# K152859: Portable X-ray System (Model:  MINIX-V / MINIX-S)

- Pathway: 510(k) (Traditional)
- Applicant: Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)
- Decided: Dec 3, 2015 after 64 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: 5 generations back to K000061 (2000). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 14 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 4.
- K103600: Portable X-Ray System, Digimed Corporation (2011) Summary page 4.
- K082167: Portable X-Ray System, Models Diox-602, Prox, Digimed Corporation (2008) Summary page 4.

## Most influential descendants
- 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
- K254018: Portable Dental X-ray Device (GT-1) (2026), 0 descendants of its own

## Indications for use
The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic X-ray images using intra-oral image receptors. Its use is intended for both adults and pediatric subjects.

Source page: https://510kreport.com/device/K152859
Methodology: https://510kreport.com/methodology