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
- K242418P-Cure Proton Therapy System (PPTS)2Cleared 510(K)
- K232032PROBEAT-FR2Cleared 510(K)
- K231863ProBeam 360° Proton Therapy System v2.0 (Multiroom)2Cleared 510(K)
- K221996P-Cure Proton Beam Therapy System2Cleared 510(K)
- K220883Small Field Applicator2Cleared 510(K)
- K221791ProBeam 360° Proton Therapy System2Cleared 510(K)
- K201798myQA iON2Cleared 510(K)
- K201042PROBEAT-CR2Cleared 510(K)
- K200282Orfit Aerial Couchtop2Cleared 510(K)
- K191821Blue Phantom PT2Cleared 510(K)
- K191521Radiance 330 Proton Beam Therapy System2Cleared 510(K)
- K191801PROBEAT-CR2Cleared 510(K)
- K181498X-ray Imaging System for the McLaren Proton Treatment System2Cleared 510(K)
- K181789VeriSuite2Cleared 510(K)
- K181676Mini Ridge Filter and auxiliary functions for PROBEAT-V2Cleared 510(K)
- K172848MEVION S250i Proton Beam Radiation Therapy Device2Cleared 510(K)
- K171049Real Time Image Gating System for Proton Beam Therapy Systems2Cleared 510(K)
- K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)2Cleared 510(K)
- K170719Anzai Respiratory Gating System2Cleared 510(K)
- K162246ProNova SC360 Proton Therapy System2Cleared 510(K)
- K160612Sumitomo Proton Therapy System2Cleared 510(K)
- K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)2Cleared 510(K)
- K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory2Cleared 510(K)
- K160432Anzai Respiratory Gating System2Cleared 510(K)
- K153614PROBEAT-V and accessories2Cleared 510(K)
- K160063McLaren Proton Therapy System2Cleared 510(K)
- K152592PROBEAT-V2Cleared 510(K)
- K152207Extended Range Shifter for PROBEAT-V2Cleared 510(K)
- K151132PROBEAT-V2Cleared 510(K)
- K132919GANTRY BEAM LINE2Cleared 510(K)
- K133914VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE2Cleared 510(K)
- K134052RADIANCE 330 PROTON THERAPY SYSTEM2Cleared 510(K)
- K133191PROBEAM PROTON THERAPY SYSTEM2Cleared 510(K)
- K132847I2C2Cleared 510(K)
- K130426SUMITOMO PROTON THERAPY SYSTEM2Cleared 510(K)
- K124002VERIFICATION CONSOLE2Cleared 510(K)
- K120676S-250 PROTON BEAM RADIATION THERAPY SYSTEM2Cleared 510(K)
- K112969AIR-BAG SYSTEM2Cleared 510(K)
- K112981SUN 125C IONIZATION CHAMBER2Cleared 510(K)
- K112768CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING2Cleared 510(K)
- K101294PT2 VARIAN PROTON THERAPY SYSTEM2Cleared 510(K)
- K102373CALYPSO SYSTEM WITH DYNAMIC EDGE GATING2Cleared 510(K)
- K101508MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 2352Cleared 510(K)
- K100766IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 2352Cleared 510(K)
- K093250PROTON THERAPY MULTILEAF COLLIMATOR2Cleared 510(K)
- K092796IBA PROTON THERAPY SYSTEM, PROTEUS 2352Cleared 510(K)
- K092653VERISUITE AND VERISUITE-PARTICLE, VERSION 1.82Cleared 510(K)
- K091629PROTEUS 235 PROTON THERAPY SYSTEM2Cleared 510(K)
- K083058IBA PROTON THERAPY SYSTEM - PROTEUS 2352Cleared 510(K)
- K082416IBA PROTON THERAPY SYSTEM- PROTEUS 2352Cleared 510(K)
- K080799ATLAS-BASED AUTOSEGMENTATION2Cleared 510(K)
- K080886IPLAN RT IMAGE2Cleared 510(K)
- K073059PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM2Cleared 510(K)
- K071399DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-1002Cleared 510(K)
- K062891PROTON THERAPY SYSTEM2Cleared 510(K)
- K061913IBA PROTON THERAPY SYSTEM - PROTEUS 2352Cleared 510(K)
- K061051DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER2Cleared 510(K)
- K061152MUCHECK V7.02Cleared 510(K)
- K060834PROBEAT WITH MGCS2Cleared 510(K)
- K060695IBA PROTON THERAPY SYSTEM - PROTEUS 2352Cleared 510(K)
- K052118DOSE VERIFICATION SYSTEM2Cleared 510(K)
- K053280PROBEAT2Cleared 510(K)
- K053641IBA PROTON THERAPY SYSTEM-PROTEUS 2352Cleared 510(K)
- K032511INTUITION IMAGE2Cleared 510(K)
- K032886DIAMOND SETUP 20002Cleared 510(K)
- K031385ANZAI AZ-733 RESPIRATORY GATING SYSTEM2Cleared 510(K)
- K983332NORTHEAST PROTON THERAPY CENTER2Cleared 510(K)
- K983024PROTON THERAPY SYSTEM2Cleared 510(K)
- K002194TREATVISION2Cleared 510(K)
- K992414PROTON BEAM THERAPY SYSTEM (PBTS)2Cleared 510(K)
- K983660EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)2Cleared 510(K)
- K983629RPM RESPIRATORY GATING SYSTEM2Cleared 510(K)
- K982952IMFAST2Cleared 510(K)
- K983342MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE2Cleared 510(K)
- K982937MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER2Cleared 510(K)
- K981112MOBETRON2Cleared 510(K)
- K981358ARTOSCAN S2Cleared 510(K)
- K981115RADIO-PLAST2Cleared 510(K)
- K973960MODEL 37-1852Cleared 510(K)
- K9722120.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER2Cleared 510(K)
- K972211MULTIDOS, QC6PLUS2Cleared 510(K)
- K953391TREATMENT MANAGEMENT SYSTEM2Cleared 510(K)
- K891261INTRAOPERATIVE RADIATION THERAPY DEVICES2Cleared 510(K)
- K860606RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM2Cleared 510(K)
- K853964COMPUTERIZED RADIATION TREATMENT PLANNING SYS2Cleared 510(K)
- K851301TARGET CAT#B7850AA & B7850AB & B7850B2Cleared 510(K)
- K852907SIEMENS MEVATRON ME2Cleared 510(K)
- 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
PROBEAT-CR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K191801
- 510(k) Type
- Traditional
- Applicant
- Hitachi Ltd.
- Country
- Japan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/13/2019
- Days to Decision
- 72 days
- Submission Type
- Summary