# K962422: Infimed Dental System

- Pathway: 510(k) (Traditional)
- Applicant: Infimed, Inc.
- Decided: Sep 11, 1997 after 444 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
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
InfiMed Dental System is an image acquisition and management system that allows acquisition, processing, display, and print of filmless radiographs and/or color dental images. It consists of various components that acquire, store, display, and print radiographs and/or color dental images with patient information. Its capabilities include: Color image acquisition takes place from a standard S-video color camera. Radiograph acquisition takes place from a Charge Coupled Device (CCD) camera designed for the application. Images can be directly printed and displayed on standard s-video equipment or transferred to a personal computer for acquisition and storage. If images are stored on the personal computer, dental image management software is utilized for patient data input, image processing, and image display on the computer monitor. In addition, printed reports are available from the personal computer.

Source page: https://510kreport.com/device/K962422
Methodology: https://510kreport.com/methodology