LHN · Class II · 21 CFR 892.5050

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

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

92
Total
92
Cleared
142d
Avg days
1985
Since
92 devices
49–72 of 92
Cleared Jan 21, 2004
INTUITION IMAGE
K032511
Brainlab AG
Radiology · 160d
Cleared Jul 20, 2001
NORTHEAST PROTON THERAPY CENTER
K983332
Massachusetts General Hospital
Radiology · 1032d
Cleared Jul 12, 2001
PROTON THERAPY SYSTEM
K983024
Ion Beam Applications S.A.
Radiology · 1046d
Cleared Aug 18, 2000
TREATVISION
K002194
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Jul 21, 2000
PROTON BEAM THERAPY SYSTEM (PBTS)
K992414
Optivus Technology, Inc.
Radiology · 367d
Cleared Jul 14, 1999
EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
K983660
Brainlab, Inc.
Radiology · 268d
Cleared Jun 08, 1999
RPM RESPIRATORY GATING SYSTEM
K983629
Varian Medical Systems, Inc.
Radiology · 236d
Cleared Mar 05, 1999
IMFAST
K982952
Siemens Medical Solutions USA, Inc.
Radiology · 193d
Cleared Dec 21, 1998
MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE
K983342
Philips Medical Systems (Cleveland), Inc.
Radiology · 89d
Cleared Nov 19, 1998
MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER
K982937
Victoreen, Inc.
Radiology · 90d
Cleared Jul 24, 1998
MOBETRON
K981112
Intraop Medical, Inc.
Radiology · 120d
Cleared Jul 13, 1998
ARTOSCAN S
K981358
Biosound Esaote, Inc.
Radiology · 90d
Cleared Jun 25, 1998
RADIO-PLAST
K981115
Smith & Nephew, Inc.
Radiology · 90d
Cleared Jan 14, 1998
MODEL 37-185
K973960
Victoreen, Inc.
Radiology · 90d
Cleared Sep 10, 1997
MULTIDOS, QC6PLUS
K972211
Ptw-New York Corp.
Radiology · 90d
Cleared Sep 10, 1997
0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER
K972212
Ptw-New York Corp.
Radiology · 90d
Cleared Mar 07, 1996
TREATMENT MANAGEMENT SYSTEM
K953391
Siemens Medical Solutions USA, Inc.
Radiology · 232d
Cleared Apr 26, 1989
INTRAOPERATIVE RADIATION THERAPY DEVICES
K891261
General Electric Co.
Radiology · 49d
Cleared Dec 05, 1985
COMPUTERIZED RADIATION TREATMENT PLANNING SYS
K853964
Computerized Medical Systems, Inc.
Radiology · 80d
Cleared Sep 20, 1985
TARGET CAT#B7850AA & B7850AB & B7850B
K851301
General Electric Co.
Radiology · 172d