# K021378: Portable HDX Intraoral X-Ray

- Pathway: 510(k) (Traditional)
- Applicant: Dentalez Group
- Decided: Jun 7, 2002 after 37 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000061 (2000). 1 ancestor in all.
48 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000061: Minxray HF70D High Frequency Portable Dental X-Ray Unit, Minxray, Inc. (2000)

## Most influential descendants
- K051795: Nomad Dental X-Ray System (2005), 47 descendants of its own
- K063121: Portable X-Ray System, Model Port-X II (2007), 24 descendants of its own
- K082167: Portable X-Ray System, Models Diox-602, Prox (2008), 18 descendants of its own
- K081664: Nomad Pro X-Ray System (2008), 17 descendants of its own
- K173319: KaVo NOMAD Pro 2 Handheld X-ray System (2017), 9 descendants of its own

## Recalls of this device
- May 16, 2003 · Not classified · Z-1272-02: problems with product label

## Indications for use
The Portable HDX Intraoral X-ray unit is intended for use only by a qualifiedtrained dentist or dental technician on both adult and pediatric subjects for taking diagnostic extraoral dental x-rays using intraoral image receptors.

Source page: https://510kreport.com/device/K021378
Methodology: https://510kreport.com/methodology