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
- JAEMicrotron, Medical2Product Code
- JAICouch, Radiation Therapy, Powered2Product Code
- JAQSystem, Applicator, Radionuclide, Remote-Controlled2Product Code
- KPQSystem, Simulation, Radiation Therapy2Product Code
- K132944ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION2Cleared 510(K)
- K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS2Cleared 510(K)
- K101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER2Cleared 510(K)
- K090706ONCENTRA SIMULATION 2.32Cleared 510(K)
- K083591IKOENGELO, VERSION 22Cleared 510(K)
- K072445INTEGRATED BRACHYTHERAPY UNIT - DIGITAL2Cleared 510(K)
- K061006IKOENGELO2Cleared 510(K)
- K052361SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM2Cleared 510(K)
- K052345ADVANTAGE SIM MD2Cleared 510(K)
- K033470SIMULIX EVOLUTION2Cleared 510(K)
- K033339ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY2Cleared 510(K)
- K032550EXOMIO, MODEL 2.0 SP12Cleared 510(K)
- K023052ACUITY RADIATION THERAPY SIMULATOR2Cleared 510(K)
- K022219EXOMIO, MODEL 1.12Cleared 510(K)
- K021780ADVANTAGE SIM 6.02Cleared 510(K)
- K013531QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.002Cleared 510(K)
- K992751SOMAVISION2Cleared 510(K)
- K982857HELAX-IMCON, VERSION 1.02Cleared 510(K)
- K973848IBU, INTEGRATED BRACHY THERAPY UNIT2Cleared 510(K)
- K971839VARIAN RADIATION THERAPY IMAGING SYSTEM2Cleared 510(K)
- K964972SHADOWFORM2Cleared 510(K)
- K964138VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE2Cleared 510(K)
- K953233SIMVIEW 3000 CT OPTION2Cleared 510(K)
- K960737MODEL 555 010 XY CONVERSION(55010)2Cleared 510(K)
- K951830ADVANTAGE SIM2Cleared 510(K)
- K945838CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY2Cleared 510(K)
- K946128SIMULIX-HP2Cleared 510(K)
- K946053SIMVIEW(TM) 30002Cleared 510(K)
- K930213MODEL ASYM-1002Cleared 510(K)
- K921108CMS RECORD AND VERIFY2Cleared 510(K)
- K923851ACQSIM SIMULATOR/LOCALIZER2Cleared 510(K)
- K922287E.Z. PORT(TM) RADIATION THERAPY SKIN MARKERS2Cleared 510(K)
- K920506CONTOURING DEVICE2Cleared 510(K)
- K921876MKS BEAM OUTLINE PROJECTOR2Cleared 510(K)
- K914926SCANDIPLAN - VERSION 3382Cleared 510(K)
- K913017MODULEX RTP SYSTEM2Cleared 510(K)
- K903313RAHD 31002Cleared 510(K)
- K910647XIMATRON/CT OPTION2Cleared 510(K)
- K911340AUTOCOMP2Cleared 510(K)
- K912466OLDELFT SIMULIX-MC2Cleared 510(K)
- K910367COMPUTE-RX-COMP (TM)2Cleared 510(K)
- K896555CTS COMPUTED TOMOGRAPHY (CT) ATTACHMENT2Cleared 510(K)
- K894568NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM2Cleared 510(K)
- K896353GE TARGET SERIES 22Cleared 510(K)
- K895442THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL2Cleared 510(K)
- K884261PROWESS 20002Cleared 510(K)
- K891293SLS SIMULATOR (MODELS SLS-9 AND SLS-14)2Cleared 510(K)
- K884323XIMAVIEW(TM)2Cleared 510(K)
- K885081SIMRITE VERIFICATION AND SIMULATION SYSTEM2Cleared 510(K)
- K873580MHTI CT-SIM RADIATION THERAPY TREATMENT SIMULATOR2Cleared 510(K)
- K870221T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)2Cleared 510(K)
- K854880RADIATION BEAM DATA ACQUISTIOIN SYSTEMS2Cleared 510(K)
- K853671BEAMSCAN2Cleared 510(K)
- K853349VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST2Cleared 510(K)
- K852410MEVAPLAN AND SOMADOS2Cleared 510(K)
- K851813THERPAC-RADIATION THERAPY TREATMENT PLANNING SYSTE2Cleared 510(K)
- K850977COMPUTE RX-PLAN2Cleared 510(K)
- K851653VARIAN/XIMATRON 5 CARBON-FIBER COUCH TOP2Cleared 510(K)
- K834281RAD II SIMULATOR2Cleared 510(K)
- K812726KERMATH THERAPY SIMULATOR2Cleared 510(K)
- K810858XIMATRON V2Cleared 510(K)
- K803124SIDOS U.2Cleared 510(K)
- K803032PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.2Cleared 510(K)
- K782005RADIATION ONCOLOGY SYSTEM2Cleared 510(K)
- K781519EMI SIMULATOR REMOTE CONTROL CONSOLE2Cleared 510(K)
- K781496XIMATRON IV2Cleared 510(K)
- K780963X-RAY SYSTEM2Cleared 510(K)
- K770202CTM (CLINAC TREATMENT MONITOR)2Cleared 510(K)
- K761265VARIPLAN COMPUT. RADIOTHERAPY2Cleared 510(K)
- K760420FILTER, VACUUM LINE LINEGUARD2Cleared 510(K)
- 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
HELAX-IMCON, VERSION 1.0
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K982857
- 510(k) Type
- Traditional
- Applicant
- HELAX AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/4/1998
- Days to Decision
- 83 days
- Submission Type
- Summary