# K013271: DXS Digital X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Douglas C. Yoon, Dds
- Decided: Dec 13, 2001 after 73 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K033147: Cleartooth Digital X-Ray System (2003), 0 descendants of its own

## Indications for use
An extraoral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

Source page: https://510kreport.com/device/K013271
Methodology: https://510kreport.com/methodology