The following data is part of a premarket notification filed by Omega Medical Imaging, Llc with the FDA for Cs-series-fp With Mx Cfp 3131 Or Mx Cfp 2222 Option Radiographic/fluoroscopy System.
| Device ID | K171755 |
| 510k Number | K171755 |
| Device Name: | CS-series-FP With MX CFP 3131 Or MX CFP 2222 Option Radiographic/Fluoroscopy System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Omega Medical Imaging, LLC 675 Hickman Circle Sanford, FL 32771 |
| Contact | John Newman |
| Correspondent | John Newman Omega Medical Imaging, LLC 675 Hickman Circle Sanford, FL 32771 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-13 |
| Decision Date | 2018-02-09 |
| Summary: | summary |