# K163423: Orthopantomograph OP300

- Pathway: 510(k) (Traditional)
- Applicant: Palodex Group OY
- Decided: Aug 31, 2017 after 268 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K973598 (1997). 18 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 21 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 4.
- K133544: OP300, Palodex Group OY (2014) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Oct 28, 2021 · Class II · Z-2413-2024: It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria (repe

## Indications for use
The Orthopantomograph OP300 panoramic, cephalometric and cone beam computed tomography x-ray device is intended to image the head and neck areas for diagnostic support. This includes temporomandibular Joints (TMJs) and dentomaxillofacial areas, and with the 13x15 cm field of view (FOV) this additionally includes the ear, nose and throat (ENT) regions. The x-ray device produces conventional 2D x-ray images and x-ray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.

Source page: https://510kreport.com/device/K163423
Methodology: https://510kreport.com/methodology