# K073062: Omni-Vue System

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Digital Imaging, Inc.
- Decided: Mar 10, 2008 after 132 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: 4 generations back to K010259 (2001). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042311: Pacspartner, Medical Standard Co., Ltd. (2004) Summary page 1.

## Most influential descendants
- K092235: Beyondimage Workstation (2009), 1 descendant of its own
- K130374: Omni-Vue 2 System (2013), 0 descendants of its own
- K102435: Beyondimage Workstation (2010), 0 descendants of its own

## Indications for use
Omni-VueTM System is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F 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 must only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. The Omni-Vue device allows limited image processing capability: "sharpening preset" and window leveling function. For image editing; the only an "L"or "R"marker can be added to the image but it must be already defined in the original image DICOM header as received by the system. "L"or "R"can not be added to the image if left & right is not defined in the original image. The device provides scout line which is a reference line and is drawn on the AP image to display the location of the slice being viewed. In multi series images, whenever one image is clicked, scout line will be drawn on other series which is crossed direction.

Source page: https://510kreport.com/device/K073062
Methodology: https://510kreport.com/methodology