# K230811: Digital Intraoral X-Ray Sensor

- Pathway: 510(k) (Special)
- Applicant: Iray Imaging Technology (Haining) Limited
- Decided: Apr 21, 2023 after 28 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
Longest line of descent: 5 generations back to K933455 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210312: PlutoX Digital Intraoral X-Ray Imaging System, Iray Technology Taicang, Ltd. (2021) Summary page 5.

## Indications for use
Used in conjunction with a pulsed dental X-ray machine, the CS 6200 is intended for medical institutions to perform static digital X-ray imaging facilitating the diagnosis of the teeth, jaw, mouth, and other structural diseases.

Source page: https://510kreport.com/device/K230811
Methodology: https://510kreport.com/methodology