FDA 510(k)

RSI-MRI+

N.º K: K191278 · 2019-11-19

SolicitanteMultimodal Imaging Services Corporation (Dba Healthlytix)

Fecha de decisión2019-11-19

Código de productoLLZ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

RSI-MRI+ is the device name listed in this FDA 510(k) record. The listed applicant is Multimodal Imaging Services Corporation (Dba Healthlytix). It received FDA 510(k) clearance on 2019-11-19 under 510(k) number K191278. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the RSI-MRI+?

RSI-MRI+ is a medical device that received FDA 510(k) clearance on 2019-11-19. The listed applicant is Multimodal Imaging Services Corporation (Dba Healthlytix). The 510(k) number is K191278.

When did RSI-MRI+ receive FDA 510(k) clearance?

RSI-MRI+ received FDA 510(k) clearance on 2019-11-19, under 510(k) number K191278.

Who is the listed applicant for RSI-MRI+?

The FDA 510(k) record lists Multimodal Imaging Services Corporation (Dba Healthlytix) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RSI-MRI+?

The FDA product code for RSI-MRI+ is LLZ.

Dispositivos relacionados (Código: LLZ)

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Fuente oficial

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