510(k) K837152

THERAC 25 LINEAR ACCELERATOR by Atomic Energy of Canada — Product Code JAI

K837152 is an FDA 510(k) premarket notification submitted by Atomic Energy of Canada for the device "THERAC 25 LINEAR ACCELERATOR". The FDA issued a decision of Substantially Equivalent on March 22, 1983. The device falls under product code JAI (Couch, Radiation Therapy, Powered), a Class II device regulated under 21 CFR 892.5770. Atomic Energy of Canada has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1983
Date Received
February 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Couch, Radiation Therapy, Powered
Device Class
Class II
Regulation Number
892.5770
Review Panel
RA
Submission Type