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510(k) K071077

.DECIMAL APERTURE by .Decimal, Inc. — Product Code IXI

K071077 is an FDA 510(k) premarket notification submitted by .Decimal, Inc. for the device ".DECIMAL APERTURE". The FDA issued a decision of Substantially Equivalent on May 18, 2007. 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
May 18, 2007
Date Received
April 17, 2007
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 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)
  • K091911 — BOLUS COMPENSATOR (July 21, 2009)
  • K083672 — P.D SOFTWARE (April 13, 2009)

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