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510(k) K071077

Device
.DECIMAL APERTURE
Applicant
.DECIMAL, INC.
510(k) number
K071077
Product code
IXI  
Decision
Substantially Equivalent (SESE)
Decision date
2007-05-18
Date received
2007-04-17
Regulation
892.5710
Classification name
Block, Beam-shaping, Radiation Therapy
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DANIEL BENNETT
Address
121 Central Park Pl. Sanford FL US 32771 32771

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IXI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253025Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLC2026-04-06
K222639VHA Radiotherapy BolusVha Dean2022-11-04
K214093VSP Bolus3D Systems2022-03-30
K132236.DECIMAL PROTON APERTURE.Decimal, Inc.2013-10-16
K131150CURA COMPENSATORCura Medical Technologies, LLC2013-07-30
K123893CURA COLLIMATORCura Medical Technologies, LLC2013-03-04
K123015.DECIMAL PHOTON BLOCK.Decimal, Inc.2012-11-21
K111676APEXElekta Limited2011-09-30
K111759.DECIMAL ELECTRON APERTURE.Decimal, Inc.2011-09-09
K091403MOD1T COMPENSATORS FOR RADIATION BEAM THERAPYOncology Tech, LLC2009-07-29
K091911BOLUS COMPENSATOR.Decimal, Inc.2009-07-21
K090417AXXENT FLEXISHIELD MINIXoft, Inc.2009-06-23
K071078.DECIMAL RANGE COMPENSATOR.Decimal, Inc.2007-05-22
K062781MOD1 COMPENSATORS FOR RADIATION BEAM THERAPYSymtium Corporation2006-11-21
K060187TOPSLANE DMLCTopslane International, LLC2006-07-27

Legacy Summary#

summary

FDA Review#

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