The following data is part of a premarket notification filed by Canon, Inc. - Medical Equpment Group with the FDA for Flat Panel Detector.
| Device ID | K121444 |
| 510k Number | K121444 |
| Device Name: | FLAT PANEL DETECTOR |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | CANON, INC. - MEDICAL EQUPMENT GROUP 1201 RICHARDSON DR, STE 280 Richardson, TX 75080 |
| Contact | Diane Rutherford |
| Correspondent | Diane Rutherford CANON, INC. - MEDICAL EQUPMENT GROUP 1201 RICHARDSON DR, STE 280 Richardson, TX 75080 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-15 |
| Decision Date | 2012-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04549292075182 | K121444 | 000 |