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510(k) K091911

BOLUS COMPENSATOR by .Decimal, Inc. — Product Code IXI

K091911 is an FDA 510(k) premarket notification submitted by .Decimal, Inc. for the device "BOLUS COMPENSATOR". The FDA issued a decision of Substantially Equivalent on July 21, 2009. The device falls under product code IXI (Block, Beam-Shaping, Radiation Therapy), a Class II device regulated under 21 CFR 892.5710. .Decimal, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2009
Date Received
June 25, 2009
Clearance Type
Special
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 by .Decimal, Inc.

  • K211511 — decimal Bolus (July 1, 2021)
  • K192554 — decimal3D (December 13, 2019)
  • K173940 — Astroid Planning App (May 15, 2018)
  • K151369 — .decimal p.d (August 7, 2015)
  • K150547 — .decimal Astroid Dosimetry App (May 15, 2015)
  • K132236 — .DECIMAL PROTON APERTURE (October 16, 2013)
  • K123015 — .DECIMAL PHOTON BLOCK (November 21, 2012)
  • K111759 — .DECIMAL ELECTRON APERTURE (September 9, 2011)
  • K083672 — P.D SOFTWARE (April 13, 2009)
  • K071078 — .DECIMAL RANGE COMPENSATOR (May 22, 2007)

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