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 |