FDA 510(k)

Hermes Medical Imaging Suite v5.7

Número K: K171681 · 2017-11-21

Data da decisão2017-11-21

Código do produtoKPS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hermes Medical Imaging Suite v5.7 is the device name listed in this FDA 510(k) record. The listed applicant is Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K171681. 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 Hermes Medical Imaging Suite v5.7?

Hermes Medical Imaging Suite v5.7 is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K171681.

When did Hermes Medical Imaging Suite v5.7 receive FDA 510(k) clearance?

Hermes Medical Imaging Suite v5.7 received FDA 510(k) clearance on 2017-11-21, under 510(k) number K171681.

Who is the listed applicant for Hermes Medical Imaging Suite v5.7?

The FDA 510(k) record lists Hermes Medical Solutions AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hermes Medical Imaging Suite v5.7?

The FDA product code for Hermes Medical Imaging Suite v5.7 is KPS.

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Outros registros que listam Hermes Medical Solutions AB como candidato(a)

K253835Affinity K252477Hybrid Viewer (00859873006240)K243919Voxel Dosimetry (00859873006226)K241364Hybrid Viewer (00859873006189)K202882Affinity K193152Affinity

Ver todos os 13 dispositivos →

Dispositivos Relacionados (Código: KPS)

Fonte oficial

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