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510(k) K983917

THERATRON ELITE by Theratronics, Inc. — Product Code IWB

K983917 is an FDA 510(k) premarket notification submitted by Theratronics, Inc. for the device "THERATRON ELITE". The FDA issued a decision of Substantially Equivalent on December 4, 1998. 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
December 4, 1998
Date Received
November 4, 1998
Clearance Type
Special
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.

  • K970236 — THERAPLAN PLUS VERSION 1.2 (July 9, 1997)
  • K964606 — THERATRON 780E (June 26, 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