FDA 510(k)

Change Healthcare 생리적 AI

K-번호: K210719 · 2021-07-20

결정일2021-07-20

제품 코드QIH

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

결정대체적으로 동일

기기 요약

Change Healthcare Anatomical AI is the device name listed in this FDA 510(k) record. The listed applicant is Change Healthcare Canada Company. It received FDA 510(k) clearance on 2021-07-20 under 510(k) number K210719. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Change Healthcare Anatomical AI?

Change Healthcare Anatomical AI is a medical device that received FDA 510(k) clearance on 2021-07-20. The listed applicant is Change Healthcare Canada Company. The 510(k) number is K210719.

When did Change Healthcare Anatomical AI receive FDA 510(k) clearance?

Change Healthcare Anatomical AI received FDA 510(k) clearance on 2021-07-20, under 510(k) number K210719.

Who is the listed applicant for Change Healthcare Anatomical AI?

The FDA 510(k) record lists Change Healthcare Canada Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Change Healthcare Anatomical AI?

The FDA product code for Change Healthcare Anatomical AI is QIH.

Change Healthcare Canada Company를 신청인으로 등재한 기타 기록

K241981케인헬스케어 스트라투스 이미징 PACS K181185변경의료 기업 뷰어

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