The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon X-ray Image Distributor Cxi-3-3d.
| Device ID | K871119 |
| 510k Number | K871119 |
| Device Name: | CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Contact | Tamada |
| Correspondent | Tamada CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-19 |
| Decision Date | 1987-03-31 |