The following data is part of a premarket notification filed by Atomic Energy Of Canada with the FDA for Therac 25 Linear Accelerator.
Device ID | K837152 |
510k Number | K837152 |
Device Name: | THERAC 25 LINEAR ACCELERATOR |
Classification | Couch, Radiation Therapy, Powered |
Applicant | ATOMIC ENERGY OF CANADA 413 MARCH ROAD P.O. BOX 13140 Kanata, Ontario, CA K2k 2b7 |
Product Code | JAI |
CFR Regulation Number | 892.5770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-28 |
Decision Date | 1983-03-22 |