Micro C Medical Imaging System, M01

K212654

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

FDA 510(k) summary for Micro C Medical Imaging System, M01 (K212654)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
6
Cited predicates
1
Performance observations
0
Product code
IZL
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.9)
“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.”
PCCPNo
Cybersecurity addressedNo

Validation studies (6)

Bench

sample size not stated

endpoints: mean squared error; mean absolute error

standards: FDA's Proposed Regulatory Framework for Modifications to Artificial intelligence/Machine Learning (AI/ML) Based Software as a Medical Device (SaMD)(2019)

Bench

sample size not stated

endpoints: software met system-level software requirements; software outputs met the expected result

standards: IEC 62304:2015, Medical device software - Software life cycle processes, ISO 14971:2019, Medical Devices – Application of Risk Management to Medical Devices

Bench

sample size not stated

endpoints: images were determined to be diagnostically and clinically relevant

Bench

sample size not stated

endpoints: acceptable amount of radiation was delivered; AILARA dose values were below the established Diagnostic Reference Levels

Bench

sample size not stated

endpoints: acceptable amount of radiation was delivered; AILARA dose values were below the established Diagnostic Reference Levels (DRLs) for small size anatomies

standards: Pediatric Information for X-ray Imaging Device Premarket Notifications (2017)

Bench

n=15 other

endpoints: acceptable use-related risks and effectiveness during use; identified critical use tasks were completed with a passing result by 100% of participants

standards: IEC 62366-1:2020, Medical devices - Part 1: Application of usability engineering to medical devices, Guidance for Industry and FDA Staff – Applying Human Factors and Usability Engineering to Medical Devices (2016)

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

25
recalls in product code, 24mo
26
MAUDE reports in code, 12mo
-46%
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 2026-08-19.

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/K212654