AI-Rad Companion Brain MR
K232305Siemens Medical Solutions U.S.A. · cleared 2023-10-23 · product code QIH · Radiology
Premarket evidence — what FDA accepted
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.”
source quote (p.7)
“Companion Brain MR addresses the automatic quantification and visual assessment of the volumetric properties of various brain structures based on T1 MPRAGE datasets.”
source quote (p.15)
“Brain morphometry follow-up consists of atrophy rate calculation Morphometry follow-up does not include any machine learning or deep learning component therefore it is verified by V&V testing, and no additional evaluation is provided in this document.”
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 (2)
Bench
sample size not stated
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
Retrospective clinical
n=75 patients · 4 site(s)
endpoints: Volumetric Segmentation Accuracy; Voxel-wise Segmentation Accuracy; WMH Change Region-wise Segmentation Accuracy
Reported performance (2 observations)
source quote (p.16)
“Dice AVG 0.50 95% CI [0.42,0.57]”
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
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).