FDA 510(k)

IMACTIS CT-나비게이션 시스템

K-번호: K162314 · 2018-04-24

결정일2018-04-24

제품 코드JAK

자문 위원회RA

결정Substantially Equivalent

기기 요약

IMACTIS CT-Navigation system is the device name listed in this FDA 510(k) record. The listed applicant is Imactis, Sas. It received FDA 510(k) clearance on 2018-04-24 under 510(k) number K162314. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the IMACTIS CT-Navigation system?

IMACTIS CT-Navigation system is a medical device that received FDA 510(k) clearance on 2018-04-24. The listed applicant is Imactis, Sas. The 510(k) number is K162314.

When did IMACTIS CT-Navigation system receive FDA 510(k) clearance?

IMACTIS CT-Navigation system received FDA 510(k) clearance on 2018-04-24, under 510(k) number K162314.

Who is the listed applicant for IMACTIS CT-Navigation system?

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

What is the FDA product code for IMACTIS CT-Navigation system?

The FDA product code for IMACTIS CT-Navigation system is JAK.

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FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

IMACTIS CT-나비게이션 시스템

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: JAK)

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