FDA 510(k)

Biograph Horizon PET/CT

K-번호: K152880 · 2016-01-12

결정일2016-01-12

제품 코드KPS

자문 위원회RA

결정Substantially Equivalent

기기 요약

Biograph Horizon PET/CT is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K152880. 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 Biograph Horizon PET/CT?

Biograph Horizon PET/CT is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K152880.

When did Biograph Horizon PET/CT receive FDA 510(k) clearance?

Biograph Horizon PET/CT received FDA 510(k) clearance on 2016-01-12, under 510(k) number K152880.

Who is the listed applicant for Biograph Horizon PET/CT?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biograph Horizon PET/CT?

The FDA product code for Biograph Horizon PET/CT is KPS.

Siemens Medical Solutions USA, Inc.를 신청인으로 등재한 기타 기록

K260055syngo.CT Brain Quantification K261696아쿤아브 루세라 4D 아이스 캐瑟터 K260488MULTIX Impact; MULTIX Impact C K253786syngo.CT Coronary Cockpit K253678MAMMOMAT B.brilliant (11372950)K260844ACUSON Sequoia 진단 초음파 시스템;ACUSON Sequoia Select 진단 초음파 시스템;ACUSON Origin 진단 초음파 시스템;ACUSON Origin ICE 진단 초음파 시스템

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관련 기기 (코드: KPS)

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