FDA.reportPublic FDA data

510(k) K990491

Device
Angio-ct Miyabi
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
510(k) number
K990491
Product code
IXI
Decision
Substantially Equivalent (SESE)
Decision date
1999-04-05
Date received
1999-02-17
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
ALICIA BUSTOS-JUERGENSEN
Address
186 Wood Ave. S. Iselin NJ US 08830 08830

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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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
K071077.DECIMAL APERTURE.Decimal, Inc.2007-05-18
K062781MOD1 COMPENSATORS FOR RADIATION BEAM THERAPYSymtium Corporation2006-11-21