Micro C Medical Imaging System, M01

K212654

OXOS Medical, Inc. · cleared 2022-02-04 · product code IZL · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.4)

“The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The Micro C Medical Imaging System, M01 has custom validated software that includes a user interface that allows the operator to view and adjust captured radiographs and transfer radiographs to a PACS server or flash drive. AiLARA is a static artificial intelligence (AI) based algorithm in the updated software.”

Algorithmstatic artificial intelligence (AI) based algorithm

source quote (p.9)

“AiLARA is a static artificial intelligence (AI) based algorithm in the updated software.”

Adaptive (vs locked)No

source quote (p.9)

“AiLARA is a static artificial intelligence (AI) based algorithm in the updated software.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (6)

Bench

sample size not stated

endpoints: mean squared error; mean absolute error

Bench

sample size not stated

endpoints: system-level software requirements

Bench

sample size not stated

endpoints: diagnostically and clinically relevant image quality

Bench

sample size not stated

endpoints: radiation outputs as compared to diagnostic reference levels; statistical difference between AiLARA and Manual mode calculated entrance skin exposure doses

Bench

sample size not stated

endpoints: radiation outputs for small size extremity anatomies compared to diagnostic reference levels; doses are consistently acceptable

Bench

n=15 other

endpoints: acceptable use-related risks and effectiveness

standards: IEC 62366-1:2020

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

-48%

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).