FDA 510(k)

Exam Vue PACS

N.º K: K162868 · 2017-03-17

SolicitanteJpi Healthcare Solutions, Inc.

Fecha de decisión2017-03-17

Código de productoLLZ

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Exam Vue PACS is the device name listed in this FDA 510(k) record. The listed applicant is Jpi Healthcare Solutions, Inc.. It received FDA 510(k) clearance on 2017-03-17 under 510(k) number K162868. 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 Exam Vue PACS?

Exam Vue PACS is a medical device that received FDA 510(k) clearance on 2017-03-17. The listed applicant is Jpi Healthcare Solutions, Inc.. The 510(k) number is K162868.

When did Exam Vue PACS receive FDA 510(k) clearance?

Exam Vue PACS received FDA 510(k) clearance on 2017-03-17, under 510(k) number K162868.

Who is the listed applicant for Exam Vue PACS?

The FDA 510(k) record lists Jpi Healthcare Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exam Vue PACS?

The FDA product code for Exam Vue PACS is LLZ.

Dispositivos relacionados (Código: LLZ)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio AnalysisReplasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.