# K012379: PDX-2000 Portable Digital X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Trex Enterprises Corp.
- Decided: Aug 16, 2001 after 21 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945707 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973712: Minxray HF100H High Frequency Diagnostic X-Ray Unit, Minxray, Inc. (1997) Summary page 1.
- K981556: Canon X-Ray Digital Camera Cxdi-11, Canon USA, Inc. (1998) Summary page 1.
- K992547: Canon X-Ray Digital Camera, Model Cxdi-22, Canon USA, Inc. (1999) Summary page 1.

## Indications for use
The PDX-2000 Portable Digital X-Ray System provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.

Source page: https://510kreport.com/device/K012379
Methodology: https://510kreport.com/methodology