Block, Beam-Shaping, Radiation Therapy

FDA product code IXI · 51 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.5710
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1979-09-17 – 2026-04-06

IXI 2026-04-06

Ricoh 3D for Healthcare Bolus

Applicant Ricoh 3D For Healthcare, LLC

K number K253025

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IXI 2022-11-04

VHA Radiotherapy Bolus

Applicant Vha Dean

K number K222639

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IXI 2022-03-30

VSP Bolus

Applicant 3D Systems

K number K214093

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IXI 2013-10-16

.DECIMAL PROTON APERTURE

Applicant .Decimal, Inc.

K number K132236

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IXI 2013-07-30

CURA COMPENSATOR

Applicant Cura Medical Technologies, LLC

K number K131150

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IXI 2013-03-04

CURA COLLIMATOR

Applicant Cura Medical Technologies, LLC

K number K123893

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IXI 2012-11-21

.DECIMAL PHOTON BLOCK

Applicant .Decimal, Inc.

K number K123015

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IXI 2011-09-30

APEX

Applicant Elekta Limited

K number K111676

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IXI 2011-09-09

.DECIMAL ELECTRON APERTURE

Applicant .Decimal, Inc.

K number K111759

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IXI 2009-07-29

MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY

Applicant Oncology Tech, LLC

K number K091403

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IXI 2009-07-21

BOLUS COMPENSATOR

Applicant .Decimal, Inc.

K number K091911

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IXI 2009-06-23

AXXENT FLEXISHIELD MINI

Applicant Xoft, Inc.

K number K090417

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IXI 2007-05-22

.DECIMAL RANGE COMPENSATOR

Applicant .Decimal, Inc.

K number K071078

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IXI 2007-05-18

.DECIMAL APERTURE

Applicant .Decimal, Inc.

K number K071077

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IXI 2006-11-21

MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY

Applicant Symtium Corporation

K number K062781

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IXI 2006-07-27

TOPSLANE DMLC

Applicant Topslane International, LLC

K number K060187

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IXI 2006-03-29

INNOCURE IMRT FILTER (COMPENSATORS)

Applicant Innocure, LLC

K number K052383

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IXI 2004-04-28

.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR

Applicant Southeastern Radiation Products, Inc.

K number K040804

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IXI 2004-04-01

MODIFICATION TO ACCULEAF

Applicant Direx Systems Corp.

K number K040553

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IXI 2003-10-02

MICROMLC

Applicant Siemens Medical Solutions USA, Inc.

K number K032790

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IXI 2003-03-17

MODULEAF

Applicant Mrc Systems GmbH

K number K030609

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IXI 2002-12-27

PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY

Applicant S&S Par Scientific

K number K021987

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IXI 2002-09-27

MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE

Applicant Med-Tec,Inc.

K number K013875

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IXI 2001-09-07

MINI MULTILEAF COLLIMATOR, MODEL KMI

Applicant Mrc Systems GmbH

K number K011816

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IXI 2001-04-18

LEAD BLOCKS

Applicant Arplay Medical S.A.

K number K010172

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IXI 2000-10-23

DMLC IV-ERGO

Applicant 3D Line USA, Inc.

K number K001163

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IXI 2000-05-03

MOTORIZED MICRO MULTILEAF COLLIMATOR

Applicant Stryker Leibinger

K number K000349

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IXI 2000-04-17

ENHANCED COMPENSATING FILTER

Applicant Computerized Medical Systems, Inc.

K number K000137

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IXI 1999-04-05

ANGIO-CT MIYABI

Applicant Siemens Medical Solutions USA, Inc.

K number K990491

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IXI 1998-12-15

ELECTRON WEDGE MODEL MT-EW-1000

Applicant Med-Tec,Inc.

K number K981992

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IXI 1998-02-10

AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM

Applicant Aktina Medical Physics Corp.

K number K974239

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IXI 1998-01-14

AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM

Applicant Aktina Medical Physics Corp.

K number K973953

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IXI 1997-12-04

AUTIMO 2.5-D AND AUTIMO 3-D

Applicant C.L. Mcintosh & Assoc., Inc.

K number K972016

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IXI 1997-06-13

AUTIMO

Applicant Medizintechnik, GmbH

K number K971001

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IXI 1997-04-25

SATURNE MULTILEAF COLLIMATOR

Applicant General Electric Co.

K number K970303

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IXI 1996-08-08

SIEMENS BEAM SHAPER

Applicant Siemens Medical Solutions USA, Inc.

K number K961902

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IXI 1996-01-05

SIEMENS VIRTURAL WEDGE

Applicant Siemens Medical Solutions USA, Inc.

K number K954248

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IXI 1995-11-22

CASPER

Applicant Northwest Medical Physics Center

K number K953227

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IXI 1995-11-13

SIEMENS MULTILEAF COLLIMATOR

Applicant Siemens Medical Solutions USA, Inc.

K number K953894

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IXI 1995-02-15

MULTILEAF INTENSITY MODULATING COLLIMATOR

Applicant Nomos Corp.

K number K940412

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IXI 1994-12-23

FIELD ABUTMENT WEDGE

Applicant Medtec, Inc.

K number K943343

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IXI 1994-07-18

360 DEG. ROTATING 1/2 BEAM BLOCK

Applicant Medtec, Inc.

K number K941719

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IXI 1991-01-30

PHILIPS MULTILEAF COLLIMATOR (MLC)

Applicant Philips Medical Systems, Inc.

K number K904124

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IXI 1990-05-31

THE HUESTIS COMPU-PLOTTER

Applicant Huestis Machine Corp.

K number K901567

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IXI 1989-08-10

VARIAN MULTILEAF COLLIMATOR

Applicant Varian Assoc., Inc.

K number K893464

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IXI 1989-04-26

DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST

Applicant S & S X-Ray Products, Inc.

K number K883317

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IXI 1988-04-11

HUESTIS COMPU-FORMER

Applicant Huestis Machine Corp.

K number K880047

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IXI 1986-01-30

PORTALCAST

Applicant Diacor, Inc.

K number K860193

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IXI 1985-08-07

DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM

Applicant Thomson-Cgr Medical Corp.

K number K852353

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IXI 1984-09-04

CLARK PRECISION BLOCK CUTTER, COOLING

Applicant Clark Research and Development, Inc.

K number K842615

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IXI 1979-09-17

MYVACET 5-07, 7-00 AND 9-40

Applicant Radiation Products Design, Inc.

K number K791178

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