The following data is part of a premarket notification filed by Omega Medical Imaging, Llc with the FDA for Cs-series-fp With Optional Roi Accessory Ca-100s.
| Device ID | K182834 |
| 510k Number | K182834 |
| Device Name: | CS-series-FP With Optional ROI Accessory CA-100S |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | Omega Medical Imaging, LLC 675 Hickman Circle Sanford, FL 32771 |
| Contact | John Newman Newman |
| Correspondent | John Newman Omega Medical Imaging, LLC 675 Hickman Circle 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 | 2018-10-09 |
| Decision Date | 2019-03-29 |