# K962631: Dexis Model 601 Dental Electronic Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Fair Image, Inc.
- Decided: Nov 26, 1996 after 144 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K090431: Dexis Software (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K962631
Methodology: https://510kreport.com/methodology