# K211688: DC-Air and Athlos-1 and Athlos-Air

- Pathway: 510(k) (Traditional)
- Applicant: Athlos OY
- Decided: Jul 22, 2021 after 50 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
DC-Air™, Athlos-1, Athlos-Air are intended to be used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw, and oral structures. DC-Air™, Athlos-1, Athlos-Air are suitable for general populations.

Source page: https://510kreport.com/device/K211688
Methodology: https://510kreport.com/methodology