# K180561: MobileX Portable X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Denterprise International, Inc.
- Decided: Apr 4, 2018 after 30 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: 6 generations back to K000061 (2000). 7 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K152859: Portable X-ray System (Model:  MINIX-V / MINIX-S), Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) (2015) Summary page 5.

## Most influential descendants
- 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
- K252909: Diagnostic X-Ray Equipment Model POCT22 (2026), 0 descendants of its own

## Indications for use
The MobileX Portable X-ray System 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 receptors. Its use is intended for both adults and pediatric subjects.

Source page: https://510kreport.com/device/K180561
Methodology: https://510kreport.com/methodology