510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850543Substantially Equivalent

Theratron 780C a Radionuclide Radiation Therapy Sy

Atomic Energy of Canada, Kanata, Ontario, Canada, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850543 is the FDA 510(k) clearance record for THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY, a class II device, cleared for Atomic Energy of Canada on under FDA product code IWB (System, Radiation Therapy, Radionuclide). FDA records list 6 510(k) clearances for Atomic Energy of Canada, from to . As of , FDA records show no recalls naming K850543.

Clearance record

Decision date
Received
(88 days to decision)
Product code
IWB System, Radiation Therapy, Radionuclide
Regulation
21 CFR 892.5750
Device class
Class II
Review panel
Radiology
Applicant
Atomic Energy of Canada 413 March Rd., Kanata, Ontario, Canada, CA
Third party review
No

Clearances, product code IWB

Trailing 12 months

FDA records hold no clearances under product code IWB in the trailing twelve months.

FDA records show no clearances under product code IWB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260