FDA 510(k)

X-라이프 플랫 패널 디터ktör (에버레스트뷰 4343X)

K-번호: K223687 · 2022-12-30

신청자Careray Digital Medical Technology Co., Ltd.

결정일2022-12-30

제품 코드MQB

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

결정대체적으로 동일

기기 요약

X-ray Flat Panel Detectors (EverestView 4343X) is the device name listed in this FDA 510(k) record. The listed applicant is Careray Digital Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-30 under 510(k) number K223687. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the X-ray Flat Panel Detectors (EverestView 4343X)?

X-ray Flat Panel Detectors (EverestView 4343X) is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Careray Digital Medical Technology Co., Ltd.. The 510(k) number is K223687.

When did X-ray Flat Panel Detectors (EverestView 4343X) receive FDA 510(k) clearance?

X-ray Flat Panel Detectors (EverestView 4343X) received FDA 510(k) clearance on 2022-12-30, under 510(k) number K223687.

Who is the listed applicant for X-ray Flat Panel Detectors (EverestView 4343X)?

The FDA 510(k) record lists Careray Digital Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-ray Flat Panel Detectors (EverestView 4343X)?

The FDA product code for X-ray Flat Panel Detectors (EverestView 4343X) is MQB.

Careray Digital Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K232058요세미티뷰 4343W/요세미티뷰 3643W K221549X-라이프 플랫 패널 디터کت러 (CareView 1800 RF)

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