# K991912: Modification to Digipan

- Pathway: 510(k) (Traditional)
- Applicant: Trophy Radiologie
- Decided: Jun 22, 1999 after 15 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.
33 later devices descend from it; 1 cites it directly.
0 of 34 devices 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.

## Most influential descendants
- 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
- K131695: Rayscan a-Expert 3D (2013), 23 descendants of its own

## Indications for use
The Trophy Radiologie digital imaging kit is now designed for use with the following panoramic X-ray units: OP100, manufacturer Instrumentarium, K912893 OrthoSlice 051000, manufacturer ASAHI, K991455 pending Panoura Ultra, manufacturer YOSHIDA, K number unknown to us X-Caliber, manufacturer ASAHI, K number unknown to us The image generated is displayed on a computer monitor and can replace the conventional film for primary diagnostic purpose. The image can then be archived through computer storage and archival means. Referral copies of the image can be obtained with optional hard copy systems.

Source page: https://510kreport.com/device/K991912
Methodology: https://510kreport.com/methodology