FDA 510(k)

Lumify Diagnostic Ultrasound System

Número K: K192226 · 2019-09-06

Data da decisão2019-09-06

Código do produtoIYN

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lumify Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Health Care. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K192226. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Lumify Diagnostic Ultrasound System?

Lumify Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Philips Health Care. The 510(k) number is K192226.

When did Lumify Diagnostic Ultrasound System receive FDA 510(k) clearance?

Lumify Diagnostic Ultrasound System received FDA 510(k) clearance on 2019-09-06, under 510(k) number K192226.

Who is the listed applicant for Lumify Diagnostic Ultrasound System?

The FDA 510(k) record lists Philips Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lumify Diagnostic Ultrasound System?

The FDA product code for Lumify Diagnostic Ultrasound System is IYN.

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Outros registros que listam Philips Health Care como candidato(a)

K2013523D Auto LAA K200974QLAB Advanced Quantification Software K200179Collaboration Live K191647QLAB Advanced Quantification Software K190913QLAB Advanced Quantification Software 13 K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

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Dispositivos Relacionados (Código: IYN)

Fonte oficial

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