The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Inc., Digital Radiography, Model Cxdi-40c.
Device ID | K031633 |
510k Number | K031633 |
Device Name: | CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Contact | Sheila Driscoll |
Correspondent | Pamela Gwynn UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-05-27 |
Decision Date | 2003-06-11 |
Summary: | summary |