# K012514: Digipan / Dpi

- Pathway: 510(k) (Traditional)
- Applicant: Trophy Radiologie
- Decided: Dec 21, 2001 after 137 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- 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, DIGIPAN, can replace the conventional film for primary diagnostic purpose. The image generated is displayed on a computer monitor. 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. The DIGIPAN can be adapted on different types of panoramic X-ray units according to the attached installation manuals.

Source page: https://510kreport.com/device/K012514
Methodology: https://510kreport.com/methodology