The following data is part of a premarket notification filed by Canon, Inc. with the FDA for Enhanced Feature Software Pack Cxdi Series.
| Device ID | K190368 |
| 510k Number | K190368 |
| Device Name: | Enhanced Feature Software Pack 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 | Yamazaki Tatsuya |
| Correspondent | Katie Reneson 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 | 2019-02-15 |
| Decision Date | 2019-03-13 |
| Summary: | summary |