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
- 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
- K250692GentleBeam (GB1000)2Cleared 510(K)
- K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)2Cleared 510(K)
- K230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)2Cleared 510(K)
- K213942Esteya2Cleared 510(K)
- K190255Sensus Healthcare TVM Balloon Applicator2Cleared 510(K)
- K182641Sensus IORT System2Cleared 510(K)
- K173425SRT-100+2Cleared 510(K)
- K172080Photoelectric Therapy System2Cleared 510(K)
- K162568INTRABEAM 6002Cleared 510(K)
- K153570Axxent Electronic Brachytherapy System Model 110 XP 12002Cleared 510(K)
- K150037Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities2Cleared 510(K)
- K141343AXXENT CERVICAL APPLICATOR2Cleared 510(K)
- K132092ESTEYA2Cleared 510(K)
- K131582SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM2Cleared 510(K)
- K130549INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR2Cleared 510(K)
- K123985SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-1002Cleared 510(K)
- K122951XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 1102Cleared 510(K)
- K121653INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS2Cleared 510(K)
- K110590INTRABEAM NEEDLE APPLICATOR2Cleared 510(K)
- K111299AXXENT RADIATION SHIELD - RIGID2Cleared 510(K)
- K090584INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS2Cleared 510(K)
- K090914AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E2Cleared 510(K)
- K083734AXXENT SURFACE APPLICATOR, MODEL 7102572Cleared 510(K)
- K072616AXXENT VAGINAL APPLICATOR2Cleared 510(K)
- K072683AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM2Cleared 510(K)
- K063456SRT100 SUPERFICIAL RADIATION THERAPY SYSTEM2Cleared 510(K)
- K050843AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM2Cleared 510(K)
- K051055INTRABEAM SYSTEM2Cleared 510(K)
- K992577PHOTON RADIOSURGERY SYSTEM (PRS)2Cleared 510(K)
- K980526PHOTON RADIOSURGERY SYSTEM PRS4002Cleared 510(K)
- K973315THERAPAX DXT 300 MODEL HF-3002Cleared 510(K)
- K964952VERIDOSE V (FIVE), MODEL NUMBER 37-7052Cleared 510(K)
- K964947PHOTON RADIOSURGERY SYSTEM (PRS)2Cleared 510(K)
- K971074THERAPAX SXT 1502Cleared 510(K)
- K962613DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM2Cleared 510(K)
- K935209INSTA-FLO2Cleared 510(K)
- K923584THERAPAX DXT 300 SERIES 32Cleared 510(K)
- K904005HUESTIS FLEXI-BOARD2Cleared 510(K)
- K903377COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION2Cleared 510(K)
- K894683FABFOAM #3022Cleared 510(K)
- K882484CMS RECORD AND VERIFY SYSTEM2Cleared 510(K)
- K874214S9 DISPLAY SYSTEM2Cleared 510(K)
- K871810PLAN-32 SOFTWARE2Cleared 510(K)
- K861431THERAPAX HT 150T2Cleared 510(K)
- K854609MEVAMATIC 32Cleared 510(K)
- K844424INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/102Cleared 510(K)
- K833560RTP-5100-5200-5300 & 54002Cleared 510(K)
- K813439RTP-50002Cleared 510(K)
- K811528RADIATION BOLUS2Cleared 510(K)
- K781084THERAPAX 150A2Cleared 510(K)
- K780278RADIATION THERAPY TREAT. PLAN. SYS.2Cleared 510(K)
- K780157RADIATION TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K771817EMI THERAPY SIMULATOR2Cleared 510(K)
- 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
AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K090914
- 510(k) Type
- Traditional
- Applicant
- Xoft, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent - With Limitations
- Decision Date
- 7/16/2009
- Days to Decision
- 106 days
- Submission Type
- Summary