IXI · Class II · 21 CFR 892.5710

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

Leading manufacturers include .Decimal, Inc., Siemens Medical Solutions USA, Inc. and Medtec, Inc..

51
Total
51
Cleared
108d
Avg days
1979
Since
51 devices
25–48 of 51
Cleared Apr 18, 2001
LEAD BLOCKS
K010172
Arplay Medical S.A.
Radiology · 90d
Cleared Oct 23, 2000
DMLC IV-ERGO
K001163
3D Line USA, Inc.
Radiology · 196d
Cleared May 03, 2000
MOTORIZED MICRO MULTILEAF COLLIMATOR
K000349
Stryker Leibinger
Radiology · 90d
Cleared Apr 17, 2000
ENHANCED COMPENSATING FILTER
K000137
Computerized Medical Systems, Inc.
Radiology · 90d
Cleared Apr 05, 1999
ANGIO-CT MIYABI
K990491
Siemens Medical Solutions USA, Inc.
Radiology · 47d
Cleared Dec 15, 1998
ELECTRON WEDGE MODEL MT-EW-1000
K981992
Med-Tec,Inc.
Radiology · 190d
Cleared Feb 10, 1998
AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM
K974239
Aktina Medical Physics Corp.
Radiology · 90d
Cleared Jan 14, 1998
AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM
K973953
Aktina Medical Physics Corp.
Radiology · 90d
Cleared Dec 04, 1997
AUTIMO 2.5-D AND AUTIMO 3-D
K972016
C.L. Mcintosh & Assoc., Inc.
Radiology · 188d
Cleared Jun 13, 1997
AUTIMO
K971001
Medizintechnik, GmbH
Radiology · 86d
Cleared Apr 25, 1997
SATURNE MULTILEAF COLLIMATOR
K970303
General Electric Co.
Radiology · 88d
Cleared Aug 08, 1996
SIEMENS BEAM SHAPER
K961902
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jan 05, 1996
SIEMENS VIRTURAL WEDGE
K954248
Siemens Medical Solutions USA, Inc.
Radiology · 116d
Cleared Nov 22, 1995
CASPER
K953227
Northwest Medical Physics Center
Radiology · 140d
Cleared Nov 13, 1995
SIEMENS MULTILEAF COLLIMATOR
K953894
Siemens Medical Solutions USA, Inc.
Radiology · 88d
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 May 31, 1990
THE HUESTIS COMPU-PLOTTER
K901567
Huestis Machine Corp.
Radiology · 58d
Cleared Aug 10, 1989
VARIAN MULTILEAF COLLIMATOR
K893464
Varian Assoc., Inc.
Radiology · 99d
Cleared Apr 26, 1989
DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST
K883317
S & S X-Ray Products, Inc.
Radiology · 264d
Cleared Apr 11, 1988
HUESTIS COMPU-FORMER
K880047
Huestis Machine Corp.
Radiology · 96d
Cleared Jan 30, 1986
PORTALCAST
K860193
Diacor, Inc.
Radiology · 8d