The following data is part of a premarket notification filed by Communications & Power Industries Canada, Inc. with the FDA for Cpivision Digital Imaging System.
| Device ID | K061173 |
| 510k Number | K061173 |
| Device Name: | CPIVISION DIGITAL IMAGING SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. 45 RIVER DRIVE Georgetown,ontario, CA L7g 2j4 |
| Contact | Norm Morikawa |
| Correspondent | Norm Morikawa COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. 45 RIVER DRIVE Georgetown,ontario, CA L7g 2j4 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-27 |
| Decision Date | 2006-06-09 |
| Summary: | summary |