# K202369: RXS 1000

- Pathway: 510(k) (Traditional)
- Applicant: Rolence Enterprise, Inc.
- Decided: Sep 15, 2021 after 392 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: 7 generations back to K933455 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163282: Apex Dental Sensors, Masterlink, LLC (2017) Summary page 4.

## Indications for use
The RXS 1000 is an Intraoral Digital X-ray Sensor and is intended to be used by dentists and dental technicians diagnostic diseases of the teeth, jaw and oral structures. Its use is intended for adult subjects.

Source page: https://510kreport.com/device/K202369
Methodology: https://510kreport.com/methodology