LHN · Class II · 21 CFR 892.5050

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

Leading manufacturers include Varian Medical Systems, Inc., Victoreen, Inc. and Brainlab AG.

92
Total
92
Cleared
142d
Avg days
1985
Since
92 devices
25–48 of 92
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 Jun 25, 1998
RADIO-PLAST
K981115
Smith & Nephew, Inc.
Radiology · 90d
Cleared Jan 14, 1998
MODEL 37-185
K973960
Victoreen, Inc.
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 Sep 20, 1985
TARGET CAT#B7850AA & B7850AB & B7850B
K851301
General Electric Co.
Radiology · 172d