# K081847: Picasso Master, Ect and Master 3D

- Pathway: 510(k) (Traditional)
- Applicant: E-Woo Technology
- Decided: Aug 21, 2008 after 52 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
Longest line of descent: 3 generations back to K973598 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070658: Dental Digital Panoramic/3D Imaging System, E-Woo Technology (2007) Summary page 1.
- K061284: I-Cat Scanner, Imaging Sciences Intl., Inc. (2006) Summary page 1.

## Indications for use
"Picasso-Master also known as ECT and Master3D" is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures for surgical planning of oral and maxillofacial area by acquiring 3600 rotational image sequences of the head and neck areas, including the ENT and dentomaxillofacial area. The device is operated and used by physicians, dentists, and x-ray technicians.

Source page: https://510kreport.com/device/K081847
Methodology: https://510kreport.com/methodology