# K093683: Orthopantomograph OP300

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentarium Dental, Palodex Group OY
- Decided: Oct 6, 2010 after 310 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: 5 generations back to K973598 (1997). 13 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 35 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 1.
- K073350: Scanora 3D, Soredex Palodex Group OY (2007) Summary page 1.
- K073696: Veraviewepocs, J. Morita USA, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K180947: Orthopantomograph OP 3D (2018), 2 descendants of its own

## Indications for use
The Orthopantomograph® 0P300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examinations 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 must only be operated and used by dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K093683
Methodology: https://510kreport.com/methodology