# K200284: R-Sensor, R-Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Remedi Co., Ltd.
- Decided: Feb 28, 2020 after 23 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: 6 generations back to K933455 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151926: QuickRay HD Intraoral Sensor, Denterprise International, Inc. (2015) Summary page 5.

## Indications for use
R-Sensor is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.

Source page: https://510kreport.com/device/K200284
Methodology: https://510kreport.com/methodology