# K181891: Portable X-ray System (Model: MiniX-V, Mini X-S)

- Pathway: 510(k) (Traditional)
- Applicant: Digimed Co., Ltd.
- Decided: Aug 10, 2018 after 28 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.
No later device cites it as a predicate yet.
0 of 8 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 4.

## 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/K181891
Methodology: https://510kreport.com/methodology