FDA 510(k)

PowerDR

Número K: K191504 · 2019-08-16

RequerenteRadiology Information Systems, Inc.

Data da decisão2019-08-16

Código do produtoJAA

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

PowerDR is the device name listed in this FDA 510(k) record. The listed applicant is Radiology Information Systems, Inc.. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K191504. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PowerDR?

PowerDR is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Radiology Information Systems, Inc.. The 510(k) number is K191504.

When did PowerDR receive FDA 510(k) clearance?

PowerDR received FDA 510(k) clearance on 2019-08-16, under 510(k) number K191504.

Who is the listed applicant for PowerDR?

The FDA 510(k) record lists Radiology Information Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerDR?

The FDA product code for PowerDR is JAA.

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