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
25–48 of 93
Cleared Apr 05, 2017
Anzai Respiratory Gating System
K170719
Anzai Medical Co., Ltd.
Radiology · 27d
Cleared Dec 08, 2016
ProNova SC360 Proton Therapy System
K162246
Pronova Solutions, LLC
Radiology · 120d
Cleared Aug 17, 2016
Sumitomo Proton Therapy System
K160612
Sumitomo Heavy Industries, Ltd.
Radiology · 167d
Cleared Aug 09, 2016
Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
K152224
Ion Beam Application S.A.
Radiology · 368d
Cleared Jul 13, 2016
PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
K161163
Hitachi , Ltd.
Radiology · 79d
Cleared Apr 22, 2016
Anzai Respiratory Gating System
K160432
Anzai Medical Co., Ltd.
Radiology · 66d
Cleared Apr 21, 2016
PROBEAT-V and accessories
K153614
Hitachi, Ltd., Health Care Company
Radiology · 126d
Cleared Feb 25, 2016
McLaren Proton Therapy System
K160063
Mclaren Health Care Corporation
Radiology · 43d
Cleared Nov 02, 2015
PROBEAT-V
K152592
Hitachi, Ltd., Health Care Company
Radiology · 53d
Cleared Oct 02, 2015
Extended Range Shifter for PROBEAT-V
K152207
Hitachi, Ltd., Health Care Company
Radiology · 57d
Cleared Jun 01, 2015
PROBEAT-V
K151132
Hitachi, Ltd., Health Care Company
Radiology · 34d
Cleared Jul 10, 2014
GANTRY BEAM LINE
K132919
Ion Beam Applications S.A.
Radiology · 296d
Cleared Apr 03, 2014
VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE
K133914
Medcom GmbH
Radiology · 101d
Cleared Mar 14, 2014
RADIANCE 330 PROTON THERAPY SYSTEM
K134052
Protom International, Inc.
Radiology · 73d
Cleared Jan 10, 2014
PROBEAM PROTON THERAPY SYSTEM
K133191
Varian Medical Systems
Radiology · 85d
Cleared Nov 20, 2013
I2C
K132847
Ion Beam Applications S.A.
Radiology · 70d
Cleared Nov 19, 2013
SUMITOMO PROTON THERAPY SYSTEM
K130426
Sumitomo Heavy Industries, Ltd.
Radiology · 272d
Cleared Feb 21, 2013
VERIFICATION CONSOLE
K124002
Varian Medical Systems
Radiology · 57d
Cleared Jun 04, 2012
S-250 PROTON BEAM RADIATION THERAPY SYSTEM
K120676
Mevion Medical Systems
Radiology · 91d
Cleared Mar 14, 2012
AIR-BAG SYSTEM
K112969
Niigata Mechatronics Co., Ltd.
Radiology · 161d
Cleared Jan 25, 2012
SUN 125C IONIZATION CHAMBER
K112981
Sun Nuclear Corp.
Radiology · 111d
Cleared Nov 18, 2011
CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
K112768
Calypso Medical Technologies, Inc.
Radiology · 57d
Cleared Dec 27, 2010
PT2 VARIAN PROTON THERAPY SYSTEM
K101294
Varian Medical Systems, Oncology Systems
Radiology · 231d
Cleared Sep 30, 2010
CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
K102373
Calypso Medical Technologies, Inc.
Radiology · 41d