# K152162: Myray- HYPERION X5

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: Dec 24, 2015 after 143 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: 1 generation back to K123381 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123381: Hyperion X9, Cefla S.C. (2013) Summary page 4.

## Most influential descendants
- K161900: Hyperion X5 (2016), 0 descendants of its own

## Indications for use
HYPERION X5 is an extraoral X-ray system for digital panoramic X-rays suitable for production of orthopanoramic images of the maxillofacial region, diagnostic examination of the dentition (teeth), arches and other structures of the oral cavity.

Source page: https://510kreport.com/device/K152162
Methodology: https://510kreport.com/methodology