The following data is part of a premarket notification filed by Imagexray, Llc with the FDA for Vfss Pro Mobile Digital Imaging System.
| Device ID | K212523 |
| 510k Number | K212523 |
| Device Name: | VFSS Pro Mobile Digital Imaging System |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | IMAGExRAY, LLC 160 Park Avenue Nutley, NJ 07110 |
| Contact | Gary Korkola |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| Subsequent Product Code | QHY |
| Subsequent Product Code | RCC |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-11 |
| Decision Date | 2021-11-05 |