# K260367: Portable Dental X-ray System Model PDX nova

- Pathway: 510(k) (Traditional)
- Applicant: PDX Co., Ltd.
- Decided: May 27, 2026 after 112 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). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221233: DT-703, Ecotron Co., Ltd. (2022) Summary page 5.

## Indications for use
PDX nova is a portable dental X-ray system that captures radiographic images for dental diagnosis using intra-oral imaging receptors. Only trained and qualified dental practitioner or radiologist shall use PDX nova to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.

Source page: https://510kreport.com/device/K260367
Methodology: https://510kreport.com/methodology