# K965072: Panoura Ultra Pan and Panoura Ultra Pan/Ceph Panoramic/Cephalometric X-Ray Unit

- Pathway: 510(k) (Traditional)
- Applicant: Kaycor Intl., Ltd.
- Decided: Jan 27, 1997 after 39 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- 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: 1 generation back to K811210 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811210: Yoshida-Panoura 10, Kaycor Intl., Ltd. (1981) Summary page 1.

## Indications for use
The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph will be marketed for diagnostic radiographic use in dental, oral surgery, and orthodontic practices, and in other medical facilities where these types of dental radiographs are routinely taken. These uses are typical of the predicate devices in the Panoura-10 series.

Source page: https://510kreport.com/device/K965072
Methodology: https://510kreport.com/methodology