FDA 510(k)

D-SPECT Scanner, D-SPECT L Scanner

Número K: K161740 · 2016-11-04

RequerenteSpectrum Dynamics Medical, Ltd.

Data da decisão2016-11-04

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

D-SPECT Scanner, D-SPECT L Scanner 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 2016-11-04 under 510(k) number K161740. 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 D-SPECT Scanner, D-SPECT L Scanner?

D-SPECT Scanner, D-SPECT L Scanner is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Spectrum Dynamics Medical, Ltd.. The 510(k) number is K161740.

When did D-SPECT Scanner, D-SPECT L Scanner receive FDA 510(k) clearance?

D-SPECT Scanner, D-SPECT L Scanner received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161740.

Who is the listed applicant for D-SPECT Scanner, D-SPECT L Scanner?

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 D-SPECT Scanner, D-SPECT L Scanner?

The FDA product code for D-SPECT Scanner, D-SPECT L Scanner 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

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: KPS)

Fonte oficial

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