FDA 510(k)

Pinnacle Radiation Therapy Planning System

Número K: K170086 · 2017-02-09

RequerentePhilips Medical Systems (Cleveland), Inc.

Data da decisão2017-02-09

Código do produtoMUJ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pinnacle Radiation Therapy Planning System 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 2017-02-09 under 510(k) number K170086. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pinnacle Radiation Therapy Planning System?

Pinnacle Radiation Therapy Planning System is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K170086.

When did Pinnacle Radiation Therapy Planning System receive FDA 510(k) clearance?

Pinnacle Radiation Therapy Planning System received FDA 510(k) clearance on 2017-02-09, under 510(k) number K170086.

Who is the listed applicant for Pinnacle Radiation Therapy Planning System?

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 Pinnacle Radiation Therapy Planning System?

The FDA product code for Pinnacle Radiation Therapy Planning System is MUJ.

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Fonte oficial

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