illuminatesthe bore so thepatient's face can beseen on the 2D Cameraimages.
Scanner Mobility
Mobile/ Fixed	Mobile/ fixed• SOMATOM On.site forIntensive Care Unit (ICU):Mobile CT scanner affixed toan optional motorized trolleyfor use in hospital traumasituations.• SOMATOM On.site forMobile Stroke Unit (MSU):Fixed CT Scanner that can bemounted to the floor of a	Mobile/ fixed• SOMATOM On.site:Mobile CT scanner affixed toan optional motorized trolleyfor use in hospital traumasituations.• SOMATOM On.scene:Fixed CT Scanner that can bemounted to the floor of adiagnostic room or vehicle,e.g. Mobile Stroke Unit (MSU)	fixed	Same as the primarypredicate deviceNote: Rebranding ofthe CT system asSOMATOM On.siteonly with two variants,ICU and MSU;mobile/fixed method isunchanged compared
Hardware (HW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. scannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
	diagnostic room or vehicle,e.g. Mobile Stroke Unit (MSU)			to the primarypredicate device.
Mobile method	2 independent motorized rearwheels with 2 front casterwheels	2 independent motorized rearwheels with 2 front casterwheels	N/A	Same as the primarypredicate device
Mobile speed	2.8 mph max	2.5 mph max	N/A	EquivalentSlightly increased by0.3 mph mobile speedto meet customers'satisfaction
Break	yes	yes	N/A	Same as the primarypredicate device
Drive handle	Yes (ICU variant)	Yes (ICU variant)	N/A	Same as the primarypredicate device
Integrated Drivecamera	Yes (ICU variant)	Yes (ICU variant)	N/A	Same as the primarypredicate device
Scanner power
External power	100 - 240 Vac50/60 Hz0.825 kW	100 - 240 Vac50/60 Hz1.2 kW	200 - 400 VAC50/60 Hz50 kW	EquivalentReduced externalpower consumptiondue to new batterytechnology
Hardware (HW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. scannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
Internal powerstorage	1 x 48 V Lithium-ion battery	4 x 12 V sealed lead-acidbattery	No	Change of technologyfrom lead-acidbatteries to Lithium-ion batteries in orderto increase batterycapacity and lifetime.
Electrical safety	Circuit breakers and isolationtransformer	Circuit breakers and isolationtransformer	Circuit breakers	Same as the primarypredicate device
EMERGENCY-stop key	yes	yes	yes	Same as the primarypredicate device
Operator Interface
Operator ControlInterface on Scanner	Integrated touch monitor +button panel	integrated touch screen tabletPC + physical keyboard+button panel	Removable touch screen +button panel	Changed from tablet totouch monitor &desktop PC setup.Increased performanceof desktop PC, biggerand tiltable screen.
Remote control	Wired remote control forservice	Optional wired	Wired/ wireless	Same as the primarypredicate device
Workstation	No, access through integratedtouch monitor	No, access through tablet PC	syngo Acquisition Workplace	Equivalent to theprimary deviceThe display in thesubject device is a
Hardware (HW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. scannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
				touch monitor while inthe primary predicatedevice the display wasa tablet PC. Theinterface provides asimilar userexperience, while theperformance of thebackend PC could beincreased.
Keyboard/mouse	Virtual keyboard and touchinteraction on integratedtouch monitor	included	included	EquivalentIn the subjective devicekeyboard and mouseinteractions are allperformed with avirtual keyboard andtouch interactions onthe screen.

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Image /page/21/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.

Toble 5: Comparison of software (SW) technologics the subject device SOMATOM On.site with software version syngo CT VB00 and the predicted evices.

Software (SW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. ScannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
Operating System	Windows basedSOMARIS/10 syngo CT VB10Note: the short version syngo CTVB10 is also used as labelinginformation	Windows basedSOMARIS/10 syngo CT VA35Note: the short version syngoCT VA35 is also used as labelinginformation	Windows basedSOMARIS/10 syngo CT VB10Note: the short version syngo CTVB10 is also used as labelinginformation	New software version
Workplace	• syngo Acquisition Workplace— Touch UI works asintegrated Image ComputingSystem (ICS) to enable all-in-one concept for mobile CT	• syngo Acquisition Workplace— Touch UI works asintegrated Image ComputingSystem (ICS) to enable all-in-one concept for mobile CT	syngo Acquisition Workplacenamed as "myExam Console"— Gantry-integrated ICS	Same as the primarypredicate device
	• Image reconstruction System(IRS)	• Image reconstruction System(IRS)	• Image reconstruction System(IRS)• 2nd Acquisition Workplacenamed as "myExam Satellite"
Standard systemsoftware	• syngo Examination• syngo Viewing• syngo Filming	• syngo Examination• syngo Viewing• syngo Filming	• syngo Examination• syngo Viewing• syngo Filming	Same as the primarypredicate device
Software (SW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. ScannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
	• syngo Archiving &Networking	• syngo Archiving &Networking	• syngo Archiving &Networking
Detectorfirmware	Stellar detector firmwaresupported	Stellar detector firmwaresupported	Stellar detector firmwaresupported	Same as the primaryand the secondarypredicate device
Protocols	• Examination Protocols forHead and Neck• Protocol supporting contrastbolus-triggered dataacquisition• Adult/ pediatric protocols forhead and neck examination• Protocol overwriteprotection• Administrator privileges forprotocol creation	• Examination Protocols forHead and Neck• Protocol supporting contrastbolus-triggered dataacquisition• Adult/ pediatric protocols forhead and neck examination• Protocol overwriteprotection• Administrator privileges forprotocol creation	• Protocols for RadiationTherapy Planning supportpatient marking• Protocols that allow scanningwith support of an externalrespiratory gating system(ANZAI, Varian RGSC)• Protocol supporting contrastbolus-triggered dataacquisition• Contrast media protocols(including coronary CTA)• Adult protocols• Pediatric protocols• Flex Dose Profile• Dual Energy acquisition(TwinBeam DE andTwinSpiral DE)• Dynamic imaging (Flex 4DSpiral)	Same as the primarypredicate device
Software (SW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. ScannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
			• Protocols supportingIntervention (scan modes: i-sequence, i-spiral, i-Fluoro)• Protocol overwriteprotection• Administrator privileges forprotocol creation• Protocols forDirectBreathhold• Protocols supporting CardiacScanning
Touch UI – usermodes	Touch screen display with twomodes:• Basic User mode (Touch UI)Routine examination workflow,e.g. plan, control, and acquirediagnostic scans.• Advanced mode (AdvancedUI)Contains more advancedfunctionalities, such as qualityassurance, as well asadministration andconfiguration tasks.	Touch screen display with twomodes:• Basic User Mode (Scan&GO)Routine examination workflow,e.g. plan, control, and acquirediagnostic scans.• Advanced mode (AdvancedUI)Contains more advancedfunctionalities, such as qualityassurance, as well asadministration andconfiguration tasks.	Touch screen display onScan&GO mobile tablet:provides mainly supportivefunctions required for planningand controlling scans;not intended to be used forimage acquiring, image storageand image reconstruction.	Same user modes asthe primary predicatedevice
Software (SW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. ScannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
	Connecting or removing scanrangesModifying parameters	Connecting or removing scanrangesModifying parameters
AdvancedReconstruction	Recon&GO:• Inline Anatomical ranges(Parallel/Radial)• Inline table and boneremoval	Recon&GO:no integrated advancedvisualization tools	Recon&GO:• Spectral Recon• Inline Results DE SPP• Inline Anatomical ranges(Parallel/Radial)• Inline Spine and Rib Ranges• Inline table and boneremoval	Compared to theprimary predicatedevice, a subset ofadvancedvisualization tools(Recon&GO - Inlineresults) is nowintegrated within theRecon&GO of thesubject deviceSOMATOM On.sitewith syngo CT VB10.Same as thesecondary predicatedevice thevisualization toolsInline Anatomicalranges(Parallel/Radial) andInline table and boneremoval are nowintegrated within
Software (SW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. ScannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
				Recon&GO of thesubject device.
Image viewing	CT View&GO offers:• basic post-processing viewer(CT View&GO)• 2D and 3D (MPR, VRT, MIPand minIP)• Evaluation tools, Filming,Printing• Basic manipulation tools: ROIHU Threshold, Automatedtable and bone removal	CT View&GO offers:• basic post-processing viewer(CT View&GO)• 2D and 3D (MPR, VRT, MIPand minIP)• Evaluation tools, Filming,Printing	CT View&GO offers:• basic post-processing viewer(CT View&GO)• 2D and 3D (MPR, VRT, MIPand minIP)• Evaluation tools, Filming,Printing• Interactive Spectral Imaging(ISI)• Basic visualization tools:Endo View• Basic manipulation tools: DEROI , ROI HU Threshold,Average, Automated Boneand Table removal	Compared to theprimary predicatedevice, the CTView&GO function ofthe subject deviceSOMATOM On.sitewith syngo CT VB10supports morevisualization andmanipulation tools.Same as thesecondary predicatedevice ROI HUThreshold andAutomated Table andBone removal arenow integrated in thesubject deviceSOMATOM On.sitewith syngo CT VB10
Software (SW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. ScannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
Post-Processinginterface	• Recon&GO Inline Results:Software interface to post-processing algorithms whichare unmodified when loadedonto the CT scanners and510(k) cleared as medicaldevices in their own right.• software interfaces for post-processing functionalities toprovide advancedvisualization tools to prepareand process medical imagesfor diagnostic purpose.Note: The clearance ofstandalone AdvancedVisualization Applicationsoftware is mandatoryprecondition.These advanced visualizationtools are designed to supportthe technician & physician inthe qualitative andquantitative measurement &analysis of clinical dataacquired and reconstructed	• Recon&GO Inline Results:Software interface to post-processing algorithms whichare unmodified when loadedonto the CT scanners and510(k) cleared as medicaldevices in their own right.• software interfaces for post-processing functionalities toprovide advancedvisualization tools to prepareand process medical imagesfor diagnostic purpose.Note: The clearance ofstandalone AdvancedVisualization Applicationsoftware is mandatoryprecondition.These advanced visualizationtools are designed to supportthe technician & physician inthe qualitative andquantitative measurement &analysis of clinical dataacquired and reconstructed	• Recon&GO Inline Results:Software interface to post-processing algorithms whichare unmodified when loadedonto the CT scanners and510(k) cleared as medicaldevices in their own right.• software interfaces for post-processing functionalities toprovide advancedvisualization tools to prepareand process medical imagesfor diagnostic purpose.Note: The clearance ofstandalone AdvancedVisualization Applicationsoftware is mandatoryprecondition.These advanced visualizationtools are designed to supportthe technician & physician inthe qualitative andquantitative measurement &analysis of clinical dataacquired and reconstructed	Same as the primaryand the secondarypredicate device.
Software (SW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. ScannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
	by Computed Tomographyscanners.	by Computed Tomographyscanners.	by Computed Tomographyscanners.
Check&GO	Check&GOQuality check of the imagesbefore sending them to thereading workplace, e.g. PACSCheck&GO – Metal detectiondetects metal objects on or nearthe patient, including objectsrequired for the examination,for example, ECG wires.	Check&GOQuality check of the imagesbefore sending them to thereading workplace, e.g. PACS	Check&GOQuality check of the imagesbefore sending them to thereading workplace, e.g. PACSCheck&GO – Metal detectiondetects metal objects on or nearthe patient, including objectsrequired for the examination,for example, ECG wires.	Same as thesecondary predicatedevice
myExamCompanion -myExamCompass/myExamCockpit	• myExam Compasscollects information about thecurrent patient to dynamicallyadapt the scan parameters orexchange recon jobs accordingto the patient's characteristics• myExam Cockpitoption of displaying, modifying,creating, and deleting ClinicalDecision Trees (CDTs).myExam Compass functionalityoffers the possibility toactivate/deactivate diagnostic	N/A	• myExam Compasscollects information about thecurrent patient to dynamicallyadapt the scan parameters orexchange recon jobs accordingto the patient's characteristics• myExam Cockpitoption of displaying, modifying,creating, and deleting ClinicalDecision Trees (CDTs).myExam Compass functionalityoffers the possibility toactivate/deactivate diagnostic	Same as thesecondary predicatedevice
Software (SW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. ScannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
	scan ranges, Bolus Tracking andTest Bolus ranges. myExamCockpit allows to define thesenew settings.		scan ranges, Bolus Tracking andTest Bolus ranges. myExamCockpit allows to define thesenew settings.
Cybersecurity	IT security functionalitiessupported	IT security functionalitiessupported	IT security functionalitiessupported (IT Hardening)	Same as the primarypredicate device
Teamplay	Support of teamplay protocols	Support of teamplay protocols	Support of teamplay protocols	Same as the primaryand the secondarypredicate device
HD FoV	supported	supported	supported	Same as the primarypredicate device
StandardTechnologies	FAST FeaturesCARE FeaturesGO technology	FAST FeaturesGO technology	FAST FeaturesCARE FeaturesGO technology	Same as thesecondary predicatedevice
Dose modulation	FAST kVCARE Dose 4DX-CARETopogram with Tin FilterTechnology	N/A	FAST kVCARE Dose 4DX-CARETopogram with Tin FilterTechnology	Same as thesecondary predicatedevice
FAST Planning	Selects the body region on thetopogram image that is to bedetected for the recon range	N/A	Selects the body region on thetopogram image that is to bedetected for the recon range	Same as thesecondary predicatedevice
Software (SW)property	Subject deviceSOMATOM On.siteSOMARIS/10 syngo CT VB10	Primary predicate deviceSOMATOM On. ScannersSOMARIS/10 syngo CT VA35(K193277)	Secondary predicate deviceSOMATOM go.UpSOMARIS/10 syngo CT VB10(K233650)	Assessment of thesubstantialequivalency (SE)
IterativeReconstructionMethods	iMARADMIRE	iMARSAFIRE	iMARSAFIRE	With softwareversion VB10, SAFIREis descoped andreplaced by ADMIRE,because of improvedalgorithmperformance.ADMIRE wasoriginally approvedwith K133646 and itis the same as theSOMATOM go.Platform withSOMARIS/10 syngoCT VB10 (K233650).K233650 is a bundle510(k) with variousSiemens CT scannersystems includingSOMATOM go.Up.

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SIEMENS ::•

Healthineers ::•

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Any differences in technological characteristics do not raise different questions of safety and validation is completed. Test results show that the subject device SOMATOM On.site with syngo CT VB10 is comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.

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VIII. Performance Data

Non-Clinical Testing

Non-clinical testing, (integration and functional) including phantom tests were conducted for the SOMATOM On.site 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 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 6 below.

Feature/Non-clinicalsupportive testing	Bench Testing performed
FAST kV	The bench test evaluates the performance of FAST kV.
	The objective of the test is to demonstrate:
	- That image quality (in terms of contrast-to-noise ratio) at thedifferent kV settings offered by the system is consistent whenusing FAST kV.- That radiation dose levels are reduced at 80 kV.
	The test results show:
	- For iodine and calcium contrast material inserts in a cylindrical20 cm water phantom with corresponding FAST kV settings
Feature/Non-clinicalsupportive testing	Bench Testing performed
	'vascular' and 'bone/calcium', CNR values at 80 kV and 120 kV are consistent (deviations well below 15%).
	In comparison to 120 kV, dose levels at 80 kV are slightly reduced (-5%) with the 'bone/calcium' setting and are substantially reduced (-44%) with the 'vascular' setting of FAST kV.
CARE Dose4D	The bench test evaluates the performance of CARE Dose4D in the subject device SOMATOM On.site as compared to the predicate device SOMATOM go.Up.
	The objective of the bench test is to demonstrate:
	comparable performance of CARE Dose4D in SOMATOM On.site and the predicate device SOMATOM go.Up.
	CARE Dose4D leads to reduced dose levels at consistent image quality.
	Phantom-based measurements have been performed on the subject device SOMATOM On.site (intended for head and neck scans) and the predicate device SOMATOM go.Up (whole body diagnostic scanner). The performance of CARE Dose4D is assessed with respect to radiation dose (CTDIvol) and image noise levels (image quality).
	The evaluation showed equivalent performance results for CARE Dose4D in the subject device SOMATOM On.site and the predicate device SOMATOM go.Up. It can be concluded the performance of the CARE Dose4D functionalities is comparable to those of the predicate device SOMATOM go.Up. Consequently, the results and the conclusions of the clinical publications listed in the bench testing are transferable also for the subject device SOMATOM On.site.
	CARE Dose4D is a well-established tube current modulation (TCM) technology, which is offered on Siemens and Siemens Healthineers CT systems since the early 2000s. The bench test document lists various clinical publications that show the dose reduction potential of TCM in general and specifically of CARE Dose4D.
X-CARE	The bench test evaluates the performance of X-CARE in the subject device SOMATOM On.site as compared to the predicate device SOMATOM go.Up.
	The objective of the bench test is to demonstrate:
	comparable performance of X-CARE in SOMATOM On.site and the predicate device SOMATOM go.Up.
	X-CARE leads to reduced dose levels to the eye lenses at consistent image quality.
	Phantom-based measurements have been performed on the subject device SOMATOM On.site (intended for head and neck scans) and the
Feature/Non-clinicalsupportive testing	Bench Testing performed
	predicate device SOMATOM go.Up (whole body diagnostic scanner). Theperformance of X-CARE is assessed with respect to radiation dose(CTDIvol) and image noise levels (image quality).
	The evaluation showed equivalent performance results for X-CARE in thesubject device SOMATOM On.site and the predicate device SOMATOMgo.Up. It can be concluded the performance of the X-CARE functionalityis comparable to those of the predicate device SOMATOM go.Up.Consequently, the results and the conclusions of the clinical publicationslisted in the bench testing are transferable also for the subject deviceSOMATOM On.site.
	X-CARE is a well-established, organ-based tube current modulationtechnology, which is offered on Siemens and Siemens Healthineers CTsystems since the early 2010s. The bench test document lists variousclinical publications that show the organ dose reduction potential of X-CARE.
ADMIRE	The bench test evaluates the characteristics of the iterativereconstruction algorithm ADMIRE on the On.site.
	The objectives of this test are to demonstrate that ADMIRE reducesimage noise at the Somatom On.site CT scanner and maintains a naturalimage impression without noticeable loss of sharpness. The mean CTvalues, and specifically the water value, do not vary when ADMIREreconstruction is used instead of a weighted filtered back-projectionWFBP.
	The test results show:
	The water value and the CT value of the PTFE object remainconstant with increasing ADMIRE strength settings andcompared to the WFBP reconstruction. The sharpness, demonstrated with an edge MTF function of thePTFE object, is constant with increasing ADMIRE strength settingand compared to the WFBP reconstruction. The image noise decreases compared to the WFBP setting andwith increasing ADMIRE strength. Image impression ismaintained as the shape of the noise distribution remainsGaussian with any ADMIRE strength setting.

Table 6: Non-clinical performance testing (bench testing).

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A list of recognized and general consensus standards considered for the subject device is provided as Table 7 and Table 8 below.

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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 inMedicine (DICOM) Set
07/06/2020	12-325	NEMA	XR 25-2019	Computed TomographyDose Check
07/06/2020	12-330	NEMA	XR 28-2018	SupplementalRequirements for UserInformation and SystemFunction Related to Dose inCT
12/23/2019	12-328	IEC	61223-3-5 Edition 2.02019-09	Evaluation and routinetesting in medical imagingdepartments - Part 3-5:Acceptance tests andconstancy tests - Imagingperformance of computedtomography X-rayequipment [Including:Technical Corrigendum 1(2006)]
03/14/2011	12-226	IEC	61223-2-6 SecondEdition 2006-11	Evaluation and routinetesting in medical imagingdepartments - Part 2-6:Constancy tests - Imagingperformance of computedtomography X-rayequipment
07/07/2021	12-336	IEC	60601-1-3 Edition2.2 2021-01CONSOLIDATEDVERSION	Medical electricalequipment - Part 1-3:General requirements forbasic safety and essentialperformance - CollateralStandard: Radiationprotection in diagnostic X-ray equipment
06/27/2016	12-302	IEC	60601-2-44 Edition3.2: 2016	Medical electricalequipment - Part 2-44:Particular requirements forthe basic safety andessential performance of x-
Date ofEntry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
12/23/2019	5-125	ANSI AAMIISO	14971: 2019	ray equipment forcomputed tomography
		ISO	14971 Third Edition2019-12	Medical devices -Applications of riskmanagement to medicaldevices
01/14/2019	13-79	ANSI AAMIIEC	62304:2006/A1:2016	Medical device software -Software life cycleprocesses [IncludingAmendment 1 (2016)]
		IEC	62304 Edition 1.12015-06CONSOLIDATEDVERSION	Medical device software -Software life cycleprocesses
05/30/2022	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 electricalequipment - Part 1: Generalrequirements for basicsafety and essentialperformance (IEC 60601-1:2005, MOD) [IncludingAmendment 2 (2021)]
12/21/2020	19-36	ANSI AAMIIEC	60601-1-2:2014[Including AMD1:2021]	Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances -Requirements and tests
		IEC	60601-1-2 Edition 4.12020-09CONSOLIDATEDVERSION	Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances -Requirements and tests
Date ofEntry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
07/06/2020	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 -Part 1: Equipmentclassification, andrequirements
12/21/2020	5-132	IEC	60601-1-6 Edition 3.22020-07CONSOLIDATEDVERSION	Medical electricalequipment - Part 1-6:General requirements forbasic safety and essentialperformance - Collateralstandard: Usability
12/23/2019	12-309	IEC	60601-2-28 Edition3.0 2017-06	Medical electricalequipment - Part 2-28:Particular requirements forthe basic safety andessential performance of X-ray tube assemblies formedical diagnosis
12/20/2021	12-341	IEC	62563-1 Edition 1.22021-07CONSOLIDATEDVERSION	Medical electricalequipment - Medical imagedisplay systems - Part 1:Evaluation methods

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Table 8: 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]

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StandardDevelopingOrganization	Standard DesignationNumber and Date	Title of Standard	How was Standard Used
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.

A list of applicable guidance documents considered for this submission is provided as Table 9 below.

Table 9: FDA Guidance Document and Effective Date

FDA Guidance Document	Issue date
User Fees and Refunds for Premarket Notification Submissions (510(k)s):Guidance for Industry and Food and Drug Administration Staff	10/05/2022
Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and DrugAdministration Staff	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
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	09/27/2019
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 and Contentof 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 Premarket Submissionsfor Medical Devices	09/14/2018

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Verification and Validation

The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.

Cybersecurity

Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.

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

Verification and validation and phantom testing were performed. The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the subject device SOMATOM On.site performs as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM On.site with the described modifications performs comparably to the predicate devices currently marketed for the same intended use. The conclusion drown from the non-clinical tests demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate devices.

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.