MediAI-BA

K250914

Crescom Co., Ltd. · cleared 2025-12-18 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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).”
AlgorithmAI-based software utilizing 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) to determine bone age. It employs deep learning algorithms.
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). By synthesizing these skeletal maturity features, the software determines the accurate final bone age. Both devices employ deep learning algorithms to analyze input images and generate bone age estimates.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=600 cases · 5 site(s)

endpoints: Deming regression analysis; Bland-Altman analysis; Frequency distribution (histogram) of differences; Consistency tests (SSIM); Accuracy tests (bone age changes when heatmap region masked)

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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/K250914