The following data is part of a premarket notification filed by Virtual Imaging, Inc. with the FDA for Canon Digital Fluoroscopy And Radiography, Model Cxdi-50rf.
| Device ID | K092439 |
| 510k Number | K092439 |
| Device Name: | CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | VIRTUAL IMAGING, INC. 333 MILFORD RD. Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm VIRTUAL IMAGING, INC. 333 MILFORD RD. Deerfield, IL 60015 |
| 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 | 2009-08-10 |
| Decision Date | 2009-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04960999810911 | K092439 | 000 |