K150506 is an FDA 510(k) clearance for the ELIAN Digital Diagnostic X-ray System. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Osko, Inc. (Miami, US). The FDA issued a Cleared decision on April 8, 2015, 41 days after receiving the submission on February 26, 2015.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K150506 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2015 |
| Decision Date | April 08, 2015 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR - System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |