The following data is part of a premarket notification filed by Canon Inc. with the FDA for Canon, Digital Radiography, Model Cxdi-50g.
Device ID | K031447 |
510k Number | K031447 |
Device Name: | CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | CANON INC. ONE CANON PLAZA Lake Success, NY 11042 |
Contact | Sheila Driscoll |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-05-07 |
Decision Date | 2003-05-21 |
Summary: | summary |