# K073350: Scanora 3D

- Pathway: 510(k) (Traditional)
- Applicant: Soredex Palodex Group OY
- Decided: Dec 19, 2007 after 20 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K973598 (1997). 7 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060328: Planmeca Promax 3D, Planmeca Oy (2006) Summary page 2.
- K061284: I-Cat Scanner, Imaging Sciences Intl., Inc. (2006) Summary page 2.

## Most influential descendants
- K093683: Orthopantomograph OP300 (2010), 21 descendants of its own
- K111231: Panoura 18S (2011), 11 descendants of its own
- K122018: OP300 (2012), 8 descendants of its own
- K133544: OP300 (2014), 7 descendants of its own
- K122199: PREXION3D Eclipse (2013), 6 descendants of its own

## Indications for use
Scanora 3D is a dental cone beam computed tomography x-ray system intended to image teeth, jaw and TMJ areas of the skull. 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 dentists and other qualified professionals.

Source page: https://510kreport.com/device/K073350
Methodology: https://510kreport.com/methodology