FDA Product Code
FDA Product Code IXI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5710
510(k) Clearances — 51 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253025 | Ricoh 3D for Healthcare Bolus | Ricoh 3D For Healthcare, LLC | 2026-04-06 | Traditional | PDF ↗ |
| K222639 | VHA Radiotherapy Bolus | Vha Dean | 2022-11-04 | Traditional | PDF ↗ |
| K214093 | VSP Bolus | 3D Systems | 2022-03-30 | Traditional | PDF ↗ |
| K132236 | .DECIMAL PROTON APERTURE | .Decimal, Inc. | 2013-10-16 | Traditional | PDF ↗ |
| K131150 | CURA COMPENSATOR | Cura Medical Technologies, LLC | 2013-07-30 | Traditional | PDF ↗ |
| K123893 | CURA COLLIMATOR | Cura Medical Technologies, LLC | 2013-03-04 | Traditional | PDF ↗ |
| K123015 | .DECIMAL PHOTON BLOCK | .Decimal, Inc. | 2012-11-21 | Traditional | PDF ↗ |
| K111676 | APEX | Elekta Limited | 2011-09-30 | Traditional | PDF ↗ |
| K111759 | .DECIMAL ELECTRON APERTURE | .Decimal, Inc. | 2011-09-09 | Traditional | PDF ↗ |
| K091403 | MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY | Oncology Tech, LLC | 2009-07-29 | Traditional | PDF ↗ |
| K091911 | BOLUS COMPENSATOR | .Decimal, Inc. | 2009-07-21 | Special | PDF ↗ |
| K090417 | AXXENT FLEXISHIELD MINI | Xoft, Inc. | 2009-06-23 | Traditional | PDF ↗ |
| K071078 | .DECIMAL RANGE COMPENSATOR | .Decimal, Inc. | 2007-05-22 | Traditional | PDF ↗ |
| K071077 | .DECIMAL APERTURE | .Decimal, Inc. | 2007-05-18 | Traditional | PDF ↗ |
| K062781 | MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY | Symtium Corporation | 2006-11-21 | Traditional | PDF ↗ |
| K060187 | TOPSLANE DMLC | Topslane International, LLC | 2006-07-27 | Traditional | PDF ↗ |
| K052383 | INNOCURE IMRT FILTER (COMPENSATORS) | Innocure, LLC | 2006-03-29 | Traditional | PDF ↗ |
| K040804 | .DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR | Southeastern Radiation Products, Inc. | 2004-04-28 | Traditional | PDF ↗ |
| K040553 | MODIFICATION TO ACCULEAF | Direx Systems Corp. | 2004-04-01 | Special | PDF ↗ |
| K032790 | MICROMLC | Siemens Medical Solutions USA, Inc. | 2003-10-02 | Special | PDF ↗ |
| K030609 | MODULEAF | Mrc Systems GmbH | 2003-03-17 | Special | PDF ↗ |
| K021987 | PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY | S&S Par Scientific | 2002-12-27 | Traditional | PDF ↗ |
| K013875 | MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE | Med-Tec,Inc. | 2002-09-27 | Traditional | PDF ↗ |
| K011816 | MINI MULTILEAF COLLIMATOR, MODEL KMI | Mrc Systems GmbH | 2001-09-07 | Traditional | PDF ↗ |
| K010172 | LEAD BLOCKS | Arplay Medical S.A. | 2001-04-18 | Traditional | PDF ↗ |
| K001163 | DMLC IV-ERGO | 3D Line USA, Inc. | 2000-10-23 | Traditional | PDF ↗ |
| K000349 | MOTORIZED MICRO MULTILEAF COLLIMATOR | Stryker Leibinger | 2000-05-03 | Traditional | PDF ↗ |
| K000137 | ENHANCED COMPENSATING FILTER | Computerized Medical Systems, Inc. | 2000-04-17 | Traditional | PDF ↗ |
| K990491 | ANGIO-CT MIYABI | Siemens Medical Solutions USA, Inc. | 1999-04-05 | Traditional | PDF ↗ |
| K981992 | ELECTRON WEDGE MODEL MT-EW-1000 | Med-Tec,Inc. | 1998-12-15 | Traditional | PDF ↗ |
| K974239 | AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM | Aktina Medical Physics Corp. | 1998-02-10 | Traditional | PDF ↗ |
| K973953 | AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM | Aktina Medical Physics Corp. | 1998-01-14 | Traditional | PDF ↗ |
| K972016 | AUTIMO 2.5-D AND AUTIMO 3-D | C.L. Mcintosh & Assoc., Inc. | 1997-12-04 | Traditional | PDF ↗ |
| K971001 | AUTIMO | Medizintechnik, GmbH | 1997-06-13 | Traditional | PDF ↗ |
| K970303 | SATURNE MULTILEAF COLLIMATOR | General Electric Co. | 1997-04-25 | Traditional | PDF ↗ |
| K961902 | SIEMENS BEAM SHAPER | Siemens Medical Solutions USA, Inc. | 1996-08-08 | Traditional | PDF ↗ |
| K954248 | SIEMENS VIRTURAL WEDGE | Siemens Medical Solutions USA, Inc. | 1996-01-05 | Traditional | PDF ↗ |
| K953227 | CASPER | Northwest Medical Physics Center | 1995-11-22 | Traditional | PDF ↗ |
| K953894 | SIEMENS MULTILEAF COLLIMATOR | Siemens Medical Solutions USA, Inc. | 1995-11-13 | Traditional | PDF ↗ |
| K940412 | MULTILEAF INTENSITY MODULATING COLLIMATOR | Nomos Corp. | 1995-02-15 | Traditional | PDF ↗ |
| K943343 | FIELD ABUTMENT WEDGE | Medtec, Inc. | 1994-12-23 | Traditional | PDF ↗ |
| K941719 | 360 DEG. ROTATING 1/2 BEAM BLOCK | Medtec, Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K904124 | PHILIPS MULTILEAF COLLIMATOR (MLC) | Philips Medical Systems, Inc. | 1991-01-30 | Traditional | PDF ↗ |
| K901567 | THE HUESTIS COMPU-PLOTTER | Huestis Machine Corp. | 1990-05-31 | Traditional | PDF ↗ |
| K893464 | VARIAN MULTILEAF COLLIMATOR | Varian Assoc., Inc. | 1989-08-10 | Traditional | PDF ↗ |
| K883317 | DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST | S & S X-Ray Products, Inc. | 1989-04-26 | Traditional | PDF ↗ |
| K880047 | HUESTIS COMPU-FORMER | Huestis Machine Corp. | 1988-04-11 | Traditional | PDF ↗ |
| K860193 | PORTALCAST | Diacor, Inc. | 1986-01-30 | Traditional | PDF ↗ |
| K852353 | DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM | Thomson-Cgr Medical Corp. | 1985-08-07 | Traditional | PDF ↗ |
| K842615 | CLARK PRECISION BLOCK CUTTER, COOLING | Clark Research and Development, Inc. | 1984-09-04 | Traditional | PDF ↗ |
| K791178 | MYVACET 5-07, 7-00 AND 9-40 | Radiation Products Design, Inc. | 1979-09-17 | Traditional | PDF ↗ |
Product code IXI · Class II · Radiology. Data: openFDA.