FDA 510(k)

VERITON NM

Número K: K180514 · 2018-04-25

RequerenteSpectrum Dynamics Medical, Ltd.

Data da decisão2018-04-25

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

VERITON NM 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 2018-04-25 under 510(k) number K180514. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VERITON NM?

VERITON NM is a medical device that received FDA 510(k) clearance on 2018-04-25. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K180514.

When did VERITON NM receive FDA 510(k) clearance?

VERITON NM received FDA 510(k) clearance on 2018-04-25, under 510(k) number K180514.

Who is the listed applicant for VERITON NM?

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 NM?

The FDA product code for VERITON NM is KPS.

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Outros registros que listam Spectrum Dynamics Medical, Ltd. como candidato(a)

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 K190457VERITON CT whole body SPECT/CT system K182484VERITON CT whole body SPECT/CT system

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Dispositivos Relacionados (Código: KPS)

Fonte oficial

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