# K052422: The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)

- Pathway: 510(k) (Special)
- Applicant: Flow X-Ray Corp.
- Decided: Sep 27, 2005 after 25 days
- Product code: EAP (Unit, X-Ray, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.1810
- 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 K896024 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896024: MDT/Castle Model HDX Dental X-Ray Machine, Mdt Diagnostic Co. (1990) Summary page 1.

## Indications for use
The EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile) are intended to be used only for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system.

Source page: https://510kreport.com/device/K052422
Methodology: https://510kreport.com/methodology