# K140056: Digital Dental Intra Oral Sensor; Hdi 1000, Hdi 1000A

- 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: 4 generations back to K933455 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090526: Medical Image Processing Unit, Model Ezsensor, E-Woo Technology (2009) Summary page 1.

## Indications for use
HDI 1000 /HDI 1000A, an Intra-oral Imaging System, is used to collect dental x-rays 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/K140056
Methodology: https://510kreport.com/methodology