AI-Rad Companion Brain MR

K253057

Siemens Healthcare GmbH · cleared 2026-01-22 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Al-Rad Companion Brain MR is a post-processing image analysis software that assists clinicians in viewing, analyzing, and evaluating MR brain images.”

Algorithmruns two distinct and independent algorithms for Brain Morphometry analysis and White Matter Hyperintensities (WMH) segmentation, respectively

source quote (p.7)

“AI-Rad Companion Brain MR runs two distinct and independent algorithms for Brain Morphometry analysis and White Matter Hyperintensities (WMH) segmentation, respectively.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedYes

source quote (p.14)

“Siemens Healthineers adheres to the cybersecurity recommendations as defined the FDA Guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (September 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.”

Validation studies (2)

Standalone

n=100 patients

endpoints: Pearson correlation coefficient; interclass correlation coefficient; Dice score; F1-score

standards: IEC 62366-1, ISO 14971, IEC 62304, PS 3.1 – 3.20, 15223-1, 82304-1

Standalone

n=165 patients

endpoints: Pearson correlation coefficient; Dice score; F1-score

standards: IEC 62366-1, ISO 14971, IEC 62304, PS 3.1 – 3.20, 15223-1, 82304-1

Reported performance (4 observations)

diceas written: “Dice score (WMH segmentation)”0.6CI [0.57, 0.63]

source quote (p.14)

“The segmentation accuracy of the WMH reaches a Dice score of 0.60.”

f1as written: “F1-score (WMH detection)”0.67

source quote (p.14)

“The F1-score of WMH detection is 0.67.”

diceas written: “average Dice score (new or enlarged WMH segmentation)”0.59

source quote (p.15)

“The segmentation accuracy of the new or enlarged WMH reaches an average Dice score of 0.59.”

f1as written: “average F1-score (new or enlarged WMH detection)”0.71

source quote (p.15)

“The average F1-score of new or enlarged WMH detection is 0.71.”

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).