# K063121: Portable X-Ray System, Model Port-X II

- Pathway: 510(k) (Traditional)
- Applicant: Genoray Co., Ltd.
- Decided: Jan 11, 2007 after 91 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: 3 generations back to K000061 (2000). 3 ancestors in all.
24 later devices descend from it; 7 cite it directly.
0 of 28 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.

## Most influential descendants
- K082167: Portable X-Ray System, Models Diox-602, Prox (2008), 18 descendants of its own
- K122016: Rextar, Rextar LCD (2013), 8 descendants of its own
- K103600: Portable X-Ray System (2011), 8 descendants of its own
- K152859: Portable X-ray System (Model:  MINIX-V / MINIX-S) (2015), 7 descendants of its own
- K132041: Rextar X (2013), 7 descendants of its own

## Indications for use
The PORT-X II 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 pediatric subjects.

Source page: https://510kreport.com/device/K063121
Methodology: https://510kreport.com/methodology