K123508 is an FDA 510(k) clearance for the TRINIAS. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Shimadzu Corporation (Kyoto, JP). The FDA issued a Cleared decision on February 26, 2014, 470 days after receiving the submission on November 13, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K123508 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2012 |
| Decision Date | February 26, 2014 |
| Days to Decision | 470 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | OWB - Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |