# K081664: Nomad Pro X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Aribex, Inc.
- Decided: Jun 23, 2008 after 10 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000061 (2000). 3 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051795: Nomad Dental X-Ray System, Aribex, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K0063121: Port-X 11 Portable X-ray System. Number could not be read Summary page 1.

## Most influential descendants
- K173319: KaVo NOMAD Pro 2 Handheld X-ray System (2017), 9 descendants of its own
- K161063: EzRay Air (Model VEX-P300) (2016), 5 descendants of its own
- K200182: EzRay Air Portable (Model: VEX-P300) (2020), 4 descendants of its own
- K222569: Ai Ray Dental X-Ray Device (2022), 1 descendant of its own
- K221233: DT-703 (2022), 1 descendant of its own

## Recalls of this device
- Jul 18, 2016 · Class II · Z-2717-2016: Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium 
- Jul 18, 2016 · Class II · Z-2716-2016: Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium 

## Indications for use
The NOMAD Pro 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/K081664
Methodology: https://510kreport.com/methodology