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Prostate MR AI (VA10A)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241770

by Siemens Healthcare GmbH

Identifiers

510(k) Number
K241770 FDA 510(k)
FDA Product Code
QDQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2090 FDA 510(k)
Regulation Number
892.2090 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Prostate MR AI (VA10A) is a radiological computer-assisted detection and diagnosis software designed for multiparametric MRI of the prostate. It employs deep neural networks to segment and classify prostate lesions, aiding radiologists in identifying suspicious areas for potential cancer.

This software is intended for use in radiology settings and is supplied as a standalone AI tool. It requires integration with MRI systems and is not classified as single-use or reusable. The device holds FDA 510(k) clearance (K241770) under the Radiology advisory committee, with a classification of Class II (QDQ). No sterility or MRI safety specifications are stated in the data.

Frequently asked questions

What types of MRI systems is the Prostate MR AI (VA10A) designed to integrate with, and how does it assist radiologists in their workflow?

The Prostate MR AI (VA10A) is a standalone AI software tool intended for use with multiparametric MRI systems. It employs deep neural networks to analyze MRI images of the prostate, automatically segmenting and classifying lesions to highlight suspicious areas that may indicate potential cancer. This assists radiologists by streamlining the detection process and drawing attention to regions that require closer examination, thereby improving diagnostic efficiency in radiology settings.

Is the Prostate MR AI (VA10A) a single-use or reusable device, and what are its storage requirements?

The Prostate MR AI (VA10A) is not classified as single-use or reusable, as it is a software-based tool designed for repeated use in radiology environments. Since it is a digital solution, no physical storage requirements like shelf life or environmental conditions apply. However, it must be installed and maintained on compatible MRI systems and may require periodic software updates or system maintenance to ensure optimal performance.

How is the Prostate MR AI (VA10A) regulated, and what does its FDA clearance status mean for users?

The Prostate MR AI (VA10A) holds FDA 510(k) clearance (K241770) under the Radiology advisory committee, classified as a Class II device with the product code QDQ. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, meaning it meets the regulatory standards for safety and effectiveness as established by the FDA. Users can rely on this clearance as a marker of regulatory review, though they should always follow the manufacturer’s instructions for proper use and integration.

Does the Prostate MR AI (VA10A) require any special handling or safety considerations when used with MRI systems?

The provided data does not specify any sterility or MRI safety specifications for the Prostate MR AI (VA10A), as it is a software-based tool rather than a physical device. However, since it is designed for integration with MRI systems, users should ensure compatibility with their specific MRI equipment and follow the manufacturer’s guidelines for installation, operation, and maintenance. No special handling related to sterility is required, as the software itself does not come into direct contact with patients or sterile environments.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Siemens Healthcare GmbH: Prostate MR AI (VA10A) (FDA-cleared AI medical ..., MR Prostate - AI-based segmentation and classification, Prostate MR AI (VA10A) (K241770) — FDA 510 (k) | Innolitics, Prostate MR AI (VA10A) Review: Pricing, FDA Status & Alternatives ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Siemens Healthcare GmbH

Sources (1)

  • FDA 510(k) K241770 24 fields · synced Oct 6, 2026