# K082167: Portable X-Ray System, Models Diox-602, Prox

- Pathway: 510(k) (Traditional)
- Applicant: Digimed Corporation
- Decided: Sep 26, 2008 after 57 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: 4 generations back to K000061 (2000). 4 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063121: Portable X-Ray System, Model Port-X II, Genoray Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K122016: Rextar, Rextar LCD (2013), 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
- K180561: MobileX Portable X-ray System (2018), 5 descendants of its own
- K232068: HyperLight Portable X-ray Unit (2023), 2 descendants of its own

## Recalls of this device
- Jun 19, 2025 · Class II · Z-2117-2025: Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.

## Indications for use
The Portable X-ray System (Model: DIOX-602, PROX) is intended to be used by trained dentists and dental technicians as 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/K082167
Methodology: https://510kreport.com/methodology