FDA 510(k)

D-SPECT Processing and Reviewing Workstation

Número K: K160120 · 2016-03-21

Data da decisão2016-03-21

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

D-SPECT Processing and Reviewing Workstation is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Dynamics , Ltd.. It received FDA 510(k) clearance on 2016-03-21 under 510(k) number K160120. 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 Processing and Reviewing Workstation?

D-SPECT Processing and Reviewing Workstation is a medical device that received FDA 510(k) clearance on 2016-03-21. The listed applicant is Spectrum Dynamics , Ltd.. The 510(k) number is K160120.

When did D-SPECT Processing and Reviewing Workstation receive FDA 510(k) clearance?

D-SPECT Processing and Reviewing Workstation received FDA 510(k) clearance on 2016-03-21, under 510(k) number K160120.

Who is the listed applicant for D-SPECT Processing and Reviewing Workstation?

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

What is the FDA product code for D-SPECT Processing and Reviewing Workstation?

The FDA product code for D-SPECT Processing and Reviewing Workstation is KPS.

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