# K122806: Image Works Panoura

- Pathway: 510(k) (Traditional)
- Applicant: Mic International
- Decided: Mar 8, 2013 after 176 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: 7 generations back to K973598 (1997). 15 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111231: Panoura 18S, The Yoshida Dental Mfg. Co., Ltd. (2011) Summary page 2.
- K093683: Orthopantomograph OP300, Instrumentarium Dental, Palodex Group OY (2010) Summary page 2.

## Most influential descendants
- K182198: Panoura X-ERA PF/NF/MF (2019), 1 descendant of its own
- K222666: X-View 3D Pan/X-View 2D Pan (2023), 0 descendants of its own

## Indications for use
The IMAGEWORKS PANOURA dental panoramic and cephalometric 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 examined volume for the reconstruction of 3D view. The device must only be operated and used by dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K122806
Methodology: https://510kreport.com/methodology