The following data is part of a premarket notification filed by Portavision Medical Llc with the FDA for Mobileray Pulse Se Digital Imaging System.
| Device ID | K191503 |
| 510k Number | K191503 |
| Device Name: | MobileRay Pulse SE Digital Imaging System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Portavision Medical LLC 800 Central Avenue Jefferson, LA 70121 |
| Contact | Terry Ancar |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Court Naples, FL 34114 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-06 |
| Decision Date | 2019-09-04 |
| Summary: | summary |