K191713 is an FDA 510(k) clearance for the CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly). This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Omega Medical Imaging, LLC (Sanford, US). The FDA issued a Cleared decision on October 4, 2019, 100 days after receiving the submission on June 26, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K191713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2019 |
| Decision Date | October 04, 2019 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAA - System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |