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510(k) K964606

THERATRON 780E by Theratronics, Inc. — Product Code IWB

K964606 is an FDA 510(k) premarket notification submitted by Theratronics, Inc. for the device "THERATRON 780E". The FDA issued a decision of Substantially Equivalent on June 26, 1997. The device falls under product code IWB (System, Radiation Therapy, 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
June 26, 1997
Date Received
November 18, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, 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)
  • K964607 — THERATON 1000E (May 28, 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)

Other clearances for product code IWB

  • K250391 — Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamm (July 2, 2025)
  • K232854 — Leksell GammaPlan (LGP) (February 8, 2024)
  • K222047 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - E (October 26, 2022)
  • K203250 — TaiChiC (March 12, 2021)
  • K203146 — Akesis Galaxy RTi (March 5, 2021)
  • K200050 — Akesis Galaxy RTx (February 4, 2020)
  • K190844 — Akesis Galaxy (September 4, 2019)
  • K180571 — GammaPod (April 4, 2018)
  • K173789 — Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (March 30, 2018)
  • K173791 — Leksell GammaPlan (February 9, 2018)

FDA data resources