FDA 510(k)

히스토롭® 스캐너 (하드웨어 2.4, 소프트웨어 3.3)

K-번호: K241275 · 2024-08-19

결정일2024-08-19

제품 코드OWN

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Histolog® Scanner (Hardware 2.4, Software 3.3) is the device name listed in this FDA 510(k) record. The listed applicant is Samantree Medical SA. It received FDA 510(k) clearance on 2024-08-19 under 510(k) number K241275. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Histolog® Scanner (Hardware 2.4, Software 3.3)?

Histolog® Scanner (Hardware 2.4, Software 3.3) is a medical device that received FDA 510(k) clearance on 2024-08-19. The listed applicant is Samantree Medical SA. The 510(k) number is K241275.

When did Histolog® Scanner (Hardware 2.4, Software 3.3) receive FDA 510(k) clearance?

Histolog® Scanner (Hardware 2.4, Software 3.3) received FDA 510(k) clearance on 2024-08-19, under 510(k) number K241275.

Who is the listed applicant for Histolog® Scanner (Hardware 2.4, Software 3.3)?

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

What is the FDA product code for Histolog® Scanner (Hardware 2.4, Software 3.3)?

The FDA product code for Histolog® Scanner (Hardware 2.4, Software 3.3) is OWN.

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히스토롭® 스캐너 (하드웨어 2.4, 소프트웨어 3.3)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OWN)

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