The following data is part of a premarket notification filed by Atomic Energy Of Canada with the FDA for Linear Accelerator Therac 25.
Device ID | K837347 |
510k Number | K837347 |
Device Name: | LINEAR ACCELERATOR THERAC 25 |
Classification | Accelerator, Linear, Medical |
Applicant | ATOMIC ENERGY OF CANADA 413 MARCH ROAD P.O. BOX 13140 Kanata, Ontario, CA K2k 2b7 |
Contact | Theratronics Intl |
Correspondent | Theratronics Intl ATOMIC ENERGY OF CANADA 413 MARCH ROAD P.O. BOX 13140 Kanata, Ontario, CA K2k 2b7 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-04 |
Decision Date | 1983-06-24 |