AI-Rad Companion Brain MR
K213706Siemens Healthcare GmBh · cleared 2022-04-15 · product code QIH · Radiology
Premarket evidence — what FDA accepted
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.”
source quote (p.10)
“To validate the AI-Rad Companion Brain MR software from clinical perspective, the white matter hyperintensities segmentation and analysis algorithm underwent a scientific evaluation.”
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 (3)
Bench
sample size not stated
endpoints: test the functionality of AI-Rad Companion Brain MR; assess the performance claims; assess the claim of substantial equivalence to the predicate device
Retrospective clinical
n=64 patients · 7 site(s)
endpoints: PCC 95% Confidence Interval includes 0.91; ICC 95% Confidence Interval includes 0.95; Mean Dice score >= 0.58; Mean F1-score >= 0.57
Retrospective clinical
n=25 patients · 7 site(s)
endpoints: Lower Bound of the 95% Bootstrap CI Dice >= 0.63
Reported performance (4 observations)
source quote (p.11)
“AVG 0.97 95% CI [0.96,0.98]”
source quote (p.11)
“AVG 0.60 95% CI [0.53,0.63]”
source quote (p.11)
“AVG 0.60 95% CI [0.57,0.64]”
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
- 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). 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).