# K143000: RIS500

- Pathway: 510(k) (Traditional)
- Applicant: Ray Co., Ltd.
- Decided: Jan 23, 2015 after 98 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.
2 later devices descend from it; 2 cite it directly.
0 of 10 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 6.
- K090526: Medical Image Processing Unit, Model Ezsensor, E-Woo Technology (2009) Summary page 6.

## Most influential descendants
- K201247: Intraoral Sensor (2020), 0 descendants of its own
- K153710: Tuxedo Digital Dental Sensor (2016), 0 descendants of its own

## Indications for use
This system 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/K143000
Methodology: https://510kreport.com/methodology