# K172928: Portable X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Rolence Enterprise, Inc.
- Decided: Mar 16, 2018 after 172 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: 4 generations back to K000061 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081664: Nomad Pro X-Ray System, Aribex, Inc. (2008) Summary page 4.

## Indications for use
The XR-01 Portable X-Ray System is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and child subjects

Source page: https://510kreport.com/device/K172928
Methodology: https://510kreport.com/methodology