The following data is part of a premarket notification filed by Virtual Imaging, Inc. with the FDA for Radpro Ion.
| Device ID | K083725 |
| 510k Number | K083725 |
| Device Name: | RADPRO ION |
| Classification | Interventional Fluoroscopic X-ray System |
| 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 | 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 | 2008-12-15 |
| Decision Date | 2009-01-22 |
| Summary: | summary |