FDA 510(k)

诊断型X射线设备型号POCT22

K号: K252909 · 2026-02-03

申请人Ningbo Runyes Medical Instrument Co., Ltd.

决定日期2026-02-03

产品代码EHD

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决定实质等同

器械摘要

Diagnostic X-Ray Equipment Model POCT22 is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Runyes Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-02-03 under 510(k) number K252909. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Diagnostic X-Ray Equipment Model POCT22?

Diagnostic X-Ray Equipment Model POCT22 is a medical device that received FDA 510(k) clearance on 2026-02-03. The listed applicant is Ningbo Runyes Medical Instrument Co., Ltd.. The 510(k) number is K252909.

When did Diagnostic X-Ray Equipment Model POCT22 receive FDA 510(k) clearance?

Diagnostic X-Ray Equipment Model POCT22 received FDA 510(k) clearance on 2026-02-03, under 510(k) number K252909.

Who is the listed applicant for Diagnostic X-Ray Equipment Model POCT22?

The FDA 510(k) record lists Ningbo Runyes Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diagnostic X-Ray Equipment Model POCT22?

The FDA product code for Diagnostic X-Ray Equipment Model POCT22 is EHD.

列明Ningbo Runyes Medical Instrument 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。

K231449便携式X射线系统型号Ray98(P)

官方来源

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