# K070658: Dental Digital Panoramic/3D Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: E-Woo Technology
- Decided: Apr 5, 2007 after 27 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
66 later devices descend from it; 4 cite it directly.
0 of 67 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
- K090171: Computed Tomography X-Ray System, Pax-REVE3D (2009), 59 descendants of its own
- K102259: Dental Computed Tomography X-Ray System (2011), 42 descendants of its own
- K121412: Pax-FLEX3D, PHT-7000 (2012), 28 descendants of its own
- K122606: PHT-6500; PHT-60CFO; Pax-I3D (2012), 27 descendants of its own
- K152106: Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart (2015), 25 descendants of its own

## Indications for use
EPX-lmpla is a computed tomography x-ray system that acquires a 360° rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.

Source page: https://510kreport.com/device/K070658
Methodology: https://510kreport.com/methodology