# K080847: Rfvision, Model 9.9D

- Pathway: 510(k) (Traditional)
- Applicant: Almana Medical Imaging
- Decided: Aug 6, 2008 after 133 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: 3 generations back to K911454 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061173: Cpivision Digital Imaging System, Communications & Power Industries Canada, Inc. (2006) Summary page 2.

## Indications for use
The RFVision 9.9D 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 RFVision 9.9D 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.

Source page: https://510kreport.com/device/K080847
Methodology: https://510kreport.com/methodology