AI-Rad Companion Brain MR

K232305

Siemens Medical Solutions U.S.A. · cleared 2023-10-23 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“AI-Rad Companion Brain MR is a post-processing image analysis software that assists clinicians in viewing, analyzing, and evaluating MR brain images.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.14)
“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)

Retrospective clinical

n=75 patients · 4 site(s)

endpoints: Volumetric Segmentation Accuracy; Voxel-wise Segmentation Accuracy; WMH Change Region-wise Segmentation Accuracy

standards: IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, ISO 14971 Third Edition 2019-12, IEC 62304 Edition 1.1 2015-06, PS 3.1-3.20 2021e, 15223-1 Fourth edition 2021-07, 82304-1 Edition 1.0 2016-10

Reported performance (2 observations)

diceas written: “Dice (Voxel-wise Segmentation)”0.5CI [0.42,0.57]
source quote (p.16)
“Dice AVG 0.50 95% CI [0.42,0.57]”
f1as written: “F1-score (WMH Lesion-wise Segmentation)”0.69CI [0.633,0.733]
source quote (p.16)
“F1-score AVG 0.69 95% CI [0.633,0.733]”

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K232305