The following data is part of a premarket notification filed by Communications & Power Industries Canada, Inc. with the FDA for Cpi Rad Vision, Model Vzw2944xx-yy.
Device ID | K083224 |
510k Number | K083224 |
Device Name: | CPI RAD VISION, MODEL VZW2944XX-YY |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
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 | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-03 |
Decision Date | 2009-03-24 |
Summary: | summary |