syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra.

Device Description

syngo.MR Applications is a software only Medical Device consisting post-processing applications/workflows used for viewing and evaluating the designated images provided by a MR diagnostic device. The post-processing applications/workflows are integrated with the hosting application syngo.via, that enables structured evaluation of the corresponding images

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for syngo.MR Applications (VB80) indicate that no clinical studies or bench testing were performed to establish new performance criteria or demonstrate meeting previously established acceptance criteria. The submission focuses on software changes and enhancements from a predicate device (syngo.MR Applications VB40).

Therefore, based solely on the provided document, I cannot create the requested tables and information because the document explicitly states:

"No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device."
"No bench testing was required to be carried out for the product."

The document details the following regarding performance and acceptance:

Non-clinical Performance Testing: "Non-clinical tests were conducted for the subject device during product development. The modifications described in this Premarket Notification were supported with verification and validation testing."
Software Verification and Validation: "The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device Syngo.MR Applications during product development... The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence."
Conclusion: "The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use."

This implies that the acceptance criteria are related to the functional specifications and performance of the software, as demonstrated by internal verification and validation activities, rather than a clinical performance study with specific quantitative metrics. The new component, "MR Prostate AI," is noted to be integrated without modification and had its own prior 510(k) clearance (K241770), suggesting its performance was established in that separate submission.

Without access to the actual verification and validation reports mentioned in the document, it's impossible to list precise acceptance criteria or detailed study results. The provided text only states that "all the software specifications have met the acceptance criteria."

Therefore, I can only provide an explanation of why the requested details cannot be extracted from this document:

Explanation Regarding Acceptance Criteria and Study Data:

The provided FDA 510(k) clearance letter and summary for syngo.MR Applications (VB80) explicitly state that no clinical studies or bench testing were performed for this submission. The device (syngo.MR Applications VB80) is presented as a new version of a predicate device (syngo.MR Applications VB40) with added features and enhancements, notably the integration of an existing AI algorithm, "Prostate MR AI VA10A (K241770)," which was cleared under a separate 510(k).

The basis for clearance is "non-clinical performance data" and "software validation data" demonstrating that the subject device performs comparably to and is as safe and effective as the predicate device. The document mentions that "all the software specifications have met the acceptance criteria" as part of the verification and validation (V&V) activities. However, the specific quantitative acceptance criteria, detailed performance metrics, sample sizes, ground truth establishment, or expert involvement for these V&V activities are not included in this public summary.

Therefore, the requested information cannot be precisely extracted from the provided text.

Summary of Information Available (and Not Available) from the Document:

Information Requested	Status (Based on provided document)
1. Table of acceptance criteria and reported performance	Not provided in the document. The document states: "The testing results support that all the software specifications have met the acceptance criteria." However, it does not specify what those acceptance criteria are or report detailed performance metrics against them. These would typically be found in the detailed V&V reports, which are not part of this summary.
2. Sample size and data provenance for test set	Not provided. The document indicates "non-clinical tests were conducted as part of verification and validation activities." The sample sizes for these internal tests, the nature of the data, and its provenance (e.g., country, retrospective/prospective) are not detailed. It is implied that the data is not patient-specific clinical test data.
3. Number of experts and qualifications for ground truth	Not applicable/Not provided. Since no clinical studies or specific performance evaluations against an external ground truth are described in this document, there's no mention of experts establishing ground truth for a test set. The validation appears to be against software specifications. If the "MR Prostate AI" component had such a study, those details would be in its individual 510(k) (K241770), not this submission.
4. Adjudication method for test set	Not applicable/Not provided. As with the ground truth establishment, no adjudication method is mentioned because no external test set requiring such expert consensus is described within this 510(k) summary.
5. MRMC comparative effectiveness study and effect size	Not performed for this submission. The document explicitly states "No clinical studies were carried out for the product." Therefore, no MRMC study or AI-assisted improvement effect size is reported here.
6. Standalone (algorithm only) performance study	Partially addressed for a component. While this submission doesn't detail such a study, it notes that the "MR Prostate AI" algorithm is integrated without modification and "is classified under a different regulation in its 510(K) and this is out-of-scope from the current submission." This implies that a standalone performance study was done for the Prostate MR AI algorithm under its own 510(k) (K241770), but those details are not within this document. For the overall syngo.MR Applications (VB80) product, no standalone study is described.
7. Type of ground truth used	Not provided for the overall device's V&V. The V&V activities are stated to have met "software specifications," which suggests an internal, design-based ground truth rather than clinical ground truth like pathology or outcomes data. For the integrated "MR Prostate AI" algorithm, clinical ground truth would have been established for its separate 510(k) submission.
8. Sample size for the training set	Not applicable/Not provided for this submission. The document describes internal non-clinical V&V for the syngo.MR Applications software. It does not refer to a machine learning model's training set within this context. The "Prostate MR AI" algorithm, being independently cleared, would have its training set details in its specific 510(k) dossier (K241770), not here.
9. How the ground truth for the training set was established	Not applicable/Not provided for this submission. As above, this document does not discuss a training set or its ground truth establishment for syngo.MR Applications. This information would pertain to the Prostate MR AI algorithm and be found in its own 510(k).

Summary

FDA 510(k) Clearance Letter - syngo.MR Applications (VB80)

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.00

November 20, 2025

Siemens Healthineers AG
℅ Prithul Bom
Most Responsible Person
Regulatory Technology Services, LLC
1000 Westgate Drive, Suite 510k
Saint Paul, Minnesota 55114

Re: K253495
Trade/Device Name: syngo.MR Applications (VB80)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical image management and processing system
Regulatory Class: Class II
Product Code: LLZ, LNH
Dated: October 28, 2025
Received: October 28, 2025

Dear Prithul Bom:

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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K253495 - Prithul Bom Page 2

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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K253495 - Prithul Bom Page 3

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,

Daniel M. Krainak, Ph.D.
Assistant Director
DHT8C: Division of Radiological Imaging
and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

Indications for Use

K253495

Please provide the device trade name(s).
syngo.MR Applications (VB80)

Please provide your Indications for Use below.
syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra.

Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

syngo.MR Applications Page 8 of 27

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510(k) Summary

November 19, 2025
K253495

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

1. Submitter:

Siemens Healthineers AG
Siemensstrasse 1
91301 Forchheim
Germany

2. Contact Person:

Mr. Vijay Ramadas
Regulatory Affairs Manager
Siemens Healthineers AG
Siemensstr. 3
91301 Forchheim
Germany

E-mail: vijay.ramadas@siemens-healthineers.com
Telephone: +49 (172) 4324369
Fax: +49 (9191) 18-4404

3. Device Name and Classification

Device/Trade Name: syngo.MR Applications (VB80)
Classification Panel: Radiology Devices
Classification Number: 21 CFR 892.2050
Common Name: System, Image Processing, Radiological
Classification Name: Medical Image Management and Processing System
Device Class: Class II
Product Code: LLZ
Secondary Product Code(s): LNH

4. Predicate Device(s):

Manufacturer	Predicate Device	510(k)
Siemens Healthineers AG	syngo.MR Applications VB40	K192462

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©Siemens Healthineers AG, 2025
Page -2 510(k) for Syngo.MR Applications

5. Device Description:

6. Intended/Indications for use:

syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra.

7. Technological Characteristics:

The device syngo.MR Applications provides the below listed workflows.

• MR General
syngo.MR General is a post-processing application for routine and advanced MR radiology usage. It supports basic routine MR reading and includes additional workflows for dedicated MR examinations that load and structure examination results automatically into meaningful layouts. syngo.MR General contains several MR Radiology workflows, Cardio-Vascular workflows and MR specific Evaluation features.

• MR BreVis
syngo.MR BreVis is a post-processing software package for digital imaging that enables the skilled physician to perform real-time image analysis of dynamic MR datasets. Its purpose is to provide different reading and reporting capabilities to support the tumor diagnostic process for soft tissue.

• MR Cardiology
syngo.MR Cardiology is a post-processing software application intended for viewing and analyzing cardiac magnetic resonance imaging (MRI) studies.

• MR Neurology
syngo.MR Neurology is a post-processing software package, supporting convenient post-processing and reading of dynamic susceptibility contrast (DSC) perfusion MR imaging datasets.

• MR Oncology
syngo.MR Oncology is a post-processing application, supporting convenient reading of MR scans of either multiple body regions or the entire body which have been acquired for clinical purposes such as oncological screening, staging, and grading.

• MR Spectroscopy
syngo.MR Spectroscopy is used to determine the relative concentration of specific metabolites in the examined tissue of an MR spectroscopy scan.

• MR Vascular
syngo.MR Vascular is a post-processing software application intended for viewing and analyzing magnetic resonance imaging (MRI) studies.

• MR Prostate AI
Syngo.MR Prostate AI allows the user to read images of the prostate. With the lesion detection function, potential lesions can be segmented automatically.

Note: The subject device integrates the AI based Algorithm "Prostate MR AI VA10A (K241770)" without any modification. The algorithm is classified under a different regulation in its 510(K) and this is out-of-scope from the current submission of the subject device.

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8. Summary of Differences between the Subject Device and the Predicate Device:

The differences between the subject device described in this premarket notification and the predicate device are summarized in the following comparison table:

Specification	Subject Device	Predicate Device	Comparison
Device name and version	syngo.MR Applications (VB80)	syngo.MR Applications (VB40) K192462	New version of the predicate device with added features and enhancements
Product Classification	Product Code: LLZ Regulation Number: 892.2050	Product Code: LLZ Regulation Number: 892.2050	Same – The AI Algorithm "Prostate MR AI (K241770)" is developed as a stand-alone product and has its own development life cycle. It has its own classification, and it is not in scope of this submission
Indications for use	syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra	syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra	Same
Contraindications	syngo.MR is not to be used as a long term archiving device for patients' image data syngo.MR is not to be used as a sole basis for clinical decisions	syngo.MR is not to be used as a long term archiving device for patients' image data. syngo.MR is not to be used as a sole basis for clinical decisions.	Same
Software architecture	syngo.MR Applications has architecture that is based on a layered pattern where the various workflows are structured to provide their individual functionalities.	syngo.MR Applications has architecture that is based on a layered pattern where the various workflows are structured to provide their individual functionalities.	Same

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Specification	Subject Device	Predicate Device	Comparison
Workflows	There are eight workflows. Each workflow functions independently with the same principle. It comprises of the following components: • syngo.MR General • syngo.MR Neurology • syngo.MR Cardiology • syngo.MR Oncology • syngo.MR Spectroscopy • syngo.MR Vascular • syngo.MR BreVis • syngo.MR Prostate AI	There are Seven workflows. Each workflow functions independently with the same principle. It comprises of the following components: • syngo.MR General • syngo.MR Neurology • syngo.MR Cardiology • syngo.MR Oncology • syngo.MR Spectroscopy • syngo.MR Vascular • syngo.MR BreVis	The new workflow MR Prostate AI enables the user to read Prostate images and detect lesions. The Minor enhancements were made to the existing workflows. - Findings assistant in MR Cardiology - Brain Morphometry in MR Neurology Common to all workflows - Common UI - Motion correction - ADC & b -value
Operating system	None Relies on the hosting application (syngo.via) for operating system.	None Relies on the hosting application (syngo.via) for operating system	Same
Clinical condition the device is intended to diagnose, treat, or manage	No limitation on the clinical condition of the patient	No limitation on the clinical condition of the patient	Same
Intended patient population	No limitation concerning the patient population (e.g., age, weight, health, condition)	No limitation concerning the patient population (e.g., age, weight, health, condition)	Same

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Specification	Subject Device	Predicate Device	Comparison
Site of the body the device is intended to be used	No limitation concerning region of body or tissue type	No limitation concerning region of body or tissue type	Same
Intended user(s)	Trained healthcare professionals	Trained healthcare professionals	Same
Device Type	Software application	Software application	Same

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9. Clinical Testing

No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device

10. Bench Testing Evaluation Summary

No bench testing was required to be carried out for the product

11. Non-clinical Performance Testing:

Non-clinical tests were conducted for the subject device during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

Siemens Healthcare GmbH claims conformance to the following standards:

ISO 14971 Third Edition 2019-12
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
IEC 82304-1 Edition 1.0 2016-10
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION

12. Software Verification and Validation:

Software documentation level of "Basic Documentation" per FDA's Guidance Document "Content of Premarket Submissions for Device Software Functions" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device Syngo.MR Applications during product development.

The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

Siemens Healthcare GmbH 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. Contained in this submission are our cybersecurity considerations as they relate to the device Syngo.MR Applications.

13. Safety and Effectiveness Information:

Software specifications, design descriptions, hazard analysis, and labeling information are submitted in support of this premarket notification. The device labeling contains instructions for use with cautions to provide for safe and effective use of the device.

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14. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use.

In summary, we are of the opinion that the subject device Syngo.MR Applications, software version VB80, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device Syngo.MR Applications VB40.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).