# K002432: Strato X

- Pathway: 510(k) (Traditional)
- Applicant: Villa Sistemi Medicali S.P.A.
- Decided: Sep 1, 2000 after 24 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.
32 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

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

Source page: https://510kreport.com/device/K002432
Methodology: https://510kreport.com/methodology