Block, Beam-shaping, Radiation Therapy

Product Code: IXI

Radiology Radioisotope Therapy Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.5710


Radiation TypeIonizing
Radition SafetyNone
Annual ReportsNo

Products Classified as IXI

5308Block, Beam-shaping, Radiation TherapyRadiation Therapy Beam-shaping Block.

Total Product Life Cycle (TPLC) Devices

5308Block, Beam-shaping, Radiation TherapyRadiation Therapy Beam-shaping Block.

Pre-market Notifications for IXI

K222639VHA Radiotherapy BolusVHA DEAN
K214093VSP Bolus3D Systems
K132236.DECIMAL PROTON APERTURE.DECIMAL, INC.
K131150CURA COMPENSATORCURA MEDICAL TECHNOLOGIES, LLC
K123893CURA COLLIMATORCURA MEDICAL TECHNOLOGIES, LLC
K123015.DECIMAL PHOTON BLOCK.DECIMAL, INC.
K111759.DECIMAL ELECTRON APERTURE.DECIMAL, INC.
K111676APEXElekta Limited
K091911BOLUS COMPENSATOR.DECIMAL, INC.
K091403MOD1T COMPENSATORS FOR RADIATION BEAM THERAPYONCOLOGY TECH, LLC
K090417AXXENT FLEXISHIELD MINIXOFT, INC.
K071078.DECIMAL RANGE COMPENSATOR.DECIMAL, INC.
K071077.DECIMAL APERTURE.DECIMAL, INC.
K062781MOD1 COMPENSATORS FOR RADIATION BEAM THERAPYSYMTIUM CORPORATION
K060187TOPSLANE DMLCTOPSLANE INTERNATIONAL, LLC

Global Unique Device Identification Database

00851147007052Block, Beam-Shaping, Radiation Therapy
00851147007045Block, Beam-Shaping, Radiation Therapy
00851147007038Block, Beam-Shaping, Radiation Therapy
00851147007021Block, Beam-Shaping, Radiation Therapy
00851147007014Block, Beam-Shaping, Radiation Therapy
00851147007007Block, Beam-Shaping, Radiation Therapy
05060191071215Block, beam-shaping, radiation therapy
B365534260Block, Beam-Shaping, Radiation Therapy
B365534180Block, Beam-Shaping, Radiation Therapy
B365526260Block, Beam-Shaping, Radiation Therapy
B365524850Block, Beam-Shaping, Radiation Therapy
B365112900Block, Beam-Shaping, Radiation Therapy
B365112850Block, Beam-Shaping, Radiation Therapy
B365112700Block, Beam-Shaping, Radiation Therapy
B36511269020Block, Beam-Shaping, Radiation Therapy

Maude Adverse Events

.DECIMAL RANGE COMPENSATOR.DECIMAL2016-10-19
APEXELEKTA LTD2014-03-14
BEAM MODULATORELEKTA LIMITED2013-10-02
DMLC IVELEKTA LTD.2013-04-23
APEXELEKTA LTD.2012-11-28
APEXELEKTA LTD.2012-11-22
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEMXOFT, INC.2012-05-23
AXXENT FLEXISHIELD MINIXOFT, INC.2011-07-08
AXXENT FLEXISHIELD MINIXOFT, INC.2011-07-08
AXXENT FLEXISHIELD MINIXOFT, INC.2011-06-16
AXXENT FLEXISHIELD MINIXOFT, INC.2011-06-16
AXXENT FLEXSHIELD MINIXOFT, INC.2011-06-16
AXXENT FLEXISHIELD MINIXOFT, INC.2011-06-06
AXXENT FLEXISHIELD MINIXOFT, INC.2011-06-06
AXXENT FLEXISHIELD MINIXOFT, INC.2011-04-29
AXXENT FLEXISHIELD MINIXOFT, INC.2011-04-29
AXXENT FLEXISHIELD MINIXOFT, INC.2011-04-12
AXXENT FLEXISHIELD MINIXOFT, INC.2011-04-12
AXXENT FLEXISHIELD MINIXOFT, INC.2011-03-30
AXXENT FLEXISHIELD MINIXOFT, INC.2011-03-24
AXXENT FLEXISHIELD MINIXOFT, INC.2011-03-24
AXXENT FLEXISHIELD MINIXOFT, INC.2011-02-25
AXXENT FLEXISHIELD MINIXOFT, INC.2011-02-25
AXXENT FLEXSHIELD MINIXOFT, INC.2011-02-16
AXXENT FLEXISHIELD MINIXOFT, INC.2011-02-15
AXXENT FLEXISHIELD MINIXOFT, INC.2011-01-26
AXXENT FLEXISHIELD MINIXOFT, INC.2011-01-26
AXXENT FLEXISHIELD MINIXOFT, INC.2011-01-20
AXXENT FLEXISHIELD MINIXOFT, INC.2011-01-19
AXXENT FLEXISHIELD MINIXOFT, INC.2011-01-19
AXXENT FLEXISHIELD MINIXOFT, INC.2011-01-17
AXXENT FLEXISHIELD MINIXOFT, INC.2011-01-17
AXXENT FLEXISHIELD MINIXOFT, INC.2011-01-13
AXXENT FLEXISHIELD MINIXOFT, INC.2011-01-13
AXXENT FLEXISHIELD MINI (K090417)XOFT, INC.2011-01-07
SIEMENS BRAND NAME: MODULEAF MLCSIEMENS MEDICAL SOLUTIONS USA, INC.2010-12-10
PORTALCASTDIACOR, INC.2000-01-07
MULTILEAF COLLIMATOR W/DYNAMIC ARC THERAPYVARIAN ONCOLOGY SYSTEMS1999-05-20
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