# K103600: Portable X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Digimed Corporation
- Decided: Apr 8, 2011 after 121 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.
8 later devices descend from it; 1 cites it directly.
0 of 13 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
- K152859: Portable X-ray System (Model:  MINIX-V / MINIX-S) (2015), 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
- K231449: Portable X-ray System Model Ray98(P) (2023), 1 descendant of its own
- K260795: Hand-held Dental X-ray System (HyperLight-M) (2026), 0 descendants of its own

## Indications for use
The Portable X-ray System (Model: BIOX) is intended to be used by trained dentists and dental technicians as extra-oral 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/K103600
Methodology: https://510kreport.com/methodology