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510(k) K091403

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

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

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  • 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)
  • K090417 — AXXENT FLEXISHIELD MINI (June 23, 2009)