Home / 510(k) Clearances / K062781

510(k) K062781

MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY by Symtium Corporation — Product Code IXI

K062781 is an FDA 510(k) premarket notification submitted by Symtium Corporation for the device "MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY". The FDA issued a decision of Substantially Equivalent on November 21, 2006. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2006
Date Received
September 18, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Beam-Shaping, Radiation Therapy
Device Class
Class II
Regulation Number
892.5710
Review Panel
RA
Submission Type

Other clearances for product code IXI

  • K253025 — Ricoh 3D for Healthcare Bolus (April 6, 2026)
  • K222639 — VHA Radiotherapy Bolus (November 4, 2022)
  • K214093 — VSP Bolus (March 30, 2022)
  • K132236 — .DECIMAL PROTON APERTURE (October 16, 2013)
  • K131150 — CURA COMPENSATOR (July 30, 2013)
  • K123893 — CURA COLLIMATOR (March 4, 2013)
  • K123015 — .DECIMAL PHOTON BLOCK (November 21, 2012)
  • K111676 — APEX (September 30, 2011)
  • K111759 — .DECIMAL ELECTRON APERTURE (September 9, 2011)
  • K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (July 29, 2009)

FDA data resources