FDA 510(k)

DrAid for Radiology v1

K号: K221241 · 2022-09-01

决定日期2022-09-01

产品代码QFM

咨询委员会RA

决定实质等同

器械摘要

DrAid for Radiology v1 is the device name listed in this FDA 510(k) record. The listed applicant is Vinbrain Joint Stock Company. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K221241. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DrAid for Radiology v1?

DrAid for Radiology v1 is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Vinbrain Joint Stock Company. The 510(k) number is K221241.

When did DrAid for Radiology v1 receive FDA 510(k) clearance?

DrAid for Radiology v1 received FDA 510(k) clearance on 2022-09-01, under 510(k) number K221241.

Who is the listed applicant for DrAid for Radiology v1?

The FDA 510(k) record lists Vinbrain Joint Stock Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DrAid for Radiology v1?

The FDA product code for DrAid for Radiology v1 is QFM.

列明Vinbrain Joint Stock Company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。

K241543DrAid® 肝脏分割设备

官方来源

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