The following data is part of a premarket notification filed by Canon, Inc with the FDA for Digital Radiography Cxdi-410c Wireless.
Device ID | K171270 |
510k Number | K171270 |
Device Name: | DIGITAL RADIOGRAPHY CXDI-410C WIRELESS |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | Canon, Inc 9-1, Imaikami-cho, Nakahara-ku Kawasaki, JP |
Contact | Shinji Mori |
Correspondent | Diane Rutherford Ken Block Consulting 1201 Richardson Drive, Suite 160 Richardson, TX 75080 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-01 |
Decision Date | 2017-11-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04549292099478 | K171270 | 000 |