Atlas FDA

IXI

51 FDA 510(k) clearances · Product code

90 daysmedian time to decision
196 days90th percentile
51clearances measured

FDA profile

Official device name
Block, Beam-Shaping, Radiation Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5710
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1999: 1 · 2000: 1 · 2011: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Ricoh 3D for Healthcare Bolus (K253025)Ricoh 3D For Healthcare, LLC2026-04-06
VHA Radiotherapy Bolus (K222639)Vha Dean2022-11-04
VSP Bolus (K214093)3D Systems2022-03-30
.DECIMAL PROTON APERTURE (K132236).Decimal, Inc.2013-10-16
CURA COMPENSATOR (K131150)Cura Medical Technologies, LLC2013-07-30
CURA COLLIMATOR (K123893)Cura Medical Technologies, LLC2013-03-04
.DECIMAL PHOTON BLOCK (K123015).Decimal, Inc.2012-11-21
APEX (K111676)Elekta Limited2011-09-30
.DECIMAL ELECTRON APERTURE (K111759).Decimal, Inc.2011-09-09
MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY (K091403)Oncology Tech, LLC2009-07-29
BOLUS COMPENSATOR (K091911).Decimal, Inc.2009-07-21
AXXENT FLEXISHIELD MINI (K090417)Xoft, Inc.2009-06-23
.DECIMAL RANGE COMPENSATOR (K071078).Decimal, Inc.2007-05-22
.DECIMAL APERTURE (K071077).Decimal, Inc.2007-05-18
MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY (K062781)Symtium Corporation2006-11-21
TOPSLANE DMLC (K060187)Topslane International, LLC2006-07-27
INNOCURE IMRT FILTER (COMPENSATORS) (K052383)Innocure, LLC2006-03-29
.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR (K040804)Southeastern Radiation Products, Inc.2004-04-28
MODIFICATION TO ACCULEAF (K040553)Direx Systems Corp.2004-04-01
MICROMLC (K032790)Siemens Medical Solutions USA, Inc.2003-10-02
MODULEAF (K030609)Mrc Systems GmbH2003-03-17
PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY (K021987)S&S Par Scientific2002-12-27
MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE (K013875)Med-Tec,Inc.2002-09-27
MINI MULTILEAF COLLIMATOR, MODEL KMI (K011816)Mrc Systems GmbH2001-09-07
LEAD BLOCKS (K010172)Arplay Medical S.A.2001-04-18
DMLC IV-ERGO (K001163)3D Line USA, Inc.2000-10-23
MOTORIZED MICRO MULTILEAF COLLIMATOR (K000349)Stryker Leibinger2000-05-03
ENHANCED COMPENSATING FILTER (K000137)Computerized Medical Systems, Inc.2000-04-17
ANGIO-CT MIYABI (K990491)Siemens Medical Solutions USA, Inc.1999-04-05
ELECTRON WEDGE MODEL MT-EW-1000 (K981992)Med-Tec,Inc.1998-12-15
AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM (K974239)Aktina Medical Physics Corp.1998-02-10
AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM (K973953)Aktina Medical Physics Corp.1998-01-14
AUTIMO 2.5-D AND AUTIMO 3-D (K972016)C.L. Mcintosh & Assoc., Inc.1997-12-04
AUTIMO (K971001)Medizintechnik, GmbH1997-06-13
SATURNE MULTILEAF COLLIMATOR (K970303)General Electric Co.1997-04-25
SIEMENS BEAM SHAPER (K961902)Siemens Medical Solutions USA, Inc.1996-08-08
SIEMENS VIRTURAL WEDGE (K954248)Siemens Medical Solutions USA, Inc.1996-01-05
CASPER (K953227)Northwest Medical Physics Center1995-11-22
SIEMENS MULTILEAF COLLIMATOR (K953894)Siemens Medical Solutions USA, Inc.1995-11-13
MULTILEAF INTENSITY MODULATING COLLIMATOR (K940412)Nomos Corp.1995-02-15
FIELD ABUTMENT WEDGE (K943343)Medtec, Inc.1994-12-23
360 DEG. ROTATING 1/2 BEAM BLOCK (K941719)Medtec, Inc.1994-07-18
PHILIPS MULTILEAF COLLIMATOR (MLC) (K904124)Philips Medical Systems, Inc.1991-01-30
THE HUESTIS COMPU-PLOTTER (K901567)Huestis Machine Corp.1990-05-31
VARIAN MULTILEAF COLLIMATOR (K893464)Varian Assoc., Inc.1989-08-10
DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST (K883317)S & S X-Ray Products, Inc.1989-04-26
HUESTIS COMPU-FORMER (K880047)Huestis Machine Corp.1988-04-11
PORTALCAST (K860193)Diacor, Inc.1986-01-30
DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM (K852353)Thomson-Cgr Medical Corp.1985-08-07
CLARK PRECISION BLOCK CUTTER, COOLING (K842615)Clark Research and Development, Inc.1984-09-04
MYVACET 5-07, 7-00 AND 9-40 (K791178)Radiation Products Design, Inc.1979-09-17

Track IXI automatically

Every clearance here is in the API, with alerts when new ones post.