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
- 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
- K250064Dose+ (1.0)2Cleared 510(K)
- K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT2Cleared 510(K)
- K242992RayCare (2024A SP1)2Cleared 510(K)
- K242748Oncospace2Cleared 510(K)
- K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP32Cleared 510(K)
- K242822ART-Plan+ (v.3.0.0)2Cleared 510(K)
- K242463ARIA Radiation Therapy Management System (18.1)2Cleared 510(K)
- K242378Eclipse Treatment Planning System (18.1)2Cleared 510(K)
- K240671XBeam (v2)2Cleared 510(K)
- K243057TrueFit Bolus; TrueFlex Bolus2Cleared 510(K)
- K241876Vitesse (5.0)2Cleared 510(K)
- K241318Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)2Cleared 510(K)
- K233236Radiance V52Cleared 510(K)
- K232799syngo.via RT Image Suite2Cleared 510(K)
- K234068ART-Plan (v.2.2.0)2Cleared 510(K)
- K232479ART-Plan2Cleared 510(K)
- K231825Panther TPS2Cleared 510(K)
- K232400VariSeed (v10)2Cleared 510(K)
- K223724MOZI TPS2Cleared 510(K)
- K230557Eclipse Treatment Planning System (v18.0)2Cleared 510(K)
- K222728Radiation Planning Assistant (RPA)2Cleared 510(K)
- K222312RayStation 12A2Cleared 510(K)
- K223279RT Elements (4.0)2Cleared 510(K)
- K223233Monaco RTP System2Cleared 510(K)
- K222803Oncospace2Cleared 510(K)
- K220783syngo.via RT Image Suite2Cleared 510(K)
- K211841MRI Planner2Cleared 510(K)
- K220582ClearCalc Model RADCA V22Cleared 510(K)
- K213787Monaco RTP System2Cleared 510(K)
- K220141RayStation 11B2Cleared 510(K)
- K212274INT Contour2Cleared 510(K)
- K214081MRCAT Head & Neck2Cleared 510(K)
- K2134383D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory2Cleared 510(K)
- K211867RayStation 11.02Cleared 510(K)
- K211881AI Segmentation2Cleared 510(K)
- K211379syngo.via RT Image Suite2Cleared 510(K)
- K211511decimal Bolus2Cleared 510(K)
- K210645RayStation 10.12Cleared 510(K)
- K211034Corvus Radiation Therapy Planning System2Cleared 510(K)
- K203469AI Segmentation2Cleared 510(K)
- K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review2Cleared 510(K)
- K202284Oncospace2Cleared 510(K)
- K202789Monaco Rtp System2Cleared 510(K)
- K2037664D Integrated Treatment Console2Cleared 510(K)
- K200569RayStation2Cleared 510(K)
- K201350CORVUS2Cleared 510(K)
- K201444Syngo.via RT Image Suite2Cleared 510(K)
- K201607Eclipse Treatment Planning System v16.12Cleared 510(K)
- K200487RayCare 3.12Cleared 510(K)
- K193459Panther Stereotactic2Cleared 510(K)
- K193640ClearCalc2Cleared 510(K)
- K200608Eclipse Treatment Planning System v16.02Cleared 510(K)
- K193109MRCAT brain2Cleared 510(K)
- K193381RadCalc Software2Cleared 510(K)
- K192554decimal3D2Cleared 510(K)
- K192065Syngo.Via RT Image Suite2Cleared 510(K)
- K191384RayCare 2.32Cleared 510(K)
- K190387RayStation2Cleared 510(K)
- K182888MRCAT Pelvis2Cleared 510(K)
- K190664RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review2Cleared 510(K)
- K190178Monaco RTP System2Cleared 510(K)
- K182665Sensus TPS Workstation2Cleared 510(K)
- K183037Monaco RTP System2Cleared 510(K)
- K1802893D Bolus Software2Cleared 510(K)
- K181145Eclipse Treatment Planning System2Cleared 510(K)
- K173940Astroid Planning App2Cleared 510(K)
- K180379RayStation 72Cleared 510(K)
- K180308Prelude2Cleared 510(K)
- K173635syngo.via RT Image Suite2Cleared 510(K)
- K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review2Cleared 510(K)
- K172163Eclipse Treatment Planning System2Cleared 510(K)
- K171885Radiance V42Cleared 510(K)
- K170969Eclipse Treatment Planning System2Cleared 510(K)
- K171536RayStation2Cleared 510(K)
- K170355RayStation 62Cleared 510(K)
- K170086Pinnacle Radiation Therapy Planning System2Cleared 510(K)
- K162370syngo.via RT Image Suite2Cleared 510(K)
- K161136Precision Treatment Planning System2Cleared 510(K)
- K160093RayStation2Cleared 510(K)
- K151435MRCAT2Cleared 510(K)
- K153368Radiance V32Cleared 510(K)
- K143514Panther StereoSeed2Cleared 510(K)
- K151469CORVUS Radiation Therapy Planning System2Cleared 510(K)
- K152488Onrad Treatment System2Cleared 510(K)
- K152393Eclipse Treatment Planning System2Cleared 510(K)
- K151887syngo VSim2Cleared 510(K)
- K151560QuickPlan2Cleared 510(K)
- K151666Leksell GammaPlan2Cleared 510(K)
- K151380syngo.via RT Image Suite2Cleared 510(K)
- K151369.decimal p.d2Cleared 510(K)
- K151233Monaco2Cleared 510(K)
- K141900SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE2Cleared 510(K)
- K150547.decimal Astroid Dosimetry App2Cleared 510(K)
- K143269Delivery Analysis2Cleared 510(K)
- K142108RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS2Cleared 510(K)
- K141860RAYSTATION2Cleared 510(K)
- K141248SMART SEGMENTATION KNOWLEDGE BASED CONTOURING2Cleared 510(K)
- K141283ECLIPSE TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K132816ONCENTRA BRACHY2Cleared 510(K)
- K140187RAY STATION2Cleared 510(K)
- K133247ECLIPSE TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K133655RADIANCE V22Cleared 510(K)
- K1333314D INTEGRATED TREATMENT CONSOLE2Cleared 510(K)
- K132971MONACO2Cleared 510(K)
- K131891ECLIPSE TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K131428RADVISION2Cleared 510(K)
- K130617RAYSTATION2Cleared 510(K)
- K123263HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS2Cleared 510(K)
- K123357ONQ RTS2Cleared 510(K)
- K123152VITESSE 3.02Cleared 510(K)
- K121448ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY2Cleared 510(K)
- K120551SIMUPLAN TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K120387RAYSTATION2Cleared 510(K)
- K120363SYNGO RT INTERFACE2Cleared 510(K)
- K112723EPIGRAY2Cleared 510(K)
- K112060RADIANCE2Cleared 510(K)
- K112776TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER2Cleared 510(K)
- K113102ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING2Cleared 510(K)
- K111311SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING2Cleared 510(K)
- K112446TOMOTHERAPY TREATMENT SYSTEM2Cleared 510(K)
- K103515EQUAL DOSE2Cleared 510(K)
- K110730MONACO RTP SYSTEM2Cleared 510(K)
- K103246IPLAN RT2Cleared 510(K)
- K103146ISOGRAY TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K102915VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM2Cleared 510(K)
- K103093LEKSELL GAMMAPLAN2Cleared 510(K)
- K101220EXPLORER 4D TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K102216XIO RTP SYSTEM2Cleared 510(K)
- K102011ECLIPSE TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K101076PROWESS PANTHER PROARC, MODEL VERSION 5.02Cleared 510(K)
- K101119SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 10568642Cleared 510(K)
- K100056MEDCOM RT-VIEWER SYSTEM2Cleared 510(K)
- K100417XKNIFE 52Cleared 510(K)
- K100552RAYSTATION VERSION 1.02Cleared 510(K)
- K100092CORVUS RADIATION THERAPY PLANNING SYSTEM2Cleared 510(K)
- K093588EXPLORER 4D TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K093391SIMUPLAN TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K092928DOSE VOLUME HISTOGRAM (DVH) EVALUATOR2Cleared 510(K)
- K092132XIO RTP SYSTEM2Cleared 510(K)
- K090972LEKSELL GAMMAPLAN2Cleared 510(K)
- K091179MONACO RTP SYSTEM, VMAT OPTION2Cleared 510(K)
- K090893TIGRT TPS2Cleared 510(K)
- K091492MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K091145FLEXIPLAN 3D AND 3D+2Cleared 510(K)
- K090531RADCALC SOFTWARE, VERSION 6.02Cleared 510(K)
- K083502PANTHER REALART, MODEL 4.72Cleared 510(K)
- K090182MODULE INTEGRATED RADIOTHERAPY SYSTEM (MIRS)2Cleared 510(K)
- K091146MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM2Cleared 510(K)
- K083672P.D SOFTWARE2Cleared 510(K)
- K090808PINNACLE3 SMARTARC2Cleared 510(K)
- K083414RADIONICS XKNIFE HDRT SYSTEM2Cleared 510(K)
- K083264RAYAUTOPLAN 1.02Cleared 510(K)
- K082606COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS)2Cleared 510(K)
- K082642ONCENTRA RT VIEWER 1.02Cleared 510(K)
- K082221RAYDOSE2Cleared 510(K)
- K082005MODIFICATION TO HI-ART TREATMENT SYSTEM2Cleared 510(K)
- K081112FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K080888MODEIFICATION TO IPLAN RT DOSE2Cleared 510(K)
- K080601ERGO++ VERSION 1.72Cleared 510(K)
- K081281OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)2Cleared 510(K)
- K080929ONCENTRA GYN2Cleared 510(K)
- K073020ECLIPSE TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K071760MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K071938MONACO RTP SYSTEM2Cleared 510(K)
- K071873MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K063230INTEGRA RADIONICS IMAGEFUSION 32Cleared 510(K)
- K063482CROSSPLAN / ACCUSOFT-XL V.4.042Cleared 510(K)
- K062967CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM2Cleared 510(K)
- K062032ACCUSOFT, ACCUSOFT XL2Cleared 510(K)
- K062514CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM2Cleared 510(K)
- K061893INTEGRA RADIONICS XKNIFE RT 42Cleared 510(K)
- K053584IPLAN RT DOSE2Cleared 510(K)
- K061440P.D2Cleared 510(K)
- K061097COHERENCE DOSIMETRIST, MODEL 2.22Cleared 510(K)
- K050296ECLIPSE TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K052325CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY2Cleared 510(K)
- K051941CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM2Cleared 510(K)
- K051497VITESSE 2.02Cleared 510(K)
- K041971WIMRT MODULE FOR ARTP PLANNING SYSTEM2Cleared 510(K)
- K042861ODYSSEY2Cleared 510(K)
- K042739HI-ART SYSTEM2Cleared 510(K)
- K042269LEKSELL GAMMAPLAN 4C WITH MULTIVIEW2Cleared 510(K)
- K041997RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE2Cleared 510(K)
- K041403ECLIPSE WITH AAA2Cleared 510(K)
- K031088TRIMED PLAN, VERSION 2.22Cleared 510(K)
- K041719ONCENTRA-VISIR2Cleared 510(K)
- K040474ACCUSOFT2Cleared 510(K)
- K040688STANDARD IMAGING E.IMRT CALCULATOR2Cleared 510(K)
- K031281ERGO SRS2Cleared 510(K)
- K032456PROWESS2Cleared 510(K)
- K032724PINNACLE3 RADIATION THERAPY PLANNING SYSTEM2Cleared 510(K)
- K030821SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.52Cleared 510(K)
- K032345CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY2Cleared 510(K)
- K032209NOMOS CORVUS 5.0M2Cleared 510(K)
- K031349OTP 1.22Cleared 510(K)
- K022961RTDOSEPLAN2Cleared 510(K)
- K022036SIEMENS VIRTUAL SIMULATION (VSIM)2Cleared 510(K)
- K022741SPOT PRO (220V), MODEL 131.0992Cleared 510(K)
- K022307KONRAD, MODEL V.2.02Cleared 510(K)
- K020027FOCUS RADIATION TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K022411PRECISEPLAN 2.02Cleared 510(K)
- K013644ACQPLAN 5.02Cleared 510(K)
- K020971DCM 2.02Cleared 510(K)
- K021268ECLIPSE, HELIOS OPTION2Cleared 510(K)
- K012575PREFERNCE IMRT TREATMENT PLANNING MODULE2Cleared 510(K)
- K013673HI-ART SYSTEM2Cleared 510(K)
- K013535EVTOOL MODEL # V. 1.02Cleared 510(K)
- K013112FOCAL SIM2Cleared 510(K)
- K013661XPLAN 2.2 WITH THE BODY SYSTEM2Cleared 510(K)
- K002132ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS2Cleared 510(K)
- K012017VARISEED 7.02Cleared 510(K)
- K010682HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K011246DCM 1.02Cleared 510(K)
- K010784PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.12Cleared 510(K)
- K002237P3IMRT TM2Cleared 510(K)
- K002509NOVALIS (SHAPED BEAM SURGERY SYSTEM)2Cleared 510(K)
- K001295PIPER2Cleared 510(K)
- K002147FOCUS2Cleared 510(K)
- K993675PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM2Cleared 510(K)
- K002312PROTON VISION 7.02Cleared 510(K)
- K002240RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.02Cleared 510(K)
- K994413BRAINSCAN2Cleared 510(K)
- K001700XPLAN 2.12Cleared 510(K)
- K993895OPTIRAD2Cleared 510(K)
- K000922PROTON VISION2Cleared 510(K)
- K993923ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM2Cleared 510(K)
- K992303SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.02Cleared 510(K)
- K992762BRACHYVISION 6.02Cleared 510(K)
- K992434ITP, MODEL 1.02Cleared 510(K)
- K993766HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K990475TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.52Cleared 510(K)
- K992864RENDER-PLAN 3-D2Cleared 510(K)
- K992753CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K991237XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL2Cleared 510(K)
- K991815EXPLORER 3D2Cleared 510(K)
- K984532CADPLAN HELIOS OPTION 6.02Cleared 510(K)
- K983343PLATO BRACHYTHERAPHY, MODEL V. 14.02Cleared 510(K)
- K982696INTERPLANT2Cleared 510(K)
- K990071IMAGEFUSION 2.02Cleared 510(K)
- K982791ROCS TPS2Cleared 510(K)
- K984196MODIFICATION TO PROWESS PRO-SIM2Cleared 510(K)
- K981678STRATA, MODEL V.O.952Cleared 510(K)
- K982821MMS THERPACPLUS B3DTUI MODEL NUMBER 6.72Cleared 510(K)
- K974770ACQPLAN2Cleared 510(K)
- K915691FOCUS RTP2Cleared 510(K)
- 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
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K002509
- 510(k) Type
- Traditional
- Applicant
- BRAINLAB AG
- Country
- Germany
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/3/2000
- Days to Decision
- 80 days
- Submission Type
- Summary