The following data is part of a premarket notification filed by Virtual Imaging, Inc. with the FDA for Fluoropro Rf Digital Imaging System.
| Device ID | K070390 |
| 510k Number | K070390 |
| Device Name: | FLUOROPRO RF DIGITAL IMAGING SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | VIRTUAL IMAGING, INC. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm VIRTUAL IMAGING, INC. PO BOX 7007 Deerfield, IL 60015 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-09 |
| Decision Date | 2007-04-05 |
| Summary: | summary |