# K961826: Digipan

- Pathway: 510(k) (Traditional)
- Applicant: Trophy Radiologie
- Decided: Sep 23, 1996 after 133 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.
37 later devices descend from it; 2 cite it directly.
0 of 38 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
- K983283: Signet Dxis Direct X-Ray Imaging System (1998), 36 descendants of its own
- K041120: EV Apan Digital, Model K1VSM2000 (2004), 32 descendants of its own
- K090749: Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191 (2009), 30 descendants of its own
- K111152: Rotograph Evo 3D (2011), 27 descendants of its own
- K122981: Rayscan a-Expert 3D (2013), 24 descendants of its own

Source page: https://510kreport.com/device/K961826
Methodology: https://510kreport.com/methodology