FDA 510(k)

methinks NCCT 스트로크

K-번호: K250685 · 2025-06-16

결정일2025-06-16

제품 코드QAS

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

결정대체적으로 동일

기기 요약

Methinks NCCT Stroke is the device name listed in this FDA 510(k) record. The listed applicant is Methinks Software, S.L. It received FDA 510(k) clearance on 2025-06-16 under 510(k) number K250685. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Methinks NCCT Stroke?

Methinks NCCT Stroke is a medical device that received FDA 510(k) clearance on 2025-06-16. The listed applicant is Methinks Software, S.L. The 510(k) number is K250685.

When did Methinks NCCT Stroke receive FDA 510(k) clearance?

Methinks NCCT Stroke received FDA 510(k) clearance on 2025-06-16, under 510(k) number K250685.

Who is the listed applicant for Methinks NCCT Stroke?

The FDA 510(k) record lists Methinks Software, S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Methinks NCCT Stroke?

The FDA product code for Methinks NCCT Stroke is QAS.

Methinks Software, S.L를 신청인으로 등재한 기타 기록

K251590methinks CTA 스트로크

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