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.
Enforcement
- Recall Number
- Z-0469-2014
- Event ID
- 66596
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Omnyx Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2013
- Initiation Date
- October 1, 2013
- Classification Date
- December 9, 2013
- Termination Date
- April 16, 2014
- Address
- 30 Isabella St, Pittsburgh, PA, 15212-5862, United States
Description
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.
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.
catalog # OMN-1005056-1, K1600LH, DPS 1.1
International Distribution to Canada and Switzerland only.
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