FDA 510(k)

모바일 영상링 시스템, IRm, 루프-엑스 모바일 영상 로봇, 루프-엑스

K-번호: K203281 · 2020-12-22

결정일2020-12-22

제품 코드OWB

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

결정대체적으로 동일

기기 요약

Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X is the device name listed in this FDA 510(k) record. The listed applicant is Medphoton GmbH. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K203281. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X?

Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Medphoton GmbH. The 510(k) number is K203281.

When did Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X receive FDA 510(k) clearance?

Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X received FDA 510(k) clearance on 2020-12-22, under 510(k) number K203281.

Who is the listed applicant for Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X?

The FDA 510(k) record lists Medphoton GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X?

The FDA product code for Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X is OWB.

Medphoton GmbH를 신청인으로 등재한 기타 기록

K234067이미징링 m (버전 2.0); 루프-엑스 (버전 2.0); 루프-엑스 모바일 이미징 로봇 (버전 2.0)K191267이미징링 시스템 온 레일즈 K161400이미징링 시스템

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