# K122018: OP300

- Pathway: 510(k) (Special)
- Applicant: Palodex Group OY
- Decided: Dec 10, 2012 after 153 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). 14 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093683: Orthopantomograph OP300, Instrumentarium Dental, Palodex Group OY (2010) Summary page 2.

## Most influential descendants
- K133544: OP300 (2014), 7 descendants of its own
- K180947: Orthopantomograph OP 3D (2018), 2 descendants of its own
- K163423: Orthopantomograph OP300 (2017), 2 descendants of its own
- K230505: Orthopantomograph™ OP 3D LX (2023), 1 descendant of its own
- K171012: Veraview X800 (2017), 1 descendant of its own

## Indications for use
The 0P300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examination of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

Source page: https://510kreport.com/device/K122018
Methodology: https://510kreport.com/methodology