# K972249: Orthophos Plus and Orthophos Plus/CD

- Pathway: 510(k) (Traditional)
- Applicant: Pelton & Crane Co.
- Decided: Sep 12, 1997 after 88 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 K895467 (1989). 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)
- K895467: Orthophos and Orthophos C, Siemens Medical Solutions USA, Inc. (1989) Summary page 2.

## Indications for use
The Orthophos Plus and Orthophos Plus/CD are intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The X-ray source is located outside the mouth. The system provides for panoramic imaging of the entire maxillofacial region as well as transverse slice imaging of the maxillary and mandibular regions.

Source page: https://510kreport.com/device/K972249
Methodology: https://510kreport.com/methodology