# K030544: RFX Fluroscopic Digital Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Vision, Inc.
- Decided: May 21, 2003 after 90 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 K963037 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 2.
- K991578: Smartspot 2000, Cmt Medical Technologies, Ltd. (1999) Summary page 2.
- K003434: Allegro TB, Allegro N, Adac Laboratories (2000) Summary page 2.

## Indications for use
The RFX Fluoroscopic 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 where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. The RFX system allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images (1000 x 1000) may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details that might be difficult or impossible to see using conventional imaging techniques. Images can be stored locally for medium term storage. The RFX system enables the operator to print hardcopy images with a laser printer or send images over a network for longer term storage. The major system components include: a fluoroscopic CCD Camera, monitors, and an image processor

Source page: https://510kreport.com/device/K030544
Methodology: https://510kreport.com/methodology