AI-Rad Companion Prostate MR is indicated for the processing and annotation of DICOM MR prostate images acquired in adult male populations that demonstrate indications of oncological abnormalities in the prostate.

The AI-Rad Companion Prostate MR software aims to support the radiologist and provides the following functionality:
• Viewing, analyzing, evaluating prostate MR images including DCE, ADC, T2 and DWI
• Hosting application for and provides interface to external Prostate MR AI plug-in device
• Accept/reject/edit the results generated by the plug-in software Prostate MR AI

Device Description

AI-Rad Companion Prostate MR is a diagnostic aid in the interpretation of prostate MRI examinations acquired according to the PI-RADS standard.

AI-Rad Companion Prostate MR provides quantitative and qualitative information based on bi or multiparametric prostate MR DICOM images. It displays information on the segmented gland, prostate volume, and segmented lesions along with their classifications. This information can be used to support the reading and reporting of prostate MR studies, as well as the planning of prostate biopsies in the case of ultrasound guided MR-US fusion biopsies of the prostate gland.

The primary features of AI-Rad Companion Prostate MR include:
• Display of Automatic Segmentation and volume of the prostate gland as well as display of automatic segmentation, quantification and classification of lesions
• Manual Adjustment of gland and lesion segmentation and editing of lesion scores, diameter, and localization of the automated generated lesions
• Marking of new lesions
• Export of results as RTSS format for import into supporting ultrasound or fusion biopsy planning systems

AI/ML Overview

Based on the provided FDA 510(k) clearance letter for AI-Rad Companion Prostate MR (K252608), there is no specific study described that proves the device meets predefined acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). The document primarily focuses on demonstrating substantial equivalence to a predicate device (AI-Rad Companion Prostate MR K193283) and adherence to non-clinical verification and validation standards for software development and risk management.

The document explicitly states: "No clinical tests were conducted to test the performance and functionality of the modifications introduced within AI-Rad Companion Prostate MR."

Therefore, a table of acceptance criteria and reported device performance, information about sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details are not available in this document as no clinical performance study for the modified device was performed.

The document emphasizes that modifications and improvements were verified and validated through non-clinical tests (software verification and validation, unit, system, and integration tests), which demonstrated conformity to industry standards and the predicate device's existing safety and effectiveness.

Here’s a breakdown of what is stated in the document regarding testing:

1. A table of acceptance criteria and the reported device performance:

Not provided. The document does not include a table of specific clinical acceptance criteria (e.g., target sensitivity or specificity values) or reported device performance metrics against such criteria. The focus is on demonstrating that software enhancements do not adversely affect safety and effectiveness, assuming the predicate device's performance was already acceptable.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided. Since no clinical performance study was conducted for this specific submission, details on test set sample sizes and data provenance are not presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. As no clinical study is reported, this information is not available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not done. The document explicitly states "No clinical tests were conducted."

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

Not explicitly stated for the modified device. While the device description mentions automatic segmentation and classification, the overall context emphasizes a "diagnostic aid" that "aims to support the radiologist" and has functionality to "Accept/reject/edit the results generated by the plug-in software Prostate MR AI." This suggests an interactive workflow where standalone performance is not the primary claim for this particular submission. The separate product, "Prostate MR AI (K241770)," which performs the core AI tasks, is likely where standalone performance would be detailed, but not in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable for this submission, as no new clinical performance study is detailed for the modified device. The original predicate device's performance would have relied on a ground truth, but that information is not part of this document.

8. The sample size for the training set:

Not provided. Since this submission is for an updated version of an already cleared device and no new clinical performance study is detailed, the training set size for the underlying AI model (likely part of K241770 or the predicate K193283) is not included here.

9. How the ground truth for the training set was established:

Not provided. This information would typically be detailed in the original submission for the AI algorithm (likely K241770 or K193283), not in this update focused on software enhancements and substantial equivalence.

In summary, the provided document focuses on demonstrating that the enhancements and modifications to the AI-Rad Companion Prostate MR do not adversely affect the safety and effectiveness of the existing predicate device. It relies on non-clinical software verification and validation, and substantial equivalence arguments, rather than presenting a de novo clinical performance study with new acceptance criteria and results.

Summary

FDA 510(k) Clearance Letter - AI-Rad Companion Prostate MR

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

Doc ID # 04017.08.01

September 9, 2025

Siemens Healthcare GmbH
℅ Prithul Bom
Most Responsible Party
Regulatory Technology Services, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul, Minnesota 55114

Re: K252608
Trade/Device Name: AI-Rad Companion Prostate MR
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical image management and processing system
Regulatory Class: Class II
Product Code: LLZ
Dated: August 18, 2025
Received: August 18, 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

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K252608 - Prithul Bom Page 2

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

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K252608 - Prithul Bom Page 3

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-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,

Digitally signed by Michael D. O'hara -S
Date: 2025.09.09 10:52:12 -04'00'

Michael D. O'Hara, Ph.D.
Deputy 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K252477

Device Name
AI-Rad Companion Prostate MR

Indications for Use (Describe)
AI-Rad Companion Prostate MR is indicated for the processing and annotation of DICOM MR prostate images acquired in adult male populations that demonstrate indications of oncological abnormalities in the prostate.

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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

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

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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510(k) SUMMARY FOR AI-RAD COMPANION PROSTATE MR K252477

Submitted by:
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Date Prepared: June 5, 2025

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

1. Submitter

Importer/Distributor
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Mail Code: 65-1A
Malvern, PA 19355
Registration Number: 2240869

Manufacturing Site
Siemens Healthcare GmbH
Henkestrasse 127
Erlangen, Germany 91052
Registration Number: 3002808157

2. Contact Person

Kira Morales
Senior Manager Regulatory Affairs
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
Phone: +1 (484) 901-9471
Email: kira.morales@siemens-healthineers.com

3. Device Name and Classification

Product Name: AI-Rad Companion Prostate MR
Trade Name: AI-Rad Companion Prostate MR
Common Name: System, Image Processing, Radiological

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Classification Name: Medical Image Management and Processing System
Classification Panel: Radiology
CFR Section: 21 CFR §892.2050
Device Class: Class II
Product Code: LLZ

4. Predicate Device

Product Name: AI-Rad Companion Prostate MR
510(k) Number: K193283
Clearance Date: July 30, 2020
Classification Name: Automated Radiological Image Processing Software
Classification Panel: Radiology
CFR Section: 21 CFR §892.2050
Device Class: Class II
Primary Product Code: QIH
Secondary Product Code: LNH

5. Intended Use

6. Device Description

AI-Rad Companion Prostate MR is a diagnostic aid in the interpretation of prostate MRI examinations acquired according to the PI-RADS standard.

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• Manual Adjustment of gland and lesion segmentation and editing of lesion scores, diameter, and localization of the automated generated lesions

• Marking of new lesions

• Export of results as RTSS format for import into supporting ultrasound or fusion biopsy planning systems

As key benefits for the radiologist, AI-Rad Companion Prostate MR is designed to deliver performance improvements in reading and reporting prostate MRI according to the PI-RADS standard.

7. Substantially Equivalent (SE) & Technological Characteristics

The subject device, AI-Rad Companion Prostate MR is substantially equivalent to the predicate device with regards to software, programming languages, operating system, performance and fundamental technology. AI-Rad Companion Prostate MR offers enhancements and improvements to the existing predicate device, AI-Rad Companion Prostate MR (K193283). While these enhancements and improvements offer additional image viewing and evaluation capabilities compared to the predicate device, the conclusions from all verification and validation data suggest that these modifications do not adversely affect the safety and effectiveness of the subject device.

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A tabular comparison of the subject device is provided in Table 1 below.

Feature	Subject: AI-Rad Companion Prostate MR VA60	Predicate: AI-Rad Companion Prostate MR VA20 (K193283)	Comparison Results
Product Classification	Primary Classification Product Code: LLZ Regulation Number: 892.2050	Primary Classification Product Code: QIH Regulation Number: 892.2050 Secondary Classification Product Code: LNH	Equivalent – The regulation number remains unchanged. The AI algorithm has been separated into its own product (Prostate MR AI (K241770).
Segmentation Algorithm	Automatic segmentation of the prostate gland is completed by Prostate MR AI (K241770)	Automatic segmentation of the prostate gland based on transversal T2-weighted morphological images with the possibility of manual adjustments.	Modified – The automatic segmentation of the prostate gland is contained within Prostate MR AI (K241770) and is not in scope of this submission.
Target Population	Adult males (40 years and older) with a prostate gland undergoing screening or clinical MRI exams. This includes populations that demonstrate suspicion of oncological abnormalities in the prostate as determined by clinical experts or with family history of prostate cancer.	AI-Rad Companion Prostate MR is intended for use only on data from the following populations: • Adults (>18 years) Populations that demonstrate suspicion of oncological abnormalities in the prostate as determined by a clinical expert	Modified – The target population has been aligned with the clinically relevant population
Environment of use	Clinical/Hospital environment	Clinical/Hospital environment	Unchanged
Contraindications	There are no known contraindications for use of this device.	There are no known contraindications for use of this device.	Unchanged
Software Architecture	AI-Rad Companion (Engine) architecture enabling the deployment of	AI-Rad Companion (Engine) architecture enabling the deployment of	Enhanced – AI-Rad Companion has added

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Feature	Subject: AI-Rad Companion Prostate MR VA60	Predicate: AI-Rad Companion Prostate MR VA20 (K193283)	Comparison Results
	AI Rad Companion Prostate MR in the Cloud and through Edge deployment. The UI is provided using a web-based interface.	AI Rad Companion Prostate MR in the Cloud. The UI is provided using a web-based interface.	Edge deployment. The addition of the edge deployment does not change the intended use or core functionality, it enhanced deployment flexibility
Use Scenarios	• Manual adjustment of the automatically performed gland and lesion segmentations • Editing of lesion scores, diameter, localization of the automated generated lesions • Marking of new lesions and deletion of lesion marks • Determination of the PSA density by entering the PSA value of the patient • Computation of Global PI-RADS score	• Manual adjustment of the automatically performed prostate segmentation • Manual annotation of lesions • Obtaining PSA density of the patient by entering the PSA value of the patient	Enhanced – The expanded use scenarios is a result of the addition of the lesion detection and PI-RAD scoring from Prostate MR AI (K241770).
Workflow	• Semi-automatic workflow • Automatic workflow	• Semi-automatic workflow	Enhanced – Introduction of the automatic workflow option which enables the user to automatically send results to PACS without using the Confirmation UI. However, results must be accepted by the user in the PACS.

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Feature	Subject: AI-Rad Companion Prostate MR VA60	Predicate: AI-Rad Companion Prostate MR VA20 (K193283)	Comparison Results
Distribution and Archiving	• Export of the results as "burnt-in" contours in DICOM MR images and as RTSS format that can be imported into supporting ultrasound or fusion biopsy planning systems, allowing the urologist to perform targeted MR-US fusion biopsy. • A summary of the numeric results (gland volume, PSA value, PSA density, localization, diameter, and score of lesions) is provided as well in the form of a DICOM Secondary Capture object • The results are also exported in additional formats like DICOM Structured Report and DICOM GSPS.	• Export of the contours in a suitable format for reading and archiving in PACS, as well as in a second format (RTStruct) that can be imported into ultrasound systems, allowing the urologist to perform targeted MR-US fusion biopsy	Enhanced- • "Burnt-in contours enhance visualization but do not alter clinical output • The summary of numeric results was provided in the predicate however now it can be exported as a DICOM secondary capture object • DICOM structured report and DICOM GSPS are standard formats
User Roles	• Radiologist • Clinical IT Administrator	• Radiologist • Clinical IT Administrator	Unchanged

Table 1: Predicate Device Comparison Table

The conclusions from all verification and validation data suggests that these enhancements are equivalent with respect to safety and effectiveness of the predicate device. These modifications do not change the intended use of the product. Siemens is of opinion that AI-Rad Companion Prostate MR VA60 is substantially equivalent to the currently marketed device, AI-Rad Companion Prostate MR (K193283).

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8. Nonclinical Tests

Software verification and validation have been conducted to assess the performance claims as well as the claim of substantial equivalence to the predicate device. AI-Rad Companion Prostate MR has been tested to meet the requirements of conformity to multiple industry standards. Non-clinical performance testing demonstrated that AI-Rad Companion Prostate MR complies with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Device Software Functions" (June 2023) as well as with the following voluntary FDA recognized Consensus Standards listed in Table 2.

Recognition Number	Product Area	Title of Standard	Reference Number and Date	Standards Development Organization
5-125	General	Medical devices – Application of risk management to medical devices	14971 Third Edition 2019-12	ISO
13-79	Software/Informatics	Medical device software – software life cycle processes [Including Amendment 1 (2016)]	62304 Ed 1.1 2015-06 CV	AAMI ANSI IEC
5-129	General	Medical Devices – Application of usability engineering to medical devices	62366-1 Ed 1.1 2020-06 CV	IEC
5-134	General	Medical devices – symbols to be used with information to be supplied by the manufacturer – Part 1: General Requirements	15223-1 Fourth edition 2021-07	ISO IEC
13-97	Software/Informatics	Health software – Part 1: General requirements for product safety	82304-1 Edition 1.0 2016-10	IEC
5-135	General	Medical devices – Information to be supplied by the manufacturer	20417 First edition 2021-04	ISO
12-352	Radiology	Digital Imaging and Communications in Medicine (DICOM) Set	PS 3.1 – 3.20 2023e	NEMA

Table 2: Voluntary Conformance Standards

Verification and Validation

Software testing in the form of Unit, System and Integration tests were performed to evaluate the performance and functionality of the new features and software updates. All testable requirements in the Requirement Specifications and the Risk Analysis have been successfully verified and traced in accordance with the Siemens Healthineers DH product development

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(lifecycle) process. Human factor usability validation is addressed in system testing and usability validation test records. Software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.

Siemens Healthineers adheres to the cybersecurity requirements as defined the FDA Guidance "Content of Premarket Submissions for Management for Cybersecurity in Medical Devices," issued September 27, 2023 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.

9. Clinical Tests

No clinical tests were conducted to test the performance and functionality of the modifications introduced within AI-Rad Companion Prostate MR. Verification and validation of the enhancements and improvements have been performed and these modifications have been validated for their intended use. The data from these activities were used to support the subject device and the substantial equivalence argument.

No animal testing has been performed on the subject device.

10. Safety and Effectiveness

The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device.

Risk management is ensured via ISO 14971:2007 compliance to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized during software development, testing and product labeling.

Furthermore, the device is intended for healthcare professionals familiar with the post processing of magnetic resonance images.

11. Substantial Equivalence and Conclusion

AI-Rad Companion Prostate MR version VA60 is substantially equivalent to the follow predicate device (Table3):

Predicate Device	FDA Clearance Number	FDA Clearance Date	Main Product Code
AI-Rad Companion Prostate MR VA20	K193283	July 30, 2020	QIH

Table 3: Predicate device for AI-Rad Companion Prostate MR

AI-Rad Companion Prostate MR has an equivalent intended use and basic technical characteristics compared to the predicate device, AI-Rad Companion Prostate MR VA20 (K193283), with respect to the software features and functionalities. While AI-Rad Companion Prostate MR offers enhancements and improvements to the already cleared basic MR workflow and applications, the conclusions from all verification and validation data suggest that the

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modifications do not adversely impact the safety and effectiveness of the subject device. The modifications and improvements enhance the user's workflow and reduce the complexity of certain MR imaging procedures. Siemens is of the opinion that AI-Rad Companion Prostate MR is substantially equivalent to the currently marketed device AI-Rad Companion Prostate MR VA20 (K193283).

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).