FDA 510(k)

便携式X射线系统型号Ray98(P)

K号: K231449 · 2023-07-13

申请人Ningbo Runyes Medical Instrument Co., Ltd.

决定日期2023-07-13

产品代码EHD

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决定实质等同

器械摘要

Portable X-ray System Model Ray98(P) 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 2023-07-13 under 510(k) number K231449. 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 Portable X-ray System Model Ray98(P)?

Portable X-ray System Model Ray98(P) is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is Ningbo Runyes Medical Instrument Co., Ltd.. The 510(k) number is K231449.

When did Portable X-ray System Model Ray98(P) receive FDA 510(k) clearance?

Portable X-ray System Model Ray98(P) received FDA 510(k) clearance on 2023-07-13, under 510(k) number K231449.

Who is the listed applicant for Portable X-ray System Model Ray98(P)?

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 Portable X-ray System Model Ray98(P)?

The FDA product code for Portable X-ray System Model Ray98(P) 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。

K252909诊断型X射线设备型号POCT22

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