# K081088: Myray Skyview

- Pathway: 510(k) (Abbreviated)
- Applicant: Cefla S.C.
- Decided: Nov 6, 2008 after 204 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
This 3-D X-ray system, aka CBCT (cone beam computed tomography) is used to perform radiographic examination of the oral and maxillofacial structure. It is intended to be used in both radiology centers and average-large dental offices, specialized in implantology.

Source page: https://510kreport.com/device/K081088
Methodology: https://510kreport.com/methodology