The following data is part of a premarket notification filed by Canon, Inc with the FDA for Scatter Correction For Cxdi Series.
| Device ID | K153312 |
| 510k Number | K153312 |
| Device Name: | SCATTER CORRECTION FOR CXDI SERIES |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CANON, INC 30-2 SHIMOMARUKO, 3-CHROME, OHTA-KU Tokyo, JP 146-8501 |
| 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 | 2015-11-17 |
| Decision Date | 2016-06-28 |
| Summary: | summary |