# K201247: Intraoral Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Dentium Co., Ltd (Ict Branch)
- Decided: Jun 10, 2020 after 30 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 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)
- K143000: RIS500, Ray Co., Ltd. (2015) Summary page 4.

## Indications for use
Intra Oral Sensor (model: IOX 1 / IOX 2) is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, views and manipulated for diagnostic use by dentists.

Source page: https://510kreport.com/device/K201247
Methodology: https://510kreport.com/methodology