510(k) K771260

LINEAR ACCELERATOR G-2900 by Atomic Energy of Canada — Product Code IYE

K771260 is an FDA 510(k) premarket notification submitted by Atomic Energy of Canada for the device "LINEAR ACCELERATOR G-2900". The FDA issued a decision of Substantially Equivalent on August 3, 1977. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Atomic Energy of Canada has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1977
Date Received
July 13, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type