# K161900: Hyperion X5

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: Dec 9, 2016 after 151 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K123381 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
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.
- K152162: Myray- HYPERION X5, Cefla S.C. (2015) Summary page 4.

## Indications for use
The Hyperion X5 device, 3D version machine, is an image reproducer suitable for expert professionals, which allows to obtain dental images in a simple and automatic way. The image is acquired by means of an X-ray detector and a constant potential X-ray source, powered by a high-voltage and high-frequency generator. The image is then transmitted to a computer in real time. The Hyperion X5 device, 3D version machine, intended to: I. produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity: II. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones. The system performs tomographic exams with the acquisition of X-ray images through a rotating sequence and the reconstruction of a three-dimensional matrix of the examined volume, thus producing two- and three-dimensional views of the volume itself. This technique is known as CBCT.

Source page: https://510kreport.com/device/K161900
Methodology: https://510kreport.com/methodology