The following data is part of a premarket notification filed by Canon Inc. with the FDA for Intelligent Nr.
Device ID | K212269 |
510k Number | K212269 |
Device Name: | Intelligent NR |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-07-20 |
Decision Date | 2021-09-17 |