# K061173: Cpivision Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Communications & Power Industries Canada, Inc.
- Decided: Jun 9, 2006 after 43 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: 2 generations back to K911454 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012490: Orion Digital Imaging System, Infimed, Inc. (2002) Summary page 2.

## Most influential descendants
- K080847: Rfvision, Model 9.9D (2008), 0 descendants of its own

## Indications for use
The CPIVision Digital 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 when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The CP1Vision Digital Imaging system allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images 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. The CPIVision Digital Imaging system enables the operator to hardcopy image with a laser printer or send images over a network. The major system includes: a fluoroscopic CCD camera/lens, monitors, and an image processor.

Source page: https://510kreport.com/device/K061173
Methodology: https://510kreport.com/methodology