# K983057: Orthophos 5/Plus/CD

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Oct 22, 1998 after 51 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
No predicates in its family tree.
23 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013650: Orthophos DS/DC Ceph, Orthophos 5/Plus/CD (2001), 16 descendants of its own
- K033073: Orthophos XG DS/Ceph (2003), 15 descendants of its own
- K103711: Orthophos XG 3D / Ceph (2011), 7 descendants of its own
- K150217: Orthophos SL (2015), 5 descendants of its own
- K122918: Rayscan a-Expert (2013), 5 descendants of its own

## Indications for use
The Orthopllos 5/PLUS/CD is an extraoral X-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The system allows for panoramic tomograpllic imaging, teleradiography, and transverse slice imaging.

Source page: https://510kreport.com/device/K983057
Methodology: https://510kreport.com/methodology