FDA 510(k)

Focus HD 43探测器

K-번호: K213529 · 2022-03-29

결정일2022-03-29

제품 코드MQB

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

결정대체적으로 동일

기기 요약

Focus HD 43 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 2022-03-29 under 510(k) number K213529. 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 HD 43 Detector?

Focus HD 43 Detector is a medical device that received FDA 510(k) clearance on 2022-03-29. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K213529.

When did Focus HD 43 Detector receive FDA 510(k) clearance?

Focus HD 43 Detector received FDA 510(k) clearance on 2022-03-29, under 510(k) number K213529.

Who is the listed applicant for Focus HD 43 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 HD 43 Detector?

The FDA product code for Focus HD 43 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

21개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.