# K110040: Omnivision

- Pathway: 510(k) (Traditional)
- Applicant: Modern Module, Inc.
- Decided: Jan 26, 2011 after 20 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: 6 generations back to K896095 (1990). 8 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070618: Dicompacs, Model 5, Oehm Und Rehbein GmbH (2007) Summary page 1.

## Most influential descendants
- K112132: Krystalrad 660 Digital Radiographic Portable Retrofit System (2011), 14 descendants of its own
- K130883: Sedecal Digital Radiographic Upgrade Model Sdru-T (2013), 11 descendants of its own
- K140825: Delworks DR System (2014), 7 descendants of its own
- K162529: DigiX FDX (2017), 6 descendants of its own
- K192541: DigiX FDX (2019), 5 descendants of its own

## Indications for use
OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical Images. OmniVision receives imaiges from imaging modalities via DICOM or imported directly. It archives and displays these images for the use of medical specialists who are qualified to operate radiological equipment and to record and diagnose medical images. It provides the user with a range of tools to assist them in viewing the images, such as zoom. filters and measurements, and with facilities to exchange images with other specialists. OmniVision is not intended for the acquisition of mammographic image data.

Source page: https://510kreport.com/device/K110040
Methodology: https://510kreport.com/methodology