FDA 510(k)

Viz LVO ContaCT

K-번호: K223042 · 2022-10-21

결정일2022-10-21

제품 코드QAS

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

결정Substantially Equivalent

기기 요약

Viz LVO ContaCT is the device name listed in this FDA 510(k) record. The listed applicant is Viz. Ai, Inc.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K223042. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Viz LVO ContaCT?

Viz LVO ContaCT is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Viz. Ai, Inc.. The 510(k) number is K223042.

When did Viz LVO ContaCT receive FDA 510(k) clearance?

Viz LVO ContaCT received FDA 510(k) clearance on 2022-10-21, under 510(k) number K223042.

Who is the listed applicant for Viz LVO ContaCT?

The FDA 510(k) record lists Viz. Ai, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Viz LVO ContaCT?

The FDA product code for Viz LVO ContaCT is QAS.

Viz. Ai, Inc.를 신청인으로 등재한 기타 기록

K250354Viz Subdural+, Viz SUBDURAL PLUS K232363Viz HDS, Viz Volume Plus, Viz ICH+K223443Viz AAA K221100Viz RV/LV K220439Viz SDH K213319Viz ANEURYSM, Viz ANX

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