510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964607Substantially Equivalent

Theraton 1000E

Theratronics, Inc., Kanata, Ontario, Canada, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964607 is the FDA 510(k) clearance record for THERATON 1000E, a class II device, cleared for Theratronics, Inc. on under FDA product code IWD (Device, Beam Limiting, Teletherapy, Radionuclide). FDA records list 9 510(k) clearances for Theratronics, Inc., from to . As of , FDA records show one recall naming K964607.

Clearance record

Decision date
Received
(191 days to decision)
Product code
IWD Device, Beam Limiting, Teletherapy, Radionuclide
Regulation
21 CFR 892.5750
Device class
Class II
Review panel
Radiology
Applicant
Theratronics, Inc. 413 March Rd., Kanata, Ontario, Canada, CA
510(k) summary
Summary
Third party review
No

Clearances, product code IWD

Trailing 12 months

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

FDA records show no clearances under product code IWD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWD, 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