K171755 is an FDA 510(k) clearance for the CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Omega Medical Imaging, LLC (Sanford, US). The FDA issued a Cleared decision on February 9, 2018, 241 days after receiving the submission on June 13, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K171755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2017 |
| Decision Date | February 09, 2018 |
| Days to Decision | 241 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB - Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |