FDA 510(k)

Ingenuity TF

Número K: K172406 · 2017-10-06

RequerentePhilips Medical Systems (Cleveland), Inc.

Data da decisão2017-10-06

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ingenuity TF is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K172406. 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 Ingenuity TF?

Ingenuity TF is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K172406.

When did Ingenuity TF receive FDA 510(k) clearance?

Ingenuity TF received FDA 510(k) clearance on 2017-10-06, under 510(k) number K172406.

Who is the listed applicant for Ingenuity TF?

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

What is the FDA product code for Ingenuity TF?

The FDA product code for Ingenuity TF is KPS.

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Outros registros que listam Philips Medical Systems (Cleveland), Inc. como candidato(a)

K171850Philips CT Big Bore K162838Philips iCT CT System K163711IQon Spectral CT K170086Pinnacle Radiation Therapy Planning System K160743Philips Ingenuity CT K153444Philips Multislice CT System with Low Dose CT Lung Cancer

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Dispositivos Relacionados (Código: KPS)

Fonte oficial

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