AI-Rad Companion Prostate MR

K193283

Siemens Medical Solutions USA Inc. · cleared 2020-07-30 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“AI-Rad Companion Prostate MR is a cloud-based image processing software that provides quantitative and qualitative information based on prostate MR DICOM images. More specifically, it provides information on the prostate volume which can be used to support the planning of prostate biopsies in the case of ultrasound guided MR-US fusion biopsies of the prostate gland. It is enabled via artificial intelligence algorithms and a cloud infrastructure.”

Algorithmartificial intelligence algorithms

source quote (p.6)

“It is enabled via artificial intelligence algorithms and a cloud infrastructure.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedYes

source quote (p.9)

“Siemens Healthineers adheres to the cybersecurity requirements as defined the FDA Guidance "Content of Premarket Submissions for Management for Cybersecurity in Medical Devices," issued October 2, 2014 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.”

Validation studies (1)

Bench

sample size not stated

standards: IEC 62366-1:2015-02, ISO 14971:2007, AAMI/ANSI/IEC 62304:2006/A1:2016, NEMA PS 3.1-3.20 (2016), ISO/IEC 10918-1 1994-02-15

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).