FDA 510(k)

VERITON CT whole body SPECT/CT system

K-번호: K190457 · 2019-07-12

결정일2019-07-12

제품 코드KPS

자문 위원회RA

결정Substantially Equivalent

기기 요약

VERITON CT whole body SPECT/CT system is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Dynamics Medical, Ltd.. It received FDA 510(k) clearance on 2019-07-12 under 510(k) number K190457. 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 VERITON CT whole body SPECT/CT system?

VERITON CT whole body SPECT/CT system is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K190457.

When did VERITON CT whole body SPECT/CT system receive FDA 510(k) clearance?

VERITON CT whole body SPECT/CT system received FDA 510(k) clearance on 2019-07-12, under 510(k) number K190457.

Who is the listed applicant for VERITON CT whole body SPECT/CT system?

The FDA 510(k) record lists Spectrum Dynamics Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERITON CT whole body SPECT/CT system?

The FDA product code for VERITON CT whole body SPECT/CT system is KPS.

Spectrum Dynamics Medical, Ltd.를 신청인으로 등재한 기타 기록

K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)K253532TruSPECT Processing Station K230600VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)K212230TruSPECT Radiological Image Processing Station K182484VERITON CT whole body SPECT/CT system K180514VERITON NM

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