FDA 510(k)

옵션 스크린 디스플레이: HeartSee 심장 P.E.T. 처리 소프트웨어 - HeartSee 버전 4

K-번호: K231731 · 2023-08-21

결정일2023-08-21

제품 코드KPS

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

결정대체적으로 동일

기기 요약

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is the device name listed in this FDA 510(k) record. The listed applicant is Mcgovern Medical School. It received FDA 510(k) clearance on 2023-08-21 under 510(k) number K231731. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is a medical device that received FDA 510(k) clearance on 2023-08-21. The listed applicant is Mcgovern Medical School. The 510(k) number is K231731.

When did Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 receive FDA 510(k) clearance?

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 received FDA 510(k) clearance on 2023-08-21, under 510(k) number K231731.

Who is the listed applicant for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

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

What is the FDA product code for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

The FDA product code for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is KPS.

Mcgovern Medical School를 신청인으로 등재한 기타 기록

K202679옵션 스크린 디스플레이를 위한 HeartSee 심장 P.E.T. 처리 소프트웨어 - HeartSee 버전 3

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