# K101661: Myray Hyperion

- Pathway: 510(k) (Traditional)
- Applicant: Cefla Dental Group
- Decided: Sep 16, 2010 after 94 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: 3 generations back to K972312 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043612: Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D, Instrumentarium Corp. Imaging Division (2005) Summary page 1.
- K033073: Orthophos XG DS/Ceph, Sirona Dental Systems GmbH (2003) Summary page 1.
- K032355: Orthoralix 9200 Dde, Orthoralix 9200 Dde Plus Ceph, Models 5105 0161WW, 5105 0181WW, Dentsply Gendex (2003) Summary page 1.

## Indications for use
The Cefla MyRay Hyperion is indicated for use in producing panoramic X-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures.

Source page: https://510kreport.com/device/K101661
Methodology: https://510kreport.com/methodology