# K122199: PREXION3D Eclipse

- Pathway: 510(k) (Traditional)
- Applicant: The Yoshida Dental Mfg. Co., Ltd.
- Decided: Apr 18, 2013 after 268 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: 7 generations back to K973598 (1997). 19 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063622: Finecube Dental CT, The Yoshida Dental Mfg. Co., Ltd. (2007) Summary page 2.
- K103659: CS 9300, CS 9300C, Trophy (2011) Summary page 2.
- K111231: Panoura 18S, The Yoshida Dental Mfg. Co., Ltd. (2011) Summary page 2.

## Most influential descendants
- K161881: PreXion3D Excelsior (2016), 2 descendants of its own
- K152489: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray (2016), 2 descendants of its own
- K210820: EAGLE EDGE AXR90 and AXR120 (2021), 1 descendant of its own
- K173878: PreXion3D Excelsior (2018), 1 descendant of its own
- K223816: Dental CT Scanner AXR (2023), 0 descendants of its own

## Indications for use
PREXION3D ECLIPSE is intended to produce two-dimensional digital panoramic and cephalometric images, and three-dimensional digital x-ray images of the dento-maxillo-facial region at the direction of healthcare professionals as diagnostic support.

Source page: https://510kreport.com/device/K122199
Methodology: https://510kreport.com/methodology