# K090991: Computed Tomography X-Ray System, Model Picasso-Duo

- Pathway: 510(k) (Traditional)
- Applicant: E-Woo Technology
- Decided: Oct 9, 2009 after 185 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 K973642 (1997). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082350: PAX-500, VATECH Co., Ltd. (2008) Summary page 1.
- K070658: Dental Digital Panoramic/3D Imaging System, E-Woo Technology (2007) Summary page 1.

## Most influential descendants
- K102196: Computed Tomography X-Ray System (2011), 2 descendants of its own
- K132983: Ton-95LH, Pax-I3D Ortho (2014), 1 descendant of its own
- K160882: PaX-i3D Green Premium (Model: PCT-90LH) (2016), 0 descendants of its own

## Indications for use
The Picasso-Duo is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images(optionally with panoramic) for dental examination and diagnosis of diseases of the teeth, jaw and oral structure by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

Source page: https://510kreport.com/device/K090991
Methodology: https://510kreport.com/methodology