FDA 510(k)

uAI 간편진단-대장

K-번호: K193271 · 2021-01-15

신청자Shanghai United Imaging Intelligence Co., Ltd.

결정일2021-01-15

제품 코드QFM

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

uAI EasyTriage-Rib is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K193271. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the uAI EasyTriage-Rib?

uAI EasyTriage-Rib is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. The 510(k) number is K193271.

When did uAI EasyTriage-Rib receive FDA 510(k) clearance?

uAI EasyTriage-Rib received FDA 510(k) clearance on 2021-01-15, under 510(k) number K193271.

Who is the listed applicant for uAI EasyTriage-Rib?

The FDA 510(k) record lists Shanghai United Imaging Intelligence Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for uAI EasyTriage-Rib?

The FDA product code for uAI EasyTriage-Rib is QFM.

Shanghai United Imaging Intelligence Co., Ltd.를 신청인으로 등재한 기타 기록

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