# K170813: Orthopantomograph OP 3D

- Pathway: 510(k) (Traditional)
- Applicant: Palodex Group OY
- Decided: Apr 7, 2017 after 21 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). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133544: OP300, Palodex Group OY (2014) Summary page 4.

## Recalls of this device
- Dec 31, 2018 · Class II · Z-1101-2019: ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1

## Indications for use
ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device to take panoramic and 3D images of the cranio-maxillofacial complex for use in diagnostic support. ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.

Source page: https://510kreport.com/device/K170813
Methodology: https://510kreport.com/methodology