# K212279: Digital Intraoral X-ray Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Iray Technology Taicang, Ltd.
- Decided: Oct 7, 2021 after 79 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 7.

## Indications for use
Digital intraoral X-ray Imaging System, models i-Sensor H1 and i-Sensor H2, are used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination, the diagnosis of structural diseases of teeth, jaws and mouth. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications. This device is suitable for providing dental radiography imaging for both adult and pediatric.

Source page: https://510kreport.com/device/K212279
Methodology: https://510kreport.com/methodology