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510(k) K964607

THERATON 1000E by Theratronics, Inc. — Product Code IWD

K964607 is an FDA 510(k) premarket notification submitted by Theratronics, Inc. for the device "THERATON 1000E". The FDA issued a decision of Substantially Equivalent on May 28, 1997. The device falls under product code IWD (Device, Beam Limiting, Teletherapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Theratronics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1997
Date Received
November 18, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Beam Limiting, Teletherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5750
Review Panel
RA
Submission Type

Other clearances by Theratronics, Inc.

  • K983917 — THERATRON ELITE (December 4, 1998)
  • K970236 — THERAPLAN PLUS VERSION 1.2 (July 9, 1997)
  • K964606 — THERATRON 780E (June 26, 1997)
  • K954679 — THERAPLAN PLUS (November 8, 1996)
  • K940237 — THERAPLAN V05B/ TP-11 V09B (July 26, 1994)
  • K922276 — THERAC 25 (May 25, 1994)
  • K894165 — THERATRON 1000 (February 1, 1990)
  • K820782 — THERATRONIC STIMULATOR (June 3, 1982)

FDA data resources