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FDA 510(k)

Micro C Medical Imaging System, M01

K-Number: K212654 · 2022-02-04

ApplicantOxos Medical, Inc.
Decision Date2022-02-04
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Micro C Medical Imaging System, M01 is a medical device manufactured by Oxos Medical, Inc.. It received FDA 510(k) clearance on 2022-02-04 under approval number K212654. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Micro C Medical Imaging System, M01?

Micro C Medical Imaging System, M01 is a medical device that received FDA 510(k) clearance on 2022-02-04. It is manufactured by Oxos Medical, Inc.. The 510(k) number is K212654.

When was Micro C Medical Imaging System, M01 approved by the FDA?

Micro C Medical Imaging System, M01 received FDA 510(k) clearance on 2022-02-04, under approval number K212654.

What company makes Micro C Medical Imaging System, M01?

Micro C Medical Imaging System, M01 is manufactured by Oxos Medical, Inc..

What is the FDA product code for Micro C Medical Imaging System, M01?

The FDA product code for Micro C Medical Imaging System, M01 is IZL.

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Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

Other Devices by Oxos Medical, Inc.

K211473Micro C Medical Imaging System, M01 K203658Micro C Medical Imaging System, M01

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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