# K030185: Endos AC/Acp

- Pathway: 510(k) (Abbreviated)
- Applicant: Villa Sistemi Medicali S.P.A.
- Decided: Mar 11, 2003 after 49 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: 2 generations back to K950667 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984524: Aztech 70, Villa Sistemi Medicali S.P.A. (1999) Summary page 1.

## Indications for use
extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

Source page: https://510kreport.com/device/K030185
Methodology: https://510kreport.com/methodology