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510(k) K123015

.DECIMAL PHOTON BLOCK by .Decimal, Inc. — Product Code IXI

K123015 is an FDA 510(k) premarket notification submitted by .Decimal, Inc. for the device ".DECIMAL PHOTON BLOCK". The FDA issued a decision of Substantially Equivalent on November 21, 2012. 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
November 21, 2012
Date Received
September 28, 2012
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)
  • K111759 — .DECIMAL ELECTRON APERTURE (September 9, 2011)
  • K091911 — BOLUS COMPENSATOR (July 21, 2009)
  • 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)
  • K111676 — APEX (September 30, 2011)
  • K111759 — .DECIMAL ELECTRON APERTURE (September 9, 2011)
  • K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (July 29, 2009)
  • K091911 — BOLUS COMPENSATOR (July 21, 2009)

FDA data resources