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510(k) K211511

decimal Bolus by .Decimal, LLC — Product Code MUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2021
Date Received
May 14, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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  • 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)
  • K071078 — .DECIMAL RANGE COMPENSATOR (May 22, 2007)

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