FDA 510(k)

uOmnispace.MR

K号: K253077 · 2026-04-22

申请人Shanghai United Imaging Healthcare Co., Ltd.

决定日期2026-04-22

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

uOmnispace.MR is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2026-04-22 under 510(k) number K253077. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the uOmnispace.MR?

uOmnispace.MR is a medical device that received FDA 510(k) clearance on 2026-04-22. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K253077.

When did uOmnispace.MR receive FDA 510(k) clearance?

uOmnispace.MR received FDA 510(k) clearance on 2026-04-22, under 510(k) number K253077.

Who is the listed applicant for uOmnispace.MR?

FDA 510(k)记录将上海联影医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for uOmnispace.MR?

The FDA product code for uOmnispace.MR is QIH.

列明Shanghai United Imaging Healthcare Co., Ltd.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。

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