# K111231: Panoura 18S

- Pathway: 510(k) (Traditional)
- Applicant: The Yoshida Dental Mfg. Co., Ltd.
- Decided: Jul 13, 2011 after 72 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: 6 generations back to K973598 (1997). 14 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 26 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
- K122199: PREXION3D Eclipse (2013), 6 descendants of its own
- K161881: PreXion3D Excelsior (2016), 2 descendants of its own
- K152489: ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray (2016), 2 descendants of its own
- K122806: Image Works Panoura (2013), 2 descendants of its own
- K210820: EAGLE EDGE AXR90 and AXR120 (2021), 1 descendant of its own

## Indications for use
The PANOURA 18S 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. The device must only be operated and used by dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K111231
Methodology: https://510kreport.com/methodology