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510(k) K091403

MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY by Oncology Tech, LLC — Product Code IXI

K091403 is an FDA 510(k) premarket notification submitted by Oncology Tech, LLC for the device "MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY". The FDA issued a decision of Substantially Equivalent on July 29, 2009. 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
July 29, 2009
Date Received
May 12, 2009
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

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  • 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)
  • K091911 — BOLUS COMPENSATOR (July 21, 2009)

FDA data resources