The following data is part of a premarket notification filed by Canon, Inc. – Medical Equipment Group with the FDA for Csx-30 Flat Panel Detector.
| Device ID | K162909 |
| 510k Number | K162909 |
| Device Name: | CSX-30 Flat Panel Detector |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Canon, Inc. – Medical Equipment Group 9-1, Imaikami-cho, Nakahara-ku Kawasaki, JP 211-8501 |
| Contact | Shinji Mori |
| Correspondent | Diane Rutherford Ken Block Consulting 1201 Richardson Drive 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 | 2016-10-17 |
| Decision Date | 2017-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04549292075175 | K162909 | 000 |