# K113497: Hyperion

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C. Cefla Dental Group
- Decided: Jan 17, 2012 after 53 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K133797: Qmaster-H/Revo (2014), 0 descendants of its own

## Indications for use
The hyperion is a digital panoramic and cephalometric extra-oral X-ray system, indicated for use in: (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and (ii) producing radiographs of the jaws and parts of the skull, for the purpose of cephalometric examination if equipped with CEPH arm.

Source page: https://510kreport.com/device/K113497
Methodology: https://510kreport.com/methodology