The following data is part of a premarket notification filed by Canon, Inc.-medical Equipment Group with the FDA for Flat Panel Detector.
| Device ID | K111824 |
| 510k Number | K111824 |
| Device Name: | FLAT PANEL DETECTOR |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CANON, INC.-MEDICAL EQUIPMENT GROUP 1201 RICHARDSON DRIVE SUITE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford CANON, INC.-MEDICAL EQUIPMENT GROUP 1201 RICHARDSON DRIVE SUITE 280 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 | 2011-06-28 |
| Decision Date | 2012-04-23 |