# K130297: Scanora 3DX

- Pathway: 510(k) (Special)
- Applicant: Palodex Group OY
- Decided: May 29, 2013 after 112 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: 6 generations back to K973598 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110839: Scanora 3D, Soredex Palodex Group OY (2011) Summary page 3.

## Indications for use
Scanora 3Dx is a Cone Beam 3D x-ray system for imaging the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. Dedicated panoramic imaging is an option A flat panel detector is used to acquire 3D images and an optional CCD sensor to acquire panoramic images- The device is operated and used by qualified healthcare professionals.

Source page: https://510kreport.com/device/K130297
Methodology: https://510kreport.com/methodology