# K082410: MASTER3DS

- Pathway: 510(k) (Traditional)
- Applicant: E-Woo Technology
- Decided: Oct 31, 2008 after 71 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: 3 generations back to K973598 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061284: I-Cat Scanner, Imaging Sciences Intl., Inc. (2006) Summary page 1.

## Indications for use
The Master3DS is a X-ray, tomography, computed, dental that provides 3D imaging of dental and maxillofacial for diagnosis and treatment planning.

Source page: https://510kreport.com/device/K082410
Methodology: https://510kreport.com/methodology