FDA 510(k)

MC2 便携式 X 射线系统

K号: K252068 · 2025-12-22

决定日期2025-12-22

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Oxos Medical为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241567MC2 便携式 X 射线系统

官方来源

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