# K111152: Rotograph Evo 3D

- Pathway: 510(k) (Abbreviated)
- Applicant: Villa Sistemi Medicali S.P.A.
- Decided: Jul 22, 2011 after 88 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K973598 (1997). 15 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090749: Roograph Evo, Model 9307XY11Z1, Rotograph Evo D, Model 9307XY1191, Villa Sistemi Medicali S.P.A. (2009) Summary page 1.
- K060328: Planmeca Promax 3D, Planmeca Oy (2006) Summary page 1.

## Most influential descendants
- 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
- K181452: RCT800 (2018), 10 descendants of its own

## Recalls of this device
- Aug 5, 2015 · Class II · Z-0128-2016: It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).

## Indications for use
Rotograph EVO 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth. jaw, and oral structures, specially for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dento maxillofacial 3D images. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified healthcare professionals.

Source page: https://510kreport.com/device/K111152
Methodology: https://510kreport.com/methodology