Block, Beam-Shaping, Radiation Therapy
Regulation 892.5710
1510(k)s in 12 months (51 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in IXI
| Company | 510(k)s | Recalls |
|---|---|---|
| .Decimal, Inc. | 6 | 0 |
| Siemens Medical Solutions USA, Inc. | 5 | 1 |
| Elekta Limited | 1 | 3 |
| Aktina Medical Physics Corp. | 2 | 0 |
| Cura Medical Technologies, LLC | 2 | 0 |
| Huestis Machine Corp. | 2 | 0 |
| Med-Tec,Inc. | 2 | 0 |
| Medtec, Inc. | 2 | 0 |
| Mrc Systems GmbH | 2 | 0 |
| Xoft, Inc. | 1 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 6, 2026 | K253025 | Ricoh 3D for Healthcare Bolus Ricoh 3D For Healthcare, LLC | IXI |
| Nov 4, 2022 | K222639 | VHA Radiotherapy Bolus Vha Dean | IXI |
| Mar 30, 2022 | K214093 | VSP Bolus 3D Systems | IXI |
| Oct 16, 2013 | K132236 | .DECIMAL PROTON APERTURE .Decimal, Inc. | IXI |
| Jul 30, 2013 | K131150 | CURA COMPENSATOR Cura Medical Technologies, LLC | IXI |
| Mar 4, 2013 | K123893 | CURA COLLIMATOR Cura Medical Technologies, LLC | IXI |
| Nov 21, 2012 | K123015 | .DECIMAL PHOTON BLOCK .Decimal, Inc. | IXI |
| Sep 30, 2011 | K111676 | APEX Elekta Limited, GB | IXI |
| Sep 9, 2011 | K111759 | .DECIMAL ELECTRON APERTURE .Decimal, Inc. | IXI |
| Jul 29, 2009 | K091403 | MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY Oncology Tech, LLC | IXI |
| Jul 21, 2009 | K091911 | BOLUS COMPENSATOR .Decimal, Inc. | IXI |
| Jun 23, 2009 | K090417 | AXXENT FLEXISHIELD MINI Xoft, Inc. | IXI |
| May 22, 2007 | K071078 | .DECIMAL RANGE COMPENSATOR .Decimal, Inc. | IXI |
| May 18, 2007 | K071077 | .DECIMAL APERTURE .Decimal, Inc. | IXI |
| Nov 21, 2006 | K062781 | MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY Symtium Corporation | IXI |
| Jul 27, 2006 | K060187 | TOPSLANE DMLC Topslane International, LLC | IXI |
| Mar 29, 2006 | K052383 | INNOCURE IMRT FILTER (COMPENSATORS) Innocure, LLC | IXI |
| Apr 28, 2004 | K040804 | .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR Southeastern Radiation Products, Inc. | IXI |
| Apr 1, 2004 | K040553 | MODIFICATION TO ACCULEAF Direx Systems Corp. | IXI |
| Oct 2, 2003 | K032790 | MICROMLC Siemens Medical Solutions USA, Inc. | IXI |
| Mar 17, 2003 | K030609 | MODULEAF Mrc Systems GmbH, DE | IXI |
| Dec 27, 2002 | K021987 | PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY S&S Par Scientific | IXI |
| Sep 27, 2002 | K013875 | MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE Med-Tec,Inc. | IXI |
| Sep 7, 2001 | K011816 | MINI MULTILEAF COLLIMATOR, MODEL KMI Mrc Systems GmbH, DE | IXI |
| Apr 18, 2001 | K010172 | LEAD BLOCKS Arplay Medical S.A., FR | IXI |
| Oct 23, 2000 | K001163 | DMLC IV-ERGO 3D Line USA, Inc. | IXI |
| May 3, 2000 | K000349 | MOTORIZED MICRO MULTILEAF COLLIMATOR Stryker Leibinger | IXI |
| Apr 17, 2000 | K000137 | ENHANCED COMPENSATING FILTER Computerized Medical Systems, Inc. | IXI |
| Apr 5, 1999 | K990491 | ANGIO-CT MIYABI Siemens Medical Solutions USA, Inc. | IXI |
| Dec 15, 1998 | K981992 | ELECTRON WEDGE MODEL MT-EW-1000 Med-Tec,Inc. | IXI |
| Feb 10, 1998 | K974239 | AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM Aktina Medical Physics Corp. | IXI |
| Jan 14, 1998 | K973953 | AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM Aktina Medical Physics Corp. | IXI |
| Dec 4, 1997 | K972016 | AUTIMO 2.5-D AND AUTIMO 3-D C.L. Mcintosh & Assoc., Inc. | IXI |
| Jun 13, 1997 | K971001 | AUTIMO Medizintechnik, GmbH | IXI |
| Apr 25, 1997 | K970303 | SATURNE MULTILEAF COLLIMATOR General Electric Co. | IXI |
| Aug 8, 1996 | K961902 | SIEMENS BEAM SHAPER Siemens Medical Solutions USA, Inc. | IXI |
| Jan 5, 1996 | K954248 | SIEMENS VIRTURAL WEDGE Siemens Medical Solutions USA, Inc. | IXI |
| Nov 22, 1995 | K953227 | CASPER Northwest Medical Physics Center | IXI |
| Nov 13, 1995 | K953894 | SIEMENS MULTILEAF COLLIMATOR Siemens Medical Solutions USA, Inc. | IXI |
| Feb 15, 1995 | K940412 | MULTILEAF INTENSITY MODULATING COLLIMATOR Nomos Corp. | IXI |
| Dec 23, 1994 | K943343 | FIELD ABUTMENT WEDGE Medtec, Inc. | IXI |
| Jul 18, 1994 | K941719 | 360 DEG. ROTATING 1/2 BEAM BLOCK Medtec, Inc. | IXI |
| Jan 30, 1991 | K904124 | PHILIPS MULTILEAF COLLIMATOR (MLC) Philips Medical Systems, Inc., NL | IXI |
| May 31, 1990 | K901567 | THE HUESTIS COMPU-PLOTTER Huestis Machine Corp. | IXI |
| Aug 10, 1989 | K893464 | VARIAN MULTILEAF COLLIMATOR Varian Assoc., Inc. | IXI |
| Apr 26, 1989 | K883317 | DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST S & S X-Ray Products, Inc. | IXI |
| Apr 11, 1988 | K880047 | HUESTIS COMPU-FORMER Huestis Machine Corp. | IXI |
| Jan 30, 1986 | K860193 | PORTALCAST Diacor, Inc. | IXI |
| Aug 7, 1985 | K852353 | DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM Thomson-Cgr Medical Corp. | IXI |
| Sep 4, 1984 | K842615 | CLARK PRECISION BLOCK CUTTER, COOLING Clark Research and Development, Inc. | IXI |
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