FDA 510(k)

HDR MRI 룬너 마커

K-번호: K180069 · 2018-04-27

결정일2018-04-27

제품 코드JAQ

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

결정대체적으로 동일

기기 요약

HDR MRI Lumen Marker is the device name listed in this FDA 510(k) record. The listed applicant is C4 Imaging, LLC. It received FDA 510(k) clearance on 2018-04-27 under 510(k) number K180069. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the HDR MRI Lumen Marker?

HDR MRI Lumen Marker is a medical device that received FDA 510(k) clearance on 2018-04-27. The listed applicant is C4 Imaging, LLC. The 510(k) number is K180069.

When did HDR MRI Lumen Marker receive FDA 510(k) clearance?

HDR MRI Lumen Marker received FDA 510(k) clearance on 2018-04-27, under 510(k) number K180069.

Who is the listed applicant for HDR MRI Lumen Marker?

The FDA 510(k) record lists C4 Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDR MRI Lumen Marker?

The FDA product code for HDR MRI Lumen Marker is JAQ.

C4 Imaging, LLC를 신청인으로 등재한 기타 기록

K192771C4 표지 마커 K171487시리우스 MRI 마커 NS

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