# K152489: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray

- Pathway: 510(k) (Traditional)
- Applicant: Panoramic Corp.
- Decided: Feb 4, 2016 after 156 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- 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
Longest line of descent: 8 generations back to K973598 (1997). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122199: PREXION3D Eclipse, The Yoshida Dental Mfg. Co., Ltd. (2013) Summary page 4.

## Most influential descendants
- K210820: EAGLE EDGE AXR90 and AXR120 (2021), 1 descendant of its own
- K223816: Dental CT Scanner AXR (2023), 0 descendants of its own

## Indications for use
ENCOMPASS Eagle 3D is intended to acquire two-dimensional digital panoramic and cephalometric radiographies, and multi-field of view 3D computed tomography images of dento-maxillo-facial region for the purpose of advanced diagnosis at the direction of qualified dental healthcare professionals

Source page: https://510kreport.com/device/K152489
Methodology: https://510kreport.com/methodology