The following data is part of a premarket notification filed by Canon Inc. with the FDA for Digital Radiography Cxdi-pro, D1.
Device ID | K212553 |
510k Number | K212553 |
Device Name: | DIGITAL RADIOGRAPHY CXDI-Pro, D1 |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | Canon Inc. 9-1 Imaikami-cho, Nakahara-ku Kawasaki, JP 211-8501 |
Contact | Akira Hirai |
Correspondent | Gregory Woodard Ken Block Consulting 800 East Campbell Road, Suite 202 Richardson, TX 75081 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-13 |
Decision Date | 2021-09-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04549292200935 | K212553 | 000 |