# K200688: hyperion X5, NewTom GO, X-RADiUS COMPACT

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: Apr 9, 2020 after 24 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: 1 generation back to K190496 (2019). 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)
- K190496: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS, Cefla S.C. (2019) Summary page 5.

## Most influential descendants
- K252353: myray ProXIma X6 (2026), 0 descendants of its own

## Indications for use
hyperion X5 is an extraoral X-ray system for digital panoramic exams, tele-X-rays and tomographies, intended to: 1. produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity: 2. produce X-ray images of dental arches, cranium parts, and carpus in support of cephalometric examinations, if equipped with tele-X-ray arm (CEPH); 3. 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, if equipped with CBCT option. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

Source page: https://510kreport.com/device/K200688
Methodology: https://510kreport.com/methodology