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FDA 510(k)

MC2 Portable X-ray System

K-Number: K252068 · 2025-12-22

ApplicantOxos Medical
Decision Date2025-12-22
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MC2 Portable X-ray System is a medical device manufactured by Oxos Medical. It received FDA 510(k) clearance on 2025-12-22 under approval number K252068. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MC2 Portable X-ray System?

MC2 Portable X-ray System is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Oxos Medical. The 510(k) number is K252068.

When was MC2 Portable X-ray System approved by the FDA?

MC2 Portable X-ray System received FDA 510(k) clearance on 2025-12-22, under approval number K252068.

What company makes MC2 Portable X-ray System?

MC2 Portable X-ray System is manufactured by Oxos Medical.

What is the FDA product code for MC2 Portable X-ray System?

The FDA product code for MC2 Portable X-ray System is OWB.

Related Clinical Trials

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Other Devices by Oxos Medical

K241567MC2 Portable X-ray System

Related Devices (Code: OWB)

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Official Source

View on FDA Database →

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

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