# K252353: myray ProXIma X6

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: Mar 10, 2026 after 224 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 K190496 (2019). 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)
- K200688: hyperion X5, NewTom GO, X-RADiUS COMPACT, Cefla S.C. (2020) Summary page 6.

## Indications for use
ProXIma X6 is an extra-oral X-ray equipment for digital panoramic, tomographic and cephalometric Xrays exams, indicated for the following: (I) production of orthopanoramic images of the maxillofacial area, diagnostic dental exams on teeth, dental arches and other structures of the oral cavity; (II) Production of X-ray images of the dental arches, parts of the cranium and of the carpus in support of cephalometric examination, where the configuration includes the CEPH arm; (III) production of tomographic images of the structures of the maxillofacial area and oral cavity for diagnostic dental exams on teeth, dental arches, the structures of the oral cavity, where the configuration includes the 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/K252353
Methodology: https://510kreport.com/methodology