# K150506: ELIAN Digital Diagnostic X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Osko, Inc.
- Decided: Apr 8, 2015 after 41 days
- Product code: KPR (System, X-Ray, Stationary)
- 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 K981556 (1998). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090238: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems, Sedecal., Sa. (2009) Summary page 4.
- K031447: Canon, Digital Radiography, Model Cxdi-50G, Canon, Inc. (2003) Summary page 4.

## Indications for use
The ELIAN diagnostic X-ray system is intended for use on adult and pediatric patients for taking diagnostics radiographic exposure of all body parts and operated by a qualified/trained doctor or technician. NOT intended for Mammography use.

Source page: https://510kreport.com/device/K150506
Methodology: https://510kreport.com/methodology