The following data is part of a premarket notification filed by Omega Medical Imaging, Llc with the FDA for Cs-series-fp Radiographic / Fluoroscopic Systems With Optional Ca-100s / Fluoroshield™ (roi Assembly).
| Device ID | K191713 |
| 510k Number | K191713 |
| Device Name: | CS-series-FP Radiographic / Fluoroscopic Systems With Optional CA-100S / FluoroShield™ (ROI Assembly) |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Omega Medical Imaging, LLC 3400 St. Johns Parkway, Suite 1020 Sanford, FL 32771 |
| Contact | John Newman |
| Correspondent | John Newman Omega Medical Imaging, LLC 3400 St. Johns Parkway, Suite 1020 Sanford, FL 32771 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-26 |
| Decision Date | 2019-10-04 |