FDA 510(k)

유니신 분자 이미징 (6-3-1)

K-번호: K231047 · 2023-09-01

결정일2023-09-01

제품 코드LLZ

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

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기기 요약

UniSyn Molecular Imaging (6-3-1) is the device name listed in this FDA 510(k) record. The listed applicant is Convergent Imaging Solutions. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K231047. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the UniSyn Molecular Imaging (6-3-1)?

UniSyn Molecular Imaging (6-3-1) is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Convergent Imaging Solutions. The 510(k) number is K231047.

When did UniSyn Molecular Imaging (6-3-1) receive FDA 510(k) clearance?

UniSyn Molecular Imaging (6-3-1) received FDA 510(k) clearance on 2023-09-01, under 510(k) number K231047.

Who is the listed applicant for UniSyn Molecular Imaging (6-3-1)?

The FDA 510(k) record lists Convergent Imaging Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UniSyn Molecular Imaging (6-3-1)?

The FDA product code for UniSyn Molecular Imaging (6-3-1) is LLZ.

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유니신 분자 이미징 (6-3-1)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LLZ)

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