# K223780: Lumos 3DX

- Pathway: 510(k) (Traditional)
- Applicant: 3Dio
- Decided: Jul 6, 2023 after 202 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: 7 generations back to K935046 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211014: Portray, Surround Medical Systems (2021) Summary page 4.

## Indications for use
The Lumos 3DX ™ System is an extraoral X-ray source (intraoral X-ray detection) dental X-ray system for producing diagnostic dental radiographs of the teeth, jaw, and other oral structures. The system provides 3D imaging for diagnostic purposes via tomosynthesis. For use on adult patients only.

Source page: https://510kreport.com/device/K223780
Methodology: https://510kreport.com/methodology