# K093478: Kodak RVG 6500 System and Kodak RVG 6500 Ips System

- Pathway: 510(k) (Traditional)
- Applicant: Trophy
- Decided: Apr 26, 2010 after 168 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Kodak RVG 6500 wireless digital intraoral system is intended to replace dental ray film for any intraoral diagnostic purposes. It uses the wireless technology in order X- transmit the acquire image to a computer. It requires additional components such to as conventional extraoral X-ray source and visualization software The Kodak RVG 6500 IPS System, in addition, provides, the Intelligent Positioning System (IPS) to enable the dentist prior to acquisition to correctly align the X-ray beam to the RVG sensor.

Source page: https://510kreport.com/device/K093478
Methodology: https://510kreport.com/methodology