Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- FCDBarium Enema Kit1Product Code
- ITZAssembly, Tube Housing, X-Ray, Therapeutic2Product Code
- IWASource, Wire, Iridium, Radioactive2Product Code
- IWBSystem, Radiation Therapy, Radionuclide2Product Code
- IWDDevice, Beam Limiting, Teletherapy, Radionuclide2Product Code
- IWEMonitor, Patient Position, Light-Beam1Product Code
- IWFNeedle, Isotope, Gold, Titanium, Platinum2Product Code
- IWGSeed, Isotope, Gold, Titanium, Platinum2Product Code
- IWHSource, Teletherapy, Radionuclide1Product Code
- IWISource, Isotope, Sealed, Gold, Titanium, Platinum2Product Code
- IWJSystem, Applicator, Radionuclide, Manual1Product Code
- IWKCyclotron, Medical2Product Code
- IWLSystem, Radiation Therapy, Neutron, Medical2Product Code
- IWMSynchrotron, Medical2Product Code
- IXIBlock, Beam-Shaping, Radiation Therapy2Product Code
- K222639VHA Radiotherapy Bolus2Cleared 510(K)
- K214093VSP Bolus2Cleared 510(K)
- K132236.DECIMAL PROTON APERTURE2Cleared 510(K)
- K131150CURA COMPENSATOR2Cleared 510(K)
- K123893CURA COLLIMATOR2Cleared 510(K)
- K123015.DECIMAL PHOTON BLOCK2Cleared 510(K)
- K111676APEX2Cleared 510(K)
- K111759.DECIMAL ELECTRON APERTURE2Cleared 510(K)
- K091403MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY2Cleared 510(K)
- K091911BOLUS COMPENSATOR2Cleared 510(K)
- K090417AXXENT FLEXISHIELD MINI2Cleared 510(K)
- K071078.DECIMAL RANGE COMPENSATOR2Cleared 510(K)
- K071077.DECIMAL APERTURE2Cleared 510(K)
- K062781MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY2Cleared 510(K)
- K060187TOPSLANE DMLC2Cleared 510(K)
- K052383INNOCURE IMRT FILTER (COMPENSATORS)2Cleared 510(K)
- K040804.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR2Cleared 510(K)
- K040553MODIFICATION TO ACCULEAF2Cleared 510(K)
- K032790MICROMLC2Cleared 510(K)
- K030609MODULEAF2Cleared 510(K)
- K021987PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY2Cleared 510(K)
- K013875MED-TEC COMPENSATOR BLOCK CUTTER SOFTWARE2Cleared 510(K)
- K011816MINI MULTILEAF COLLIMATOR, MODEL KMI2Cleared 510(K)
- K010172LEAD BLOCKS2Cleared 510(K)
- K001163DMLC IV-ERGO2Cleared 510(K)
- K000349MOTORIZED MICRO MULTILEAF COLLIMATOR2Cleared 510(K)
- K000137ENHANCED COMPENSATING FILTER2Cleared 510(K)
- K990491ANGIO-CT MIYABI2Cleared 510(K)
- K981992ELECTRON WEDGE MODEL MT-EW-10002Cleared 510(K)
- K974239AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM2Cleared 510(K)
- K973953AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM2Cleared 510(K)
- K972016AUTIMO 2.5-D AND AUTIMO 3-D2Cleared 510(K)
- K971001AUTIMO2Cleared 510(K)
- K970303SATURNE MULTILEAF COLLIMATOR2Cleared 510(K)
- K961902SIEMENS BEAM SHAPER2Cleared 510(K)
- K954248SIEMENS VIRTURAL WEDGE2Cleared 510(K)
- K953227CASPER2Cleared 510(K)
- K953894SIEMENS MULTILEAF COLLIMATOR2Cleared 510(K)
- K940412MULTILEAF INTENSITY MODULATING COLLIMATOR2Cleared 510(K)
- K943343FIELD ABUTMENT WEDGE2Cleared 510(K)
- K941719360 DEG. ROTATING 1/2 BEAM BLOCK2Cleared 510(K)
- K904124PHILIPS MULTILEAF COLLIMATOR (MLC)2Cleared 510(K)
- K901567THE HUESTIS COMPU-PLOTTER2Cleared 510(K)
- K893464VARIAN MULTILEAF COLLIMATOR2Cleared 510(K)
- K883317DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST2Cleared 510(K)
- K880047HUESTIS COMPU-FORMER2Cleared 510(K)
- K860193PORTALCAST2Cleared 510(K)
- K852353DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM2Cleared 510(K)
- K842615CLARK PRECISION BLOCK CUTTER, COOLING2Cleared 510(K)
- K791178MYVACET 5-07, 7-00 AND 9-402Cleared 510(K)
- IYCGenerator, Orthovoltage, Therapeutic X-Ray2Product Code
- IYDGenerator, Low Voltage, Therapeutic X-Ray2Product Code
- IYEAccelerator, Linear, Medical2Product Code
- IYGBetatron, Medical2Product Code
- IYHGenerator, Dermatological (Grenz Ray), Therapeutic X-Ray2Product Code
- IYICollimator, Orthovoltage, Therapeutic X-Ray2Product Code
- IYJCollimator, Low Voltage, Therapeutic X-Ray2Product Code
- IYKCollimator, High Voltage, Therapeutic X-Ray2Product Code
- IYLCollimator, Dermatological, Therapeutic X-Ray2Product Code
- JADSystem, Therapeutic, X-Ray2Product Code
- JAEMicrotron, Medical2Product Code
- JAICouch, Radiation Therapy, Powered2Product Code
- JAQSystem, Applicator, Radionuclide, Remote-Controlled2Product Code
- KPQSystem, Simulation, Radiation Therapy2Product Code
- KPZGenerator, High Voltage, X-Ray, Therapeutic2Product Code
- KQADevice, Beam Limiting, X-Ray, Therapeutic2Product Code
- KXKSource, Brachytherapy, Radionuclide2Product Code
- LHNSystem, Radiation Therapy, Charged-Particle, Medical2Product Code
- MUJSystem, Planning, Radiation Therapy Treatment2Product Code
- MWWAccessory - Film Dosimetry System2Product Code
- NMPNeedle, Isotope, Reprocessed2Product Code
- NZTDosimeter, Ionizing Radiation, Implanted2Product Code
- OINProstate Seeding Kit2Product Code
- ONLConformal Brachytherapy Source2Product Code
- OVBHydrogel Spacer2Product Code
- PCTProstate Immobilizer Rectal Balloon2Product Code
- RGCX-Ray Field Indicator Light (Laser)1Product Code
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
MODIFICATION TO ACCULEAF
- Page Type
- Cleared 510(K)
- 510(k) Number
- K040553
- 510(k) Type
- Special
- Applicant
- DIREX SYSTEMS CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/1/2004
- Days to Decision
- 30 days
- Submission Type
- Summary