# K213282: ERI Handheld Dental X-ray System (Model AG100)

- Pathway: 510(k) (Traditional)
- Applicant: Energy Resources International Co., Ltd. Hsinchu Branch
- Decided: Apr 4, 2022 after 185 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 5.

## Indications for use
ERI Handheld Dental X-Ray System (Model AG100) is intended for the purpose of using it for both adult and pediatric patients by qualified operators (e.g. dentist and/ or radiographer, etc.) regulated by competent authority of each country for producing diagnostic dental X-ray images.

Source page: https://510kreport.com/device/K213282
Methodology: https://510kreport.com/methodology