# K012490: Orion Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Infimed, Inc.
- Decided: Feb 12, 2002 after 193 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911454 (1991). 2 ancestors in all.
33 later devices descend from it; 4 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963037: Patriot, Infimed, Inc. (1996) Summary page 1.
- K911454: FC2000, S & S Inficon, Inc. (1991) Summary page 1.

## Most influential descendants
- K093066: I5 Digital X-Ray Imaging System, Model I5 (2010), 22 descendants of its own
- K103416: Nexus DRF Digital X-Ray Imaging System (2011), 17 descendants of its own
- K130318: Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB) (2013), 15 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
The InfiMed Orion Fluoroscopic imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The Orion system allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images ( 1024x1024) may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for medium term storage. The Orion system enables the operator to hardcopy image with a laser printer or send images over a network for longer term storage. The major system components include: a fluoroscopic TV camera, monitors, and an image processor.

Source page: https://510kreport.com/device/K012490
Methodology: https://510kreport.com/methodology