# K130374: Omni-Vue 2 System

- Pathway: 510(k) (Special)
- Applicant: Genesis Digital Imaging, Inc.
- Decided: Aug 29, 2013 after 196 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010259 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073062: Omni-Vue System, Genesis Digital Imaging, Inc. (2008) Summary page 1.

## Indications for use
Omni-Vue 2Tm System is a software device that receives digital images and data from various sources (eg. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Device options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by FDA

Source page: https://510kreport.com/device/K130374
Methodology: https://510kreport.com/methodology