AI-Rad Companion Brain MR

K213706

Siemens Healthcare GmBh · cleared 2022-04-15 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“AI-Rad Companion Brain MR is a post-processing image analysis software that assists clinicians in viewing, analyzing, and evaluating MR brain images.”
Algorithmsegmentation and quantitative analysis of individual brain structures and white matter hyperintensities
source quote (p.3)
“AI-Rad Companion Brain MR provides the following functionalities: Automatic segmentation and quantitative analysis of individual brain structures and white matter hyperintensities”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.10)
“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 (2)

Retrospective clinical

n=89 patients · 7 site(s)

endpoints: PCC; ICC; Dice score; F1-score

standards: ISO 14971:2019

Bench

n=25 patients

endpoints: Dice score

standards: ISO 14971:2019

Reported performance (4 observations)

agreement_kappaas written: “ICC (Volumetric Segmentation)”0.97CI [0.96,0.98]
source quote (p.11)
“AVG 0.97 95% CI [0.96,0.98]”
diceas written: “Dice (Voxel-wise Segmentation)”0.6CI [0.53,0.63]
source quote (p.11)
“AVG 0.60 95% CI [0.53,0.63]”
f1as written: “F1-score (WMH Lesion-wise Segmentation)”0.6CI [0.57,0.64]
source quote (p.11)
“AVG 0.60 95% CI [0.57,0.64]”
diceas written: “Dice (Reproducibility)”0.79CI [0.77,0.81]
source quote (p.11)
“AVG 0.79 95% CI [0.77,0.81]”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253057 (decision 2026-01-22) from Siemens Healthcare GmbH for a matching device line ("AI-Rad Companion Brain MR") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253057

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/K213706