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510(k) K060187

TOPSLANE DMLC by Topslane International, LLC — Product Code IXI

K060187 is an FDA 510(k) premarket notification submitted by Topslane International, LLC for the device "TOPSLANE DMLC". The FDA issued a decision of Substantially Equivalent on July 27, 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
July 27, 2006
Date Received
January 24, 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

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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)
  • K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (July 29, 2009)

FDA data resources