# K041580: Imagerayi

- Pathway: 510(k) (Traditional)
- Applicant: Henry Schein, Inc.
- Decided: Jun 29, 2004 after 15 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
The digital x-ray sensor system, lmageRAYi, of Dentrix Dental Systems, Inc. which is a subsidiary of Henry Schein Company, Inc., and its related components are used to provide instant x-ray images of human oral tissue (dentin). The digital x-ray sensor system, ImageRAYi, replaces standard intraoral x-ray film and uses the same x-ray source.

Source page: https://510kreport.com/device/K041580
Methodology: https://510kreport.com/methodology