FDAFDA · Alimentos y medicamentos·N.º oficial Z-0469-2014
Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx" products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.
Publicado el 18 de diciembre de 2013 · Inicio del retiro: 1 de octubre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Omnyx Llc
- Distribuidor
- International Distribution to Canada and Switzerland only.
- Lote
- catalog # OMN-1005056-1, K1600LH, DPS 1.1
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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