FDA 510(k)

포커스 43C探测器, 트리맥스 43C探测器

K-번호: K200622 · 2020-04-01

결정일2020-04-01

제품 코드MQB

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

결정대체적으로 동일

기기 요약

Focus 43C detector, TRIMAX 43C detector is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2020-04-01 under 510(k) number K200622. 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 Focus 43C detector, TRIMAX 43C detector?

Focus 43C detector, TRIMAX 43C detector is a medical device that received FDA 510(k) clearance on 2020-04-01. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K200622.

When did Focus 43C detector, TRIMAX 43C detector receive FDA 510(k) clearance?

Focus 43C detector, TRIMAX 43C detector received FDA 510(k) clearance on 2020-04-01, under 510(k) number K200622.

Who is the listed applicant for Focus 43C detector, TRIMAX 43C detector?

The FDA 510(k) record lists Iray Technology Taicang , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Focus 43C detector, TRIMAX 43C detector?

The FDA product code for Focus 43C detector, TRIMAX 43C detector is MQB.

Iray Technology Taicang , Ltd.를 신청인으로 등재한 기타 기록

K223010포터블 X선 시스템 K222886메르쿠 1717V K221714플랫폼 디텍터 K221345Wireless Digital Flat Panel Detector K220536디지털 플랫폼 패널探测器 K220668Wireless Digital Flat Panel Detector

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