FDA 510(k)

CAAS Workstation

K-번호: K151780 · 2016-03-11

결정일2016-03-11

제품 코드IZI

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

결정대체적으로 동일

기기 요약

CAAS Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Imaging BV. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K151780. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CAAS Workstation?

CAAS Workstation is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K151780.

When did CAAS Workstation receive FDA 510(k) clearance?

CAAS Workstation received FDA 510(k) clearance on 2016-03-11, under 510(k) number K151780.

Who is the listed applicant for CAAS Workstation?

The FDA 510(k) record lists Pie Medical Imaging BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAAS Workstation?

The FDA product code for CAAS Workstation is IZI.

Pie Medical Imaging BV를 신청인으로 등재한 기타 기록

K2503303mensio Workstation K232147CAAS Workstation K232007CAAS MR 솔루션 K212376캐스 Qardia K181825CAAS MR 솔루션 K180019CAAS Workstation

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