MediAI-BA
K250914Crescom Co., Ltd. · cleared 2025-12-18 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.7)
“The MediAI-BA and the predicate device EFAI BAPXR (K234042) are both AI-based automated radiological image processing software designed to assist pediatric radiologists in bone age assessment using 2D Posterior-Anterior (PA) X-ray images of the left hand and wrist.”
source quote (p.5)
“This AI-based software utilizes an internal algorithm that integrates global skeletal maturity features extracted from the whole hand radiograph with local skeletal maturity features derived from key Regions of Interest (ROIs).”
Validation studies (2)
Standalone
n=600 cases · 5 site(s)
endpoints: Deming regression analysis; Bland–Altman analysis; frequency distribution (histogram) of differences between MediAI-BA bone age measurements and the reference standard
standards: DICOM
Bench
n=30 cases
endpoints: Consistency tests; Accuracy tests
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
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).