PeekMed web

K252856

Peek Health, S.A. · cleared 2025-12-22 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“Being software, it does not interact with any part of the body of the user and/or patient.”

AlgorithmML models

source quote (p.7)

“Compared to the predicate device, the subject device includes updates to existing ML variants and the introduction of new ML variants, such as the segmentation and landmarking for the knee region.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Standalone

sample size not stated

endpoints: DICE; HD-95; STD DICE; Precision; Recall; MRE; STD MRE; Accuracy; F1 score; MAP

Bench

sample size not stated

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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).