# K134055: ADX4000W

- Pathway: 510(k) (Special)
- Applicant: Dexcowin Co., Ltd.
- Decided: May 9, 2014 after 129 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K190935: EZER, Portable X-ray System (2019), 0 descendants of its own

## Indications for use
Tne ADX40100W Cordless Portable Dental X-Ray System is indicated for use only by trained and qualified dentists or dental technicians for both adult and pediatric subjects for taking diagnostic extranral dental x-rays using digital sensors.

Source page: https://510kreport.com/device/K134055
Methodology: https://510kreport.com/methodology