FDA 510(k)

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)

K-번호: K161724 · 2017-04-28

결정일2017-04-28

제품 코드IYE

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

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기기 요약

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is the device name listed in this FDA 510(k) record. The listed applicant is Radiomed Corporation. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K161724. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Radiomed Corporation. The 510(k) number is K161724.

When did Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) receive FDA 510(k) clearance?

Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) received FDA 510(k) clearance on 2017-04-28, under 510(k) number K161724.

Who is the listed applicant for Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?

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

What is the FDA product code for Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)?

The FDA product code for Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) is IYE.

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Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: IYE)

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