# K140060: Digital Dental Intra Oral Sensor, Hdi 2000, Hdi 2000A

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: May 13, 2014 after 123 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: 6 generations back to K933455 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121132: Ezsensor P Digital Intraoral Sensor, Humanray Co,Ltd (2012) Summary page 3.

## Indications for use
HDI 2000 / HDI 2000A, an Intra-Oral Imaging System, is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

Source page: https://510kreport.com/device/K140060
Methodology: https://510kreport.com/methodology