# K965203: Radx System

- Pathway: 510(k) (Traditional)
- Applicant: Electro Medical Systems, Inc.
- Decided: Mar 17, 1997 after 81 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- 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
Longest line of descent: 1 generation back to K914376 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914376: DXS Digital X-Ray Subtraction, Philips Medical Systems (Cleveland), Inc. (1992) Summary page 1.

## Indications for use
The RAD,, System digitizes and processes dental radiographs to perform longitudinal radiographic analysis using the digital subtraction technique. This technique is helpful in the detection of hard tissue changes including pathologies as well as resolution of those same pathologies.

Source page: https://510kreport.com/device/K965203
Methodology: https://510kreport.com/methodology