# K110839: Scanora 3D

- Pathway: 510(k) (Traditional)
- Applicant: Soredex Palodex Group OY
- Decided: Jun 30, 2011 after 97 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: 5 generations back to K973598 (1997). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073350: Scanora 3D, Soredex Palodex Group OY (2007) Summary page 2.
- K073695: 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1F8/F17, J. Morita USA, Inc. (2008) Summary page 2.

## Most influential descendants
- K163423: Orthopantomograph OP300 (2017), 2 descendants of its own
- K230505: Orthopantomograph™ OP 3D LX (2023), 1 descendant of its own
- K241249: Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) (2024), 0 descendants of its own
- K130297: Scanora 3DX (2013), 0 descendants of its own

## Indications for use
Scanora 3D 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/K110839
Methodology: https://510kreport.com/methodology