FDA 510(k)

이미지넷 SPECT

K-번호: K152503 · 2016-01-25

결정일2016-01-25

제품 코드KPS

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

결정대체적으로 동일

기기 요약

ImagenSPECT is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Imaging Technologies. It received FDA 510(k) clearance on 2016-01-25 under 510(k) number K152503. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ImagenSPECT?

ImagenSPECT is a medical device that received FDA 510(k) clearance on 2016-01-25. The listed applicant is Cardiovascular Imaging Technologies. The 510(k) number is K152503.

When did ImagenSPECT receive FDA 510(k) clearance?

ImagenSPECT received FDA 510(k) clearance on 2016-01-25, under 510(k) number K152503.

Who is the listed applicant for ImagenSPECT?

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

What is the FDA product code for ImagenSPECT?

The FDA product code for ImagenSPECT is KPS.

Cardiovascular Imaging Technologies를 신청인으로 등재한 기타 기록

K201933이미지언 SPECT 3.0 K173547이미지얼유니버설

관련 기기 (코드: KPS)

공식 출처

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