IXI · Class II · 21 CFR 892.5710

FDA Product Code IXI: Block, Beam-shaping, Radiation Therapy

Leading manufacturers include Siemens Medical Solutions USA, Inc., .Decimal, Inc. and Cura Medical Technologies, LLC.

51
Total
51
Cleared
108d
Avg days
1979
Since
51 devices
25–48 of 51
Cleared Feb 15, 1995
MULTILEAF INTENSITY MODULATING COLLIMATOR
K940412
Nomos Corp.
Radiology · 384d
Cleared Dec 23, 1994
FIELD ABUTMENT WEDGE
K943343
Medtec, Inc.
Radiology · 164d
Cleared Jul 18, 1994
360 DEG. ROTATING 1/2 BEAM BLOCK
K941719
Medtec, Inc.
Radiology · 102d
Cleared Jan 30, 1991
PHILIPS MULTILEAF COLLIMATOR (MLC)
K904124
Philips Medical Systems, Inc.
Radiology · 146d
Cleared Aug 10, 1989
VARIAN MULTILEAF COLLIMATOR
K893464
Varian Assoc., Inc.
Radiology · 99d