FDA 510(k)

CAAS MR 솔루션

K-번호: K181825 · 2018-12-04

결정일2018-12-04

제품 코드LLZ

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

결정대체적으로 동일

기기 요약

CAAS MR Solutions 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 2018-12-04 under 510(k) number K181825. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the CAAS MR Solutions?

CAAS MR Solutions is a medical device that received FDA 510(k) clearance on 2018-12-04. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K181825.

When did CAAS MR Solutions receive FDA 510(k) clearance?

CAAS MR Solutions received FDA 510(k) clearance on 2018-12-04, under 510(k) number K181825.

Who is the listed applicant for CAAS MR Solutions?

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 MR Solutions?

The FDA product code for CAAS MR Solutions is LLZ.

Pie Medical Imaging BV를 신청인으로 등재한 기타 기록

K2503303mensio Workstation K232147CAAS Workstation K232007CAAS MR 솔루션 K212376캐스 Qardia K180019CAAS Workstation K162376CAAS MR 4D 플로우

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