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.
Device ID | K853984 |
510k Number | K853984 |
Device Name: | CANON X-RAY IMAGE DISTRIBUTOR |
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 | 1985-09-27 |
Decision Date | 1985-10-16 |