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
- K250696AccuCheck2Cleared 510(K)
- K250911MOSkin Radiation Measurement System2Cleared 510(K)
- K252948TrueBeam, TrueBeam STX, Edge and VitalBeam2Cleared 510(K)
- K252174AquaCast Mask2Cleared 510(K)
- K243142Cranial 4Pi Immobilization2Cleared 510(K)
- K243301MapRT2Cleared 510(K)
- K250099Mobius3D (4.1)2Cleared 510(K)
- K250429DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set2Cleared 510(K)
- K241937Klarity SGRT System (ARSG-E1A, ARSG-E3A)2Cleared 510(K)
- K242957Identify (4.0)2Cleared 510(K)
- K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface2Cleared 510(K)
- K232738BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)2Cleared 510(K)
- K232923Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)2Cleared 510(K)
- K232489VenusX2Cleared 510(K)
- K233622AlignRT Plus2Cleared 510(K)
- K232031LUNA 3D2Cleared 510(K)
- K231573ThinkQA (Edition 2)2Cleared 510(K)
- K223234Delta4 Insight2Cleared 510(K)
- K231273ArcherQA (V1.0)2Cleared 510(K)
- K232293kallisio stentra™ oral stent2Cleared 510(K)
- K232870TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)2Cleared 510(K)
- K231852BinkieRT2Cleared 510(K)
- K232113Halcyon, Ethos Radiotherapy System2Cleared 510(K)
- K231317TrueBeam, TrueBeam STx, Edge, VitalBeam2Cleared 510(K)
- K230576IDENTIFY2Cleared 510(K)
- K223834AccuCheck2Cleared 510(K)
- K231185MapRT2Cleared 510(K)
- K223159Radixact Treatment Delivery System2Cleared 510(K)
- K222762SIDDHARTH-II;IMPACT2Cleared 510(K)
- K223839TrueBeam, TrueBeam STx, Edge, VitalBeam2Cleared 510(K)
- K231052ExacTrac Dynamic 1.1.22Cleared 510(K)
- K230699ARIA Radiation Therapy Management (v18.0)2Cleared 510(K)
- K230312Iris AirShuttle™2Cleared 510(K)
- K223229MOSAIQ® OIS (Oncology Information System)2Cleared 510(K)
- K223209Elekta Unity2Cleared 510(K)
- K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip2Cleared 510(K)
- K222941Halcyon, Ethos Radiotherapy System2Cleared 510(K)
- K220539Klarity SRS Baseplate, Klarity Promise Baseplate2Cleared 510(K)
- K220583ClearCheck Model RADCC V22Cleared 510(K)
- K213439FlexBoardTM, EagleBoardTM, BreastBoard SXTM2Cleared 510(K)
- K221408ARIA Radiation Therapy Management (v16.1 MR3)2Cleared 510(K)
- K221448ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)2Cleared 510(K)
- K213977TrueBeam, TrueBeam STx, Edge, VitalBeam2Cleared 510(K)
- K213137INTDose2Cleared 510(K)
- K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips2Cleared 510(K)
- K213526Aurora-RT2Cleared 510(K)
- K220338ExacTrac Dynamic2Cleared 510(K)
- K213370VERIQA2Cleared 510(K)
- K213053Gold Anchor2Cleared 510(K)
- K212958MRIdian Linac System2Cleared 510(K)
- K212583AlignRT Plus2Cleared 510(K)
- K210921TaiChiB2Cleared 510(K)
- K212114Elekta Unity2Cleared 510(K)
- K212794Accuray Precision Treatment Planning System2Cleared 510(K)
- K211760Panther OIS2Cleared 510(K)
- K210894SIDDHARTH-II; IMPACT2Cleared 510(K)
- K212606BeamSite2Cleared 510(K)
- K203722RayPilot System2Cleared 510(K)
- K212294Ethos Treatment Management, Ethos Treatment Planning2Cleared 510(K)
- K211663Zap-X Radiosurgical System2Cleared 510(K)
- K211939ExacTrac Dynamic2Cleared 510(K)
- K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD2Cleared 510(K)
- K211590Fiducial Marker2Cleared 510(K)
- K211001C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner2Cleared 510(K)
- K202747Klarity Bolus2Cleared 510(K)
- K210835Identify2Cleared 510(K)
- K203387AlignRT Plus2Cleared 510(K)
- K203669Mobius3D2Cleared 510(K)
- K203172MOSAIQ Oncology Information System2Cleared 510(K)
- K202412ClearRT Helical kVCT for the Radixact Treatment Delivery System2Cleared 510(K)
- K200940BeamSite2Cleared 510(K)
- K203173ExacTrac Dynamic2Cleared 510(K)
- K202050Cranial 4Pi Immobilization2Cleared 510(K)
- K202068The AIO Solution 3.02Cleared 510(K)
- K193207TaiChiA2Cleared 510(K)
- K201276ExacTrac Dynamic2Cleared 510(K)
- K200652Lollipop BiteBlock2Cleared 510(K)
- K201119ChartCheck2Cleared 510(K)
- K201117Gold Anchor2Cleared 510(K)
- K200907Thales 3D Mr Scanner2Cleared 510(K)
- K200435Catalyst+, Catalyst+ HD2Cleared 510(K)
- K192405Image Guidance System for Radiotherapy2Cleared 510(K)
- K200600Sentinel2Cleared 510(K)
- K190978RefleXion Medical Radiotherapy System2Cleared 510(K)
- K193243Alta Multipurpose Device2Cleared 510(K)
- K191646Beamscan MR2Cleared 510(K)
- K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon2Cleared 510(K)
- K193431AlignRT Plus2Cleared 510(K)
- K192196Medical Radiation Dosimetry System microSTARii2Cleared 510(K)
- K192482Elekta Unity2Cleared 510(K)
- K192242Synergy Platform, Synergy, Infinity, VersaHD2Cleared 510(K)
- K192968IDENTIFY2Cleared 510(K)
- K191944MU2net2Cleared 510(K)
- K192424Mobius3D2Cleared 510(K)
- K192102Thermoplastic Masks2Cleared 510(K)
- K191158The AIO Solution2Cleared 510(K)
- K191267ImagingRing System on Rails2Cleared 510(K)
- K191761Mobius3D2Cleared 510(K)
- K191797BiomarC Fiducial Marker2Cleared 510(K)
- K190137Identify2Cleared 510(K)
- K182374LIAC S2Cleared 510(K)
- K190894TOTIM Patient Cushion Immobilization System2Cleared 510(K)
- K183606Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)2Cleared 510(K)
- K190155FibermarX Radiopaque Tissue Marker2Cleared 510(K)
- K183374GrayDuck Stent2Cleared 510(K)
- K183698Zap-X Radiosurgery System2Cleared 510(K)
- K181989MRIdian Linac System2Cleared 510(K)
- K183034MOSAIQ Oncology Information System2Cleared 510(K)
- K182076Elekta Unity2Cleared 510(K)
- K182687Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System2Cleared 510(K)
- K182189Encompass SRS Headframe ; Encompass MR SRS Headframe2Cleared 510(K)
- K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch2Cleared 510(K)
- K173926DORADOnova MR3T2Cleared 510(K)
- K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask2Cleared 510(K)
- K182138Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD2Cleared 510(K)
- K181218AlignRT Plus2Cleared 510(K)
- K173848Model WP-3840 and WP-30402Cleared 510(K)
- K180027ACCUSYTE 3D Fiducial Marker2Cleared 510(K)
- K180697Pseudo-Patient2Cleared 510(K)
- K180021Proton Positioing and Immobilization Devices2Cleared 510(K)
- K181404Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator2Cleared 510(K)
- K172961LIAC HWL2Cleared 510(K)
- K181032Halcyon2Cleared 510(K)
- K170570Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung2Cleared 510(K)
- K180595SciMoCa2Cleared 510(K)
- K180586Varian Head Frame2Cleared 510(K)
- K180106ThinkQA2Cleared 510(K)
- K173838ARIA Radiation Therapy Management2Cleared 510(K)
- K173251LumiCoil Platinum Fiducial Marker2Cleared 510(K)
- K171352EZFluence2Cleared 510(K)
- K171350Collision Check2Cleared 510(K)
- K171467BioZorb Marker GOLD / LP Marker GOLD2Cleared 510(K)
- K172534LINACwatch, LinacView2Cleared 510(K)
- K170345SOFTDISO2Cleared 510(K)
- K170307SunCHECK2Cleared 510(K)
- K160405OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D2Cleared 510(K)
- K171804Zap-X Radiosurgery System2Cleared 510(K)
- K172013VitalBeam2Cleared 510(K)
- K171837TomoTherapy Treatment Delivery System with iDMS2Cleared 510(K)
- K171734HP PRO Positioning Device2Cleared 510(K)
- K171733TrueBeam, TrueBeam STx, Edge2Cleared 510(K)
- K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories2Cleared 510(K)
- K170817Halcyon2Cleared 510(K)
- K171086Accuray Precision Treatment Planning System2Cleared 510(K)
- K170751MRIdian Linac System with 138-leaf Collimator2Cleared 510(K)
- K161807BEAMSCAN2Cleared 510(K)
- K161724Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded)2Cleared 510(K)
- K170788CyberKnife Treatment Delivery System2Cleared 510(K)
- K170058TheraView TBI2Cleared 510(K)
- K162393The ViewRay (MRIdian) Linac System2Cleared 510(K)
- K162472TrueBeam-TrueBeam STx-Edge2Cleared 510(K)
- K162476Varian High Energy Linear Accelerator2Cleared 510(K)
- K161400ImagingRing System2Cleared 510(K)
- K162468ClearCheck2Cleared 510(K)
- K162355Raycast MammoRx Carbon Fibre Breast Board2Cleared 510(K)
- K162577Dosimetry Check Version 5 Release 12Cleared 510(K)
- K162265CushionCast Moldable Cushions2Cleared 510(K)
- K162862Raycast High Precision Lung Board Solution2Cleared 510(K)
- K162002Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay2Cleared 510(K)
- K162629IQM Integral Quality Monitor (also IQM)2Cleared 510(K)
- K161984Interlocked Circular Small Field Collimators, Elekta Integrated2Cleared 510(K)
- K161946DoseCHECK2Cleared 510(K)
- K161146Radixact Treatment Delivery System2Cleared 510(K)
- K161144iDMS Data Management System2Cleared 510(K)
- K160209Gold Anchor2Cleared 510(K)
- K160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution2Cleared 510(K)
- K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement2Cleared 510(K)
- K160057ArcCHECK-MR2Cleared 510(K)
- K153014Mobius3D2Cleared 510(K)
- K153270TruGuard Custom Tongue and Jaw Positioner2Cleared 510(K)
- K152994Adaptivo2Cleared 510(K)
- K151426ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+2Cleared 510(K)
- K153011iViewDose R1.02Cleared 510(K)
- K152321kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening2Cleared 510(K)
- K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G)2Cleared 510(K)
- K142617ArcCHECK2Cleared 510(K)
- K151946Thermofit2Cleared 510(K)
- K151882Varian Treatment (VTx)2Cleared 510(K)
- K152867MHI-TM2000 Linear Accelerator System, VERO, Imavis2Cleared 510(K)
- K143560CygneX I System2Cleared 510(K)
- K150382Radio Therapy Treatment Chair2Cleared 510(K)
- K150265Model 206 Electrometer/Dosimeter2Cleared 510(K)
- K151180ScandiDos Delta4 Phantom+2Cleared 510(K)
- K150767EDOSE2Cleared 510(K)
- K151207Proton Immobilization Solution2Cleared 510(K)
- K150873CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System2Cleared 510(K)
- K150848Dose Calculator2Cleared 510(K)
- K151097Active Breathing Coordinator2Cleared 510(K)
- K150706VitalBeam2Cleared 510(K)
- K142420Patient Positioning Devices2Cleared 510(K)
- K142294FlexiMarc Marker2Cleared 510(K)
- K143485iGuide 2.12Cleared 510(K)
- K143224TrueBeam-TrueBeam STx-Edge2Cleared 510(K)
- K142560Varian Head Frame2Cleared 510(K)
- K142431WaterProof PROFILER2Cleared 510(K)
- K142142QUALITY REPORTS2Cleared 510(K)
- K142434ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR12Cleared 510(K)
- K141855CLARITY2Cleared 510(K)
- K142268Varian Verification System (VVS)2Cleared 510(K)
- K141800PERFRACTION2Cleared 510(K)
- K141572MOSAIQ ONCOLOGY INFORMATION SYSTEM2Cleared 510(K)
- K140528TRUE BEAM, TRUE BEAM STX, EDGE2Cleared 510(K)
- K141230DOSELAB PRO2Cleared 510(K)
- K141787SAGITTILT2Cleared 510(K)
- K140823PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER2Cleared 510(K)
- K140660MOBIUS3D2Cleared 510(K)
- K133572ARIA RADIATION THERAPY MANAGEMENT2Cleared 510(K)
- K133227SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING2Cleared 510(K)
- K132908TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT2Cleared 510(K)
- K132064BIOMARC FIDUCIAL MARKER2Cleared 510(K)
- K132935ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME2Cleared 510(K)
- K133240VARIAN MULTILEAF COLLIMATOR2Cleared 510(K)
- K132605DOSIMETRY CHECK VERSION 4 RELEASE 12Cleared 510(K)
- K132124KLARITY VACUUM BAG, KLARITY MOLD CUSHION2Cleared 510(K)
- K132705UNIQUE2Cleared 510(K)
- K131807HIGH ENERGY LINEAR ACCELERATOR2Cleared 510(K)
- K131795NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS2Cleared 510(K)
- K131965XVI R5.02Cleared 510(K)
- K1318623DVH2Cleared 510(K)
- K131466MAPCHECK2, ARCCHECK2Cleared 510(K)
- K131313ACTIVE BREATHING COORDINATOR2Cleared 510(K)
- K131704EPIDOSE2Cleared 510(K)
- K130992PINNACLE3 RADIATION THERAPY PLANNING SYSTEM2Cleared 510(K)
- K121284CHABNER XRT GARMENTS2Cleared 510(K)
- K122888CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM2Cleared 510(K)
- K130678BIOMARC GOLD FIDUCIAL MARKER2Cleared 510(K)
- K123808AGILITY2Cleared 510(K)
- K123812COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV2Cleared 510(K)
- K123788INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)2Cleared 510(K)
- K123371ALIGNRT PLUS2Cleared 510(K)
- K122616PANTHER OIS/R & V MODEL VERSION 2.02Cleared 510(K)
- K123291TRUEBEAM2Cleared 510(K)
- K123230MOSAIQ ONCOLOGY INFORMATION SYSTEM2Cleared 510(K)
- K123137CALYPSO SYSTEM2Cleared 510(K)
- K121663CLARITY2Cleared 510(K)
- K122137CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM2Cleared 510(K)
- K121657PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY BEAM-SHPING RANGE COMPENSATOR2Cleared 510(K)
- K121845SDX SYSTEM2Cleared 510(K)
- K122450MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS2Cleared 510(K)
- K122451EXACTRAC VERO2Cleared 510(K)
- K121934TOMOTHERAPY TREATMENT SYSTEM2Cleared 510(K)
- K120789EXACTRAC X-RAY X-RAY2Cleared 510(K)
- K112692IDENTIFY2Cleared 510(K)
- K120668SENTINEL2Cleared 510(K)
- K121295ARTISTETM SOLUTION WITH SYS VCIO2Cleared 510(K)
- K121530BODYFIX SYSTEM2Cleared 510(K)
- K121328AGILITY2Cleared 510(K)
- K111862VIEWRAY SYSTEM2Cleared 510(K)
- K120335EMBRACE THERMOPLASTIC2Cleared 510(K)
- K112286NOVAC 112Cleared 510(K)
- K110840LIAC2Cleared 510(K)
- K120233SYNCHRONY RESPIRATORY TRACKING SYSTEM2Cleared 510(K)
- K120067MOSAIQ ONCOLOGY INFORMATION SYSTEM2Cleared 510(K)
- K113276CATALYST2Cleared 510(K)
- K112841SURFACE BEACON TRANSPONDERS2Cleared 510(K)
- K111332CLARITY OBP SYSTEM2Cleared 510(K)
- K113758VOLUSON E6/E8/E8EXPERT/E102Cleared 510(K)
- K110971TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT2Cleared 510(K)
- K112778SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING2Cleared 510(K)
- K112613INTEGRITY(TM)2Cleared 510(K)
- K112210FRAXION2Cleared 510(K)
- K112839VARIAN HIGH ENERGY LINEAR ACCELERATOR2Cleared 510(K)
- K112460MULTIPLE2Cleared 510(K)
- K111106TRUEBEAM2Cleared 510(K)
- K110772BIOMARC FIDUCIAL MARKER2Cleared 510(K)
- K103606ARTISTE SOLUTION WITH SYS_VB50 UPDATE2Cleared 510(K)
- K103616PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER2Cleared 510(K)
- K100625REALEYE MODEL VCPS2Cleared 510(K)
- K103394BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)2Cleared 510(K)
- K103193DOSEVIEW 3D2Cleared 510(K)
- K102765PRONEX2Cleared 510(K)
- K102237PVS MODEL 1.02Cleared 510(K)
- K102650CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM2Cleared 510(K)
- K102200INTEGRITY MODEL 10142842Cleared 510(K)
- K102583MUCHECK, VERSION 9.02Cleared 510(K)
- K102024RPM RESPIRATORY GATING SYSTEM2Cleared 510(K)
- K102671SYNGO RT THERAPIST CONNECT WORKSPACE, V4.22Cleared 510(K)
- K1019923D SCANNER, MODEL 12302Cleared 510(K)
- K101751VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR2Cleared 510(K)
- K101503DUSIMETRY CHECK2Cleared 510(K)
- K100890VARIAN HIGH ENERGY LINEAR ACCELERATOR2Cleared 510(K)
- K093967VARIAN TREATMENT2Cleared 510(K)
- K100801PUMA MODEL VERSION 1.02Cleared 510(K)
- K101131FIDUCIAL MARKERS2Cleared 510(K)
- K100691OMNI V SBRT POSITIONING SYSTEM, MODEL RT-45002Cleared 510(K)
- K100096LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART2Cleared 510(K)
- K100264T-FORM EXTREMITY IMMOBILIZER, MODEL RT-60602Cleared 510(K)
- K100115XVI R4.52Cleared 510(K)
- K092424P-ART, MODEL 0012Cleared 510(K)
- K100267FLEXIMARC, MODEL CM-0.9-2-10-GG-L2Cleared 510(K)
- K092845RESPISENS2Cleared 510(K)
- K092479SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL2Cleared 510(K)
- K093527ARIA RADIATION ONCOLOGY WITH MIRS2Cleared 510(K)
- K092550TIGRT IVS2Cleared 510(K)
- K092871TRILOGY MX2Cleared 510(K)
- K092939PATLOG 2.02Cleared 510(K)
- K092041STELLAR FIDUCIAL MARKER, MODEL GFMIA2Cleared 510(K)
- K092145160MLC OPTION2Cleared 510(K)
- K092018OMNIPRO INCLINE2Cleared 510(K)
- K091999CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM2Cleared 510(K)
- K092019MODEL 1014 PC ELECTROMETER2Cleared 510(K)
- K092285PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-902Cleared 510(K)
- K091645GOLD ANCHOR2Cleared 510(K)
- K090802TIGRT MLC, TIGRT DMLC2Cleared 510(K)
- K091209PORTALVISION ADVANCED IMAGING2Cleared 510(K)
- K091602MUCHECK V82Cleared 510(K)
- K0911324D INTEGRATED TREATMENT CONSOLE2Cleared 510(K)
- K090683SYNGO RT THERAPIST CONNECT2Cleared 510(K)
- K082582SENTINEL, MODEL SP-0012Cleared 510(K)
- K090349CLEARVUE PRONE BREAST TREATMENT TABLE2Cleared 510(K)
- K082775PRESCISION OPTION2Cleared 510(K)
- K090044PATLOG, PATLOG PATIENT HANDLING SYSTEM, PATLOG TOPLOG TABLE TOP, MODEL(S) 1.0, 1.0, C2Cleared 510(K)
- K082909RSVP HALF SPHERE PHANTOM, MODEL DDP0102Cleared 510(K)
- K082773STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 913312Cleared 510(K)
- K081935STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-1002Cleared 510(K)
- K082122MLCI22Cleared 510(K)
- K081859MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM2Cleared 510(K)
- K081760RSVP PHANTOM PELVIS, MODEL TLP2602Cleared 510(K)
- K081218BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST2Cleared 510(K)
- K081188TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE2Cleared 510(K)
- K080585DESKTOP PRO2Cleared 510(K)
- K080072MRI PATIENT POSITIONING DEVICES2Cleared 510(K)
- K080726CALYPSO 4D LOCALIZATION SYSTEM2Cleared 510(K)
- K0810364D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS)2Cleared 510(K)
- K080742VERISUITE 1.6, VERISUITE-PARTICLE 1.62Cleared 510(K)
- K073018STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT2Cleared 510(K)
- K072485ARTISTE MV SA2Cleared 510(K)
- K073273EQUAL DOSE 1.02Cleared 510(K)
- K072374COMPASS2Cleared 510(K)
- K072916TRILOGY SYSTEM WITH RAPIDARC2Cleared 510(K)
- K072529TRACKPORT2Cleared 510(K)
- K072506EXACTRAC 5.52Cleared 510(K)
- K072046EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM2Cleared 510(K)
- K072454INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS2Cleared 510(K)
- K072171GATECT-RT2Cleared 510(K)
- K072504CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM2Cleared 510(K)
- K071614FIDUCIAL MARKERS2Cleared 510(K)
- K072047MHI-TM2000 LINEAR ACCELERATOR SYSTEM2Cleared 510(K)
- K071531MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM2Cleared 510(K)
- K071992HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)2Cleared 510(K)
- K072079IGUIDE SYSTEM2Cleared 510(K)
- K071701TRACKLEAF-102Cleared 510(K)
- K071673ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 0010322Cleared 510(K)
- K070611BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 62Cleared 510(K)
- K071360OPTICAL GUIDANCE PLATFORM2Cleared 510(K)
- K070920FUJI IP CASSETTE TYPE PC2Cleared 510(K)
- K070305PRE-LOADED VISICOIL2Cleared 510(K)
- K070094TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM2Cleared 510(K)
- K063839POSITIONER2Cleared 510(K)
- K063270RPM RESPIRATORY GATING SYSTEM2Cleared 510(K)
- K063274ACCULOC BREAST LOCALIZATION SYSTEM2Cleared 510(K)
- K063021PROFILER 22Cleared 510(K)
- K062817PTW DAVID IMRT QC VERIFICATION SYSTEM2Cleared 510(K)
- K062618TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT2Cleared 510(K)
- K062611IGUIDE SYSTEM2Cleared 510(K)
- K060906CALYPSO 4D LOCALIZATION SYSTEM2Cleared 510(K)
- K061713MAGIS1;MAGIS22Cleared 510(K)
- K060895NOMOSSTAT, VERSION 1.02Cleared 510(K)
- K061140TRILOGY RADIOTHERAPY DELIVERY SYSTEM2Cleared 510(K)
- K060633COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.02Cleared 510(K)
- K060912MODIFICATION TO: HI-ART SYSTEM2Cleared 510(K)
- K060737SINMED POSITIONING DEVICES2Cleared 510(K)
- K060226ONCOR EXPRESSION2Cleared 510(K)
- K052212MIGUE2Cleared 510(K)
- K052705DART-122Cleared 510(K)
- K053500FRAMELESS RADIOSURGERY COMPONENTS2Cleared 510(K)
- K052920DELTA42Cleared 510(K)
- K052682ALIGNRT2Cleared 510(K)
- K052391VISION (WITH OFF-LINE REVIEW)2Cleared 510(K)
- K052220IPLAN RT FIBERTRACKING2Cleared 510(K)
- K051932ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.52Cleared 510(K)
- K051921THE EDGE DETECTOR, MODEL 11182Cleared 510(K)
- K042875NAVIGATOR2Cleared 510(K)
- K050888INTEGRA IMMOBILIZATION SYSTEM2Cleared 510(K)
- K043409ACCUCHANGER2Cleared 510(K)
- K050701THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-60102Cleared 510(K)
- K050372VISITRAK, VERSION 1, RELEASE 12Cleared 510(K)
- K0504794D INTEGRATED TREATMENT CONSOLE2Cleared 510(K)
- K050442MILLENNIUM MULTI-LEAF COLLIMATOR2Cleared 510(K)
- K042956VISION2Cleared 510(K)
- K042794BEAM MODULATOR, MODEL 4513 332 80002Cleared 510(K)
- K041937RESTITU2Cleared 510(K)
- K042720ON-BOARD IMAGER DEVICE2Cleared 510(K)
- K041519MODIFICATION TO: ON-BOARD IMAGER DEVICE2Cleared 510(K)
- K041557MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W2Cleared 510(K)
- K040687ONEDOSE PATIENT DOSIMETRY SYSTEM2Cleared 510(K)
- K041315CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY2Cleared 510(K)
- K040585EXACTRAC 4.0 AND EXACTRAC X-RAY 6D2Cleared 510(K)
- K040709PROTOS SOFTWARE2Cleared 510(K)
- K040773PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM2Cleared 510(K)
- K034051DYNATRAC, COD. 50-1A2Cleared 510(K)
- K040192ON-BOARD IMAGER DEVICE2Cleared 510(K)
- K033343TRILOGY RADIOTHERAPY DELIVERY SYSTEM2Cleared 510(K)
- K033287EXACTRAC GATING2Cleared 510(K)
- K032171ACCUSOFT2Cleared 510(K)
- K032762XIO RADIATION TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K033347MODIFICATION TO: HI-ART SYSTEM2Cleared 510(K)
- K032996ELEKTA SYNERGY SYSTEM2Cleared 510(K)
- K032725MOSFET AUTOSENSE WIRELESS2Cleared 510(K)
- K032100I-BEAM2Cleared 510(K)
- K032248PRECISE CARBON FIBER TABLE TOP, MODEL 11-9992Cleared 510(K)
- K032594ONE DIMENSIONAL WATER PHANTOM, WP 1D2Cleared 510(K)
- K031764ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES2Cleared 510(K)
- K032156ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT2Cleared 510(K)
- K031975IMSURE2Cleared 510(K)
- K031634OMNIPRO I'MRT2Cleared 510(K)
- K031631STEREOTACTIC BODY FRAME, MODEL COD. 70-1A2Cleared 510(K)
- K030439HEADFIX2Cleared 510(K)
- K0301752 BASIC2Cleared 510(K)
- K030051VERSABOARD, MODEL 70402Cleared 510(K)
- K024284VICTOREEN THEBES II, MODEL 70202Cleared 510(K)
- K023519RADIONICS VARILINK 22Cleared 510(K)
- K023449NON-INVASIVE PATIENT FIXATION SYSTEM2Cleared 510(K)
- K021338ACCULEAF2Cleared 510(K)
- K023293MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-022Cleared 510(K)
- K023636BLOCKING TRAY2Cleared 510(K)
- K022708KLARITY2Cleared 510(K)
- K020320RADIOSYSTEM/NT, MODEL 80-130202Cleared 510(K)
- K021124ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER2Cleared 510(K)
- K010065CRANIAL STEREOTACTIC EQUIPMENT2Cleared 510(K)
- K021463MODEL 1133 IVD PC VERSION2Cleared 510(K)
- K020860M3 (MICRO-MULTILEAF COLLIMATOR)2Cleared 510(K)
- K020294MOTION TRACKING2Cleared 510(K)
- K004022M3 (MIRCO-MULTILEAF COLLIMATOR2Cleared 510(K)
- K014081AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES2Cleared 510(K)
- K014022MRI LINE MARKER2Cleared 510(K)
- K013391BODYFIX2Cleared 510(K)
- K011845MILLCOMP2Cleared 510(K)
- K013279MOSFET AUTOSENSE, MODEL TN-RD-602Cleared 510(K)
- K012227MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.12Cleared 510(K)
- K004023INTRA OPERATIVE RADIATION THERAPY2Cleared 510(K)
- K011763OMNIDOS2Cleared 510(K)
- K012289MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)2Cleared 510(K)
- K011024CYBERKNIFE SYSTEM2Cleared 510(K)
- K003285EXAC TRAC 2.0 (NOVALIS BODY MODULE)2Cleared 510(K)
- K011332RF-IVD WIRELESS DOSIMETER-MODEL 11332Cleared 510(K)
- K003779IMMOBILIZATION SYSTEM FOR ENT2Cleared 510(K)
- K010916PTW DOSIMETRY DIODE, T600082Cleared 510(K)
- K003778BREAST-BOARD (MULTIPLE)2Cleared 510(K)
- K010464RADCALC, MODEL V.4.02Cleared 510(K)
- K010472PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-502Cleared 510(K)
- K010449IVD (IN VIVO DOSIMETER), MODEL 11312Cleared 510(K)
- K010975ECLIPSE 6.52Cleared 510(K)
- K010225DOSIMETRY CHECK2Cleared 510(K)
- K010174TRAY ADAPTERS, MULTIPLE2Cleared 510(K)
- K010063COUCH FOR TOTAL BODY RADIATION2Cleared 510(K)
- K010062STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM2Cleared 510(K)
- K004015BEAM BLOCK TRAYS2Cleared 510(K)
- K003636PORTALVISION2Cleared 510(K)
- K003330AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)2Cleared 510(K)
- K002608INVAC2Cleared 510(K)
- K000246RADIOCAMERAS EXTRACRANIAL SYSTEM2Cleared 510(K)
- K002444PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 2062Cleared 510(K)
- K001833PREFERENCE TREATMENT SYSTEM2Cleared 510(K)
- K002051INVIDOS2Cleared 510(K)
- K001052MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX2Cleared 510(K)
- K000209DOSE 12Cleared 510(K)
- K001643VARIS 1.4G2Cleared 510(K)
- K990209NOVAC72Cleared 510(K)
- K991133MLC FIT2Cleared 510(K)
- K994355RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION2Cleared 510(K)
- K993960PERMA-DOC PHANTOM2Cleared 510(K)
- K993959ISOCENTRIC BEAM CHECKER2Cleared 510(K)
- K992689MU PLUS2Cleared 510(K)
- K993742SUPER TISSUE2Cleared 510(K)
- K993359RAPTOR TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K993594CONFORMAX MMLC VR12Cleared 510(K)
- K993425PRIMUS2Cleared 510(K)
- K991319RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS2Cleared 510(K)
- K991966THE NOMOS CHANE II2Cleared 510(K)
- K991523TLC PEDIATRIC FRAME, MODEL TLC-SYS2Cleared 510(K)
- K991546AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD2Cleared 510(K)
- K991336BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY2Cleared 510(K)
- K991107SHADOW TRAYS2Cleared 510(K)
- K990997AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER2Cleared 510(K)
- K990833DOSE CALC, MODEL VS. 1.022Cleared 510(K)
- K990734DPD-12PCC2Cleared 510(K)
- K984241ROCS ULTRASEED2Cleared 510(K)
- K990383APOLLO 5, APOLLO 102Cleared 510(K)
- K981535FOCUS PILOT CONTOURING WORKSTATION2Cleared 510(K)
- K981153OSIRIS2Cleared 510(K)
- K990085MILLENNIUM MLC -1202Cleared 510(K)
- K982549RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC2Cleared 510(K)
- K981911PROFA2Cleared 510(K)
- K982713RT DESKTOP2Cleared 510(K)
- K982624MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-142422Cleared 510(K)
- K981597RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY2Cleared 510(K)
- K982463EXTRACRANIAL RADIOTHERAPY SYSTEM2Cleared 510(K)
- K981055XKNIFE-42Cleared 510(K)
- K981790IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW2Cleared 510(K)
- K982513MX MEVATRON2Cleared 510(K)
- K982502GENESIS IMRT LINEAR ACCELERATOR2Cleared 510(K)
- K981424NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM2Cleared 510(K)
- K981346RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM2Cleared 510(K)
- K981313SEQUENCER2Cleared 510(K)
- K980904MUCHECK MONITOR UNIT VALIDATION PROGRAM2Cleared 510(K)
- K980826EQUIDOSE SOLID STATE DIODE DETECTORS2Cleared 510(K)
- K973936FOCUS RTP SYSTEM2Cleared 510(K)
- K980750RADIOCAMERAS PATIENT POSITIONING SYSTEM2Cleared 510(K)
- K980379PROWESS PRO-SIM2Cleared 510(K)
- K980629VSS, VIRTUAL SIMULATION SYSTEM2Cleared 510(K)
- K980402CAPINTEC MODEL 292 ELECTROMETER2Cleared 510(K)
- K974703CARBON FIBER BREAST BOARD2Cleared 510(K)
- K974700MATRIX MT-MX32Cleared 510(K)
- K974310NOMOS SLIT COLLIMATOR (BEAK)2Cleared 510(K)
- K972816ADVANCED TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K972451COREGISTRATION FUNCTION2Cleared 510(K)
- K973963120 LEAF MULTILEAF COLLIMATOR2Cleared 510(K)
- K973540ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS2Cleared 510(K)
- K973889VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE2Cleared 510(K)
- K971893SNT LINAC ACCESSORIES2Cleared 510(K)
- K972905XPLAN-12Cleared 510(K)
- K971367BRAINSCAN CONFORMAL RT MODULE2Cleared 510(K)
- K972804BANG POLYMER GEL DOSIMETER, BANG 5332Cleared 510(K)
- K972709TBI STAND2Cleared 510(K)
- K972617HELAX-VISIR2Cleared 510(K)
- K972275LANTIS TREATSTATION2Cleared 510(K)
- K970464P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.12Cleared 510(K)
- K963451ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING2Cleared 510(K)
- K970384VELOS CONSTANCY CHECK DEVICE, MODEL 55-1452Cleared 510(K)
- K965010TARGET 2 VERSION 1.12Cleared 510(K)
- K962950CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K970236THERAPLAN PLUS VERSION 1.22Cleared 510(K)
- K964206NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V22Cleared 510(K)
- K964785VERIDOSE DIODES2Cleared 510(K)
- K971382PRONE BREAST POSITIONING BOARD, MODEL #37-0182Cleared 510(K)
- K970586BRAINLAB MICRO MULTI-LEAF COLLIMATOR2Cleared 510(K)
- K970564DYNAMIC WEDGE2Cleared 510(K)
- K970291ACCESSORIES TO THE STEREOTACTIC BODY FRAM2Cleared 510(K)
- K970137EXL-12SP,12DP,15DP,20DP LINAC2Cleared 510(K)
- K964517LINAC SCALPEL FLOORSTAND2Cleared 510(K)
- K964167DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)2Cleared 510(K)
- K964840BEAM BLOCK TRAYS2Cleared 510(K)
- K962335MLC FIT2Cleared 510(K)
- K964485PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM2Cleared 510(K)
- K961400RFA-300, LDA UTILITY2Cleared 510(K)
- K963860THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM2Cleared 510(K)
- K963624PHILIPS SLI SERIES LINEAR ACCELERATOR2Cleared 510(K)
- K963258PEACOCK SYSTEM2Cleared 510(K)
- K962792LINAC SCALPEL TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K954679THERAPLAN PLUS2Cleared 510(K)
- K961484CASS SYSTEM (MODIFICATION)2Cleared 510(K)
- K962487BREAST TREATMENT AID M2002Cleared 510(K)
- K962080RPS-50 BEAM SCANNER2Cleared 510(K)
- K962155GILL-THOMAS-COSMAN(GTC) DENTAL TRAY2Cleared 510(K)
- K961467HEAD RETAINING DEVICE2Cleared 510(K)
- K961214MULTI LEAF COLLIMATOR2Cleared 510(K)
- K954861BRAINLAB CT/X-RAY LOCALIZER2Cleared 510(K)
- K960293MRTOFLM COMPUTER PROGRAM2Cleared 510(K)
- K961170BREAST TREATMENT AID2Cleared 510(K)
- K9612080.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER2Cleared 510(K)
- K960834KODAK EC-L CASSETTE2Cleared 510(K)
- K960338STEREOTACTIC BODY FRAME2Cleared 510(K)
- K960510THERAVIEW2Cleared 510(K)
- K954564PID-1 PRECISION INTELLIGENT DOSIMETER2Cleared 510(K)
- K940663PEACOCK PLAN2Cleared 510(K)
- K951581PINNACLE3 APEX2Cleared 510(K)
- K955774VARIS PORTALVISION2Cleared 510(K)
- K953508COMPUTE-RX PLAN PC3D2Cleared 510(K)
- K943224VARIAN MULTILEAF COLLIMATOR2Cleared 510(K)
- K952314EXL-12SP & 12DP LINAC2Cleared 510(K)
- K954705ACRYSTEEL BLOCKING TRAY2Cleared 510(K)
- K954634RADIOSURGERY VERIFICATION PHANTOM2Cleared 510(K)
- K952108EXL-15DP & 20-DP LINAC2Cleared 510(K)
- K946074ALDERSON BREST DOSIMETRY SYSTEM2Cleared 510(K)
- K954165PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM2Cleared 510(K)
- K940001PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)2Cleared 510(K)
- K953570PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP)2Cleared 510(K)
- K953482XKNIFE-32Cleared 510(K)
- K951764UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR2Cleared 510(K)
- K953046PERI-PUSHER2Cleared 510(K)
- K952729PAINTED WEDGE & ROD BREAST BOARD2Cleared 510(K)
- K941118HEAD IMMOBILIZATION APPARATUS2Cleared 510(K)
- K952457RAPID-FOAM2Cleared 510(K)
- K950061HERCULES RADIATION THERAPY COUCH2Cleared 510(K)
- K952189MED-TEC REDISET2Cleared 510(K)
- K944040PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM2Cleared 510(K)
- K950075MED-TEC TRAY ADAPTER2Cleared 510(K)
- K951947MED-TEC RADIO THERAPY TREATMENT CHAIR2Cleared 510(K)
- K951679MED-TEC TESTICULAR SEPARATOR2Cleared 510(K)
- K945321WELLHOFER WP700 V. 3.22Cleared 510(K)
- K951808MED-TEC REDI-FOAM2Cleared 510(K)
- K951717MED-TEC KNEE CRUTCH2Cleared 510(K)
- K951143PULSE KLYSTRON AMPLIFIFER (L-5822-90)2Cleared 510(K)
- K951142PULSE KLYSTRON AMPLIFIER (L-5822-00)2Cleared 510(K)
- K935615MEDICAL LINEAR ACCELERATOR2Cleared 510(K)
- K945903BRAINLAB MASK SYSTEM2Cleared 510(K)
- K950866HIP FIXATION SYSTEM2Cleared 510(K)
- K942346IMAGERT2Cleared 510(K)
- K943714MICRO MULTILEAF COLLIMATOR2Cleared 510(K)
- K926449VARIAN MULTILEAF COLLIMATOR, RELEASE 4.02Cleared 510(K)
- K933117IORT SYSTEM2Cleared 510(K)
- K934523GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1)2Cleared 510(K)
- K943464PHILIPS IMPROVED CHECK RADIOGRAPH OPTION2Cleared 510(K)
- K940145COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE2Cleared 510(K)
- K943406RF DRIVER, RADIO FREQUENCY DRIVER2Cleared 510(K)
- K940660MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM2Cleared 510(K)
- K943199MOTORIZED DEPTH DOSE APPARATUS2Cleared 510(K)
- K944315BLOCKING TRAY2Cleared 510(K)
- K926008PINNACLE 32Cleared 510(K)
- K932501VARIAN ORIGAMI, VERSION 1.02Cleared 510(K)
- K930513VARIAN RMS-2000, RELEASE 2.52Cleared 510(K)
- K924685STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM2Cleared 510(K)
- K942083ADVANCED THERAPY DOSIMETER2Cleared 510(K)
- K930506THERPAC RADIOTHERAPY TREATMENT PLANNING SYSTEM2Cleared 510(K)
- K934303RFA A-3002Cleared 510(K)
- K926321VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D)2Cleared 510(K)
- K942092DPD-32Cleared 510(K)
- K935928RIT 113 FILM ANALYSIS SYSTEM2Cleared 510(K)
- K935435NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST2Cleared 510(K)
- K940237THERAPLAN V05B/ TP-11 V09B2Cleared 510(K)
- K934657BRAINLAB LINAC HARDWARE2Cleared 510(K)
- K942282MED-TEC BREAST SUPPORT SYSTEM2Cleared 510(K)
- K935412MED-TEC, INC. BREAST BOARD, MT-2002Cleared 510(K)
- K935411MED-TEC, INC. BREAST BOARD, MT-2502Cleared 510(K)
- K935300VAC-LOK IMMOBILIZATION SYSTEM2Cleared 510(K)
- K933227UNI-FRAME HEAD IMMOBILIZATION SYSTEM2Cleared 510(K)
- K932598TN-RD-502Cleared 510(K)
- K935067AQUAPLAST2Cleared 510(K)
- K922276THERAC 252Cleared 510(K)
- K926187POSICAST IMMOBILIZATION SYSTEM2Cleared 510(K)
- K935021HANDI-FOAM2Cleared 510(K)
- K933558ARM RADIATION BEAM SCANNER2Cleared 510(K)
- K930182RADIATION TREATMENT FOR CANCER PATIENTS2Cleared 510(K)
- K931927VICTOREEN MODEL 5302Cleared 510(K)
- K934566RADASSIST2Cleared 510(K)
- K933493RAM-PACS2Cleared 510(K)
- K9336133-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER2Cleared 510(K)
- K933614PITUITARY BOARD2Cleared 510(K)
- K923522LINAC-BASED STEROTACTIC RADIOSURGERY2Cleared 510(K)
- K930279REFIX(TM) SYSTEM2Cleared 510(K)
- K930246MAMMORX2Cleared 510(K)
- K925714BREAST SIMULATION SYSTEM2Cleared 510(K)
- K924495PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM2Cleared 510(K)
- K924240PROWESS 20002Cleared 510(K)
- K924632LCM-2-LINAC COUCH-MOUNT SYSTEM2Cleared 510(K)
- K921740COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED2Cleared 510(K)
- K920879BRAINSCAN RADIOSURGERY MODULE2Cleared 510(K)
- K921991PLATO RADIATION THERAPY PLANNING SYSTEM2Cleared 510(K)
- K911973LINEAR ACCELERATOR COLLIMATOR2Cleared 510(K)
- K914698SETUP COMPUTER WITH SOFTWARE V-1261,62 AND 632Cleared 510(K)
- K920455THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.)2Cleared 510(K)
- K920041ADAC XL-PLAN-PC2Cleared 510(K)
- K913612SEQUENCER2Cleared 510(K)
- K913674RECORD AND VERIFY MEVATRON ADAPTER2Cleared 510(K)
- K913119VARIAN C-SERIES CLINACS (CLINAC 2300C/D)2Cleared 510(K)
- K913174VARIAN CLINAC 600SR2Cleared 510(K)
- K912630XKNIFE RADIOSURGERY SYSTEM2Cleared 510(K)
- K911750COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED2Cleared 510(K)
- K911612NUCLETRON PLANNING SYSTEM2Cleared 510(K)
- K904908STEREOTACTIC IRRADIATION SYSTEM2Cleared 510(K)
- K901932VARIAN ELECTRONIC PORTAL IMAGING SYSTEM2Cleared 510(K)
- K904364VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C2Cleared 510(K)
- K905007STANDARD BREAST BOARDS; DELUXE BREAST BOARD2Cleared 510(K)
- K903139BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)2Cleared 510(K)
- K900434MM-22 MICROTRON, MM50 MICROTRON2Cleared 510(K)
- K902339THERAVIEW DIGITAL PORTAL IMAGING COMPUTER2Cleared 510(K)
- K902849PHILIPS VERIFLEX2Cleared 510(K)
- K892425STP COMPLETE MODULE SET2Cleared 510(K)
- K895697VAC FIX(R) SYSTEM2Cleared 510(K)
- K894722RENNER-PLAN2Cleared 510(K)
- K895733FIBERVISION(TM)2Cleared 510(K)
- K895500PATIENT POSITIONING ACCESSORIES2Cleared 510(K)
- K894912SRI 100 RADIOTHERAPY IMAGING SYSTEM2Cleared 510(K)
- K894706HT-RES RTP SYSTEM2Cleared 510(K)
- K891292SRS-200 RADIOSURGERY SYSTEM2Cleared 510(K)
- K893978MEDISYS RECORD AND VERIFY SYSTEM2Cleared 510(K)
- K894230PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735)2Cleared 510(K)
- K894123VERICORD S32Cleared 510(K)
- K892845SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE2Cleared 510(K)
- K892860SATURNE 412Cleared 510(K)
- K883019SATURNE 42 AND 432Cleared 510(K)
- K883264SL SERIES ACCELERATORS SL15, SL18, SL20 & SL252Cleared 510(K)
- K883101DVS (OPTION 01)2Cleared 510(K)
- K883067MODIFIED SL-SERIES LINEAR ACCELERATORS2Cleared 510(K)
- K882231SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)2Cleared 510(K)
- K882729MEVATRON, M 2 CLASS2Cleared 510(K)
- K882326VARIAN CLINAC 1800S2Cleared 510(K)
- K880200EXL-14 MEDICAL LINEAR ACCELERATOR2Cleared 510(K)
- K874558SL SERIES, SL 15, 18, 20 & 252Cleared 510(K)
- K873398EXL-22DP X-RAY RADIATION THERAPY SYSTEM2Cleared 510(K)
- K874893MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR2Cleared 510(K)
- K871214GRATICULE2Cleared 510(K)
- K870525PHILIPS MODEL SL75-10 LINEAR ACCELERATOR2Cleared 510(K)
- K864910MEVACHECK2Cleared 510(K)
- K863705COMPUTER CONTROLLED EXTENSION (CCX)2Cleared 510(K)
- K862339MEVATRON KD-22Cleared 510(K)
- K862645CLINAC (R) C SERIES (400C, 600C, 2100C, 2500C)2Cleared 510(K)
- K863358VARIAN RMS-20002Cleared 510(K)
- K862065PC-PLAN2Cleared 510(K)
- K852609MEVASSIST(SETUP CONTROLLER)2Cleared 510(K)
- K851041ADAC MODELS XL-PLAN 23 & XL-PLAN 732Cleared 510(K)
- K840136LINEAR ACCELERATOR MULTIPLE EXL 3-4-62Cleared 510(K)
- K833941ORION2Cleared 510(K)
- K832732RADIOTHERAPY MGMT. SYSTEM RMS-10002Cleared 510(K)
- K832502ELECTRON BEAM OPTION FOR CLINAC 15 MEV2Cleared 510(K)
- K832503CLINAC 18002Cleared 510(K)
- K832216VARIAN CLINACOMP 100 TISSUE COMPENSATOR2Cleared 510(K)
- K837347LINEAR ACCELERATOR THERAC 252Cleared 510(K)
- K820448ARS-10002Cleared 510(K)
- K820310DELTA PLAN II RADIATION THERAPY PLAN2Cleared 510(K)
- K812032MEVATRON 67E2Cleared 510(K)
- K8028086MV PORT FILM CAPABILITY OPTION2Cleared 510(K)
- K802809ELECTRON ARC THERAPY2Cleared 510(K)
- K800791MYLAR WINDOW-TABLE INSERT PANEL2Cleared 510(K)
- K800790TENNIS RACKET-TABLE INSERT PANEL2Cleared 510(K)
- K800792ADJUSTABLE HEAD & FACE HOLDER2Cleared 510(K)
- K800761POINT TO POINT LEVEL2Cleared 510(K)
- K800759ELEV. BACK SUPPORT W/ADJ. ARM POSITIONER2Cleared 510(K)
- K791967MEVATRON 74X MEDICAL LINEAR ACCELERATOR2Cleared 510(K)
- K790747MEVATRON 742Cleared 510(K)
- K790688MEVATRON 672Cleared 510(K)
- K790388MEVATRON 602Cleared 510(K)
- K781872CLINAC 25002Cleared 510(K)
- K781174CLINAC 12/102Cleared 510(K)
- K781057CLINAC 20 (OPTIONAL 18 MV VERSION)2Cleared 510(K)
- K780027ACCELERATOR, LINEAR, MED.2Cleared 510(K)
- K771902EMI FOUR2Cleared 510(K)
- K771808CLINAC 4/1002Cleared 510(K)
- K771809CLINAC 6/1002Cleared 510(K)
- K771358CLINAC 202Cleared 510(K)
- K771260LINEAR ACCELERATOR G-29002Cleared 510(K)
- 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
Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
- Page Type
- Cleared 510(K)
- 510(k) Number
- K210500
- 510(k) Type
- Traditional
- Applicant
- Elekta Limited
- Country
- United Kingdom
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/11/2021
- Days to Decision
- 109 days
- Submission Type
- Summary