# K233395: Portable Dental X-Ray  (AXR60 S); Portable Dental X-Ray  (AXR65 S)

- Pathway: 510(k) (Abbreviated)
- Applicant: Alliage S/A Industrias Médico Odontológica
- Decided: Jan 3, 2024 after 92 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: 5 generations back to K000061 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173319: KaVo NOMAD Pro 2 Handheld X-ray System, Aribex (2017) Summary page 4.

## Indications for use
The Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.

Source page: https://510kreport.com/device/K233395
Methodology: https://510kreport.com/methodology