K152361 is an FDA 510(k) clearance for the OptiOne Single-Head Contrast Delivery System with Pedestal. This device is classified as a Injector, Contrast Medium, Automatic (Class II - Special Controls, product code IZQ).
Submitted by Liebel-Flarsheim Company, LLC (Cincinnati, US). The FDA issued a Cleared decision on January 14, 2016, 147 days after receiving the submission on August 20, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1650.
| 510(k) Number | K152361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2015 |
| Decision Date | January 14, 2016 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | IZQ - Injector, Contrast Medium, Automatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1650 |