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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 the device name listed in this FDA 510(k) record. The listed applicant is Oxos Medical. It received FDA 510(k) clearance on 2025-12-22 under 510(k) 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. The listed applicant is Oxos Medical. The 510(k) number is K252068.

When did MC2 Portable X-ray System receive FDA 510(k) clearance?

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

Who is the listed applicant for MC2 Portable X-ray System?

The FDA 510(k) record lists Oxos Medical as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Oxos Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241567MC2 Portable X-ray SystemK212654Micro C Medical Imaging System, M01K211473Micro C Medical Imaging System, M01K203658Micro C Medical Imaging System, M01

Related Devices (Code: OWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.

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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