# K181636: Aurora

- Pathway: 510(k) (Traditional)
- Applicant: Sodium Systems, LLC
- Decided: Jul 20, 2018 after 29 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 4.

## Indications for use
Aurora is an intra-oral sensor used by dental professionals for the purpose of acquiring x-ray images to be used for the diagnosis of diseases of the mouth and for evaluating general dental health.

Source page: https://510kreport.com/device/K181636
Methodology: https://510kreport.com/methodology