The following data is part of a premarket notification filed by Virtual Imaging, Inc. with the FDA for Canon, Model Urs-50rf.
| Device ID | K093688 |
| 510k Number | K093688 |
| Device Name: | CANON, MODEL URS-50RF |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | VIRTUAL IMAGING, INC. 8726 FERRARA CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm VIRTUAL IMAGING, INC. 8726 FERRARA CT Naples, FL 34114 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-30 |
| Decision Date | 2010-02-04 |
| Summary: | summary |