Device product
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.
Z-0469-2014
Product summary
- Firm
- Omnyx Llc
- Event
- Event 66596
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-0469-2014
Official wording
Reason: 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.
Code information: catalog # OMN-1005056-1, K1600LH, DPS 1.1
Distribution pattern: International Distribution to Canada and Switzerland only.
Derived failure modes
-
Device software or design
issue associated with Digital Pathology System (DPS) Software