# K242591: XERO-alpha

- Pathway: 510(k) (Traditional)
- Applicant: DRTECH Corporation
- Decided: Nov 1, 2024 after 63 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: 6 generations back to K000061 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200182: EzRay Air Portable (Model: VEX-P300), VATECH Co., Ltd. (2020) Summary page 6.

## Indications for use
XERO α is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dentist or a dental technician for both adult and pediatric patients. This equipment is used in a professional healthcare facility environment.

Source page: https://510kreport.com/device/K242591
Methodology: https://510kreport.com/methodology