LHN · Class II · 21 CFR 892.5050

FDA Product Code LHN: System, Radiation Therapy, Charged-particle, Medical

Leading manufacturers include Ion Beam Applications S.A., Varian Medical Systems, Inc. and Hitachi, Ltd., Health Care Company.

93
Total
93
Cleared
143d
Avg days
1985
Since
93 devices
49–72 of 93
Cleared Aug 06, 2010
MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
K101508
Ion Beam Applications S.A.
Radiology · 66d
Cleared Jul 21, 2010
IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
K100766
Ion Beam Applications S.A.
Radiology · 126d
Cleared Dec 24, 2009
PROTON THERAPY MULTILEAF COLLIMATOR
K093250
Varian Medical Systems
Radiology · 69d
Cleared Dec 22, 2009
IBA PROTON THERAPY SYSTEM, PROTEUS 235
K092796
Ion Beam Applications S.A.
Radiology · 102d
Cleared Sep 18, 2009
VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
K092653
Medcom GmbH
Radiology · 21d
Cleared Aug 11, 2009
PROTEUS 235 PROTON THERAPY SYSTEM
K091629
Ion Beam Applications S.A.
Radiology · 69d
Cleared Apr 15, 2009
IBA PROTON THERAPY SYSTEM - PROTEUS 235
K083058
Ion Beam Applications S.A.
Radiology · 183d
Cleared Dec 12, 2008
IBA PROTON THERAPY SYSTEM- PROTEUS 235
K082416
Ion Beam Applications S.A.
Radiology · 113d
Cleared Aug 07, 2008
ATLAS-BASED AUTOSEGMENTATION
K080799
Computerized Medical Systems, Inc.
Radiology · 139d
Cleared Jun 24, 2008
IPLAN RT IMAGE
K080886
Brainlab AG
Radiology · 85d
Cleared Dec 10, 2007
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
K073059
Hitachi, Ltd., Power Systems Group
Radiology · 41d
Cleared Jun 20, 2007
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
K071399
Sicel Technologies, Inc.
Radiology · 30d
Cleared Dec 14, 2006
PROTON THERAPY SYSTEM
K062891
Indiana University Cyclotron Facility
Radiology · 79d
Cleared Jul 28, 2006
IBA PROTON THERAPY SYSTEM - PROTEUS 235
K061913
Ion Beam Applications S.A.
Radiology · 22d
Cleared Jun 13, 2006
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
K061051
Sicel Technologies, Inc.
Radiology · 57d
Cleared May 10, 2006
MUCHECK V7.0
K061152
Oncology Data Systems, Inc.
Radiology · 14d
Cleared Apr 19, 2006
PROBEAT WITH MGCS
K060834
Hitachi , Ltd.
Radiology · 23d
Cleared Apr 11, 2006
IBA PROTON THERAPY SYSTEM - PROTEUS 235
K060695
Ion Beam Applications S.A.
Radiology · 26d
Cleared Apr 03, 2006
DOSE VERIFICATION SYSTEM
K052118
Sicel Technologies, Inc.
Radiology · 242d
Cleared Mar 09, 2006
PROBEAT
K053280
Hitachi, Ltd., Power Systems Group
Radiology · 106d
Cleared Jan 24, 2006
IBA PROTON THERAPY SYSTEM-PROTEUS 235
K053641
Ion Beam Applications S.A.
Radiology · 25d
Cleared Jan 21, 2004
INTUITION IMAGE
K032511
Brainlab AG
Radiology · 160d
Cleared Jan 09, 2004
DIAMOND SETUP 2000
K032886
K&S Assoc., Inc.
Radiology · 115d
Cleared Nov 10, 2003
ANZAI AZ-733 RESPIRATORY GATING SYSTEM
K031385
Anzai Medical Co., Ltd.
Radiology · 193d