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
- 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)
- K161144iDMS Data Management System2Cleared 510(K)
- K161146Radixact Treatment Delivery 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)
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- K060633COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.02Cleared 510(K)
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- K053500FRAMELESS RADIOSURGERY COMPONENTS2Cleared 510(K)
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- K052391VISION (WITH OFF-LINE REVIEW)2Cleared 510(K)
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- K051932ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.52Cleared 510(K)
- K051921THE EDGE DETECTOR, MODEL 11182Cleared 510(K)
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- K031975IMSURE2Cleared 510(K)
- K031634OMNIPRO I'MRT2Cleared 510(K)
- K031631STEREOTACTIC BODY FRAME, MODEL COD. 70-1A2Cleared 510(K)
- K030439HEADFIX2Cleared 510(K)
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- K004023INTRA OPERATIVE RADIATION THERAPY2Cleared 510(K)
- K011763OMNIDOS2Cleared 510(K)
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- K002444PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 2062Cleared 510(K)
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- K981346RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM2Cleared 510(K)
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- K921740COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED2Cleared 510(K)
- K920879BRAINSCAN RADIOSURGERY MODULE2Cleared 510(K)
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- 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)
- K800759ELEV. BACK SUPPORT W/ADJ. ARM POSITIONER2Cleared 510(K)
- K800761POINT TO POINT LEVEL2Cleared 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)
- K771809CLINAC 6/1002Cleared 510(K)
- K771808CLINAC 4/1002Cleared 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
RefleXion Medical Radiotherapy System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K190978
- 510(k) Type
- Traditional
- Applicant
- RefleXion Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/12/2020
- Days to Decision
- 332 days
- Submission Type
- Summary