# K090749: Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191

- Pathway: 510(k) (Abbreviated)
- Applicant: Villa Sistemi Medicali S.P.A.
- Decided: May 18, 2009 after 59 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
Longest line of descent: 3 generations back to K961826 (1996). 8 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002432: Strato X, Villa Sistemi Medicali S.P.A. (2000) Summary page 1.
- K041120: EV Apan Digital, Model K1VSM2000, Afp Imaging Corp. (2004) Summary page 1.
- K062403: Imax Ceph Digital X-Ray Sensor, Owandy (2006) Summary page 1.

## Most influential descendants
- 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
- K142247: Rayscan a-Expert 3D (2015), 22 descendants of its own
- K160525: RCT700 (2016), 11 descendants of its own

## Indications for use
Rotograph EVO and Rotograph EVO D, panoramic x-ray imaging system with cephalostat, are extraoral source x-ray system, which are intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry.

Source page: https://510kreport.com/device/K090749
Methodology: https://510kreport.com/methodology