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510(k) K001006

THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE by Mds Nordion — Product Code IWB

K001006 is an FDA 510(k) premarket notification submitted by Mds Nordion for the device "THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE". The FDA issued a decision of Substantially Equivalent on April 27, 2000. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Mds Nordion has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2000
Date Received
March 29, 2000
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 Mds Nordion

  • K060870 — AVANZA (May 15, 2006)
  • K053485 — THERATRON EQUINOX, MODELS 80 CM AND 100 CM (March 9, 2006)
  • K051065 — RAYCELL X-RAY BLOOD IRRADIATOR (May 26, 2005)
  • K050963 — GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN (May 20, 2005)
  • K032684 — RAYCELL (September 26, 2003)
  • K020971 — DCM 2.0 (June 6, 2002)
  • K010682 — HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM (June 5, 2001)
  • K011246 — DCM 1.0 (May 23, 2001)

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