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
- K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)2Cleared 510(K)
- K232854Leksell GammaPlan (LGP)2Cleared 510(K)
- K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)2Cleared 510(K)
- K203250TaiChiC2Cleared 510(K)
- K203146Akesis Galaxy RTi2Cleared 510(K)
- K200050Akesis Galaxy RTx2Cleared 510(K)
- K190844Akesis Galaxy2Cleared 510(K)
- K180571GammaPod2Cleared 510(K)
- K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon2Cleared 510(K)
- K173791Leksell GammaPlan2Cleared 510(K)
- K172706GammaPod - Model A2Cleared 510(K)
- K160440Leksell Gamma Knife Icon2Cleared 510(K)
- K151159Leksell Gamma Knife Perfexion2Cleared 510(K)
- K151561Leksell Gamma Knife Icon2Cleared 510(K)
- K150191GammaBeam 5002Cleared 510(K)
- K142219GammaBeam 1002Cleared 510(K)
- K133565LEKSELL GAMMA KNIFE PERFEXION2Cleared 510(K)
- K131777HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM2Cleared 510(K)
- K120811LEKSELL GAMMA KNIFE PERFEXION2Cleared 510(K)
- K102533ROTATING GAMMA SYSTEM INFINI (INFINI)2Cleared 510(K)
- K092083EXTEND FRAME SYSTEM, MODEL 10096332Cleared 510(K)
- K063512LEKSELL GAMMA KNIFE PERFEXION2Cleared 510(K)
- K061941LEKSELL GAMMA KNIFE PERFEXION, MODEL 7150002Cleared 510(K)
- K061540LEKSELL GAMMAPLAN2Cleared 510(K)
- K060314ROTATING GAMMA SYSTEM. GAMMA ART-60002Cleared 510(K)
- K053485THERATRON EQUINOX, MODELS 80 CM AND 100 CM2Cleared 510(K)
- K051022GAMMAPLAN2Cleared 510(K)
- K041125MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)2Cleared 510(K)
- K001006THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE2Cleared 510(K)
- K000478THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.12Cleared 510(K)
- K984563THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY2Cleared 510(K)
- K984328LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 240012Cleared 510(K)
- K983917THERATRON ELITE2Cleared 510(K)
- K973441LEKSELL GAMMAPLAN2Cleared 510(K)
- K964606THERATRON 780E2Cleared 510(K)
- K970647OUR ROTATING GAMMA SYSTEM2Cleared 510(K)
- K960892THE COBALT SCALPEL2Cleared 510(K)
- K924849LEKSELL GAMMA UNIT MODEL 23004,TYPE B.2Cleared 510(K)
- K925133DPD-510 THERAPEUTIC RADIATION DOSIMETER2Cleared 510(K)
- K914808LEKSELL GAMMAPLAN (LGP)2Cleared 510(K)
- K912250ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES2Cleared 510(K)
- K894165THERATRON 10002Cleared 510(K)
- K871215DISPOSABLE SHADOW TRAY INSERTS2Cleared 510(K)
- K863180THERATRON-PHOENIX2Cleared 510(K)
- K860849MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM2Cleared 510(K)
- K850543THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY2Cleared 510(K)
- K827583STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE2Cleared 510(K)
- K780948SYSTEM, PLANNING, TREATMENT2Cleared 510(K)
- 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
- 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
Leksell Gamma Knife Icon
- Page Type
- Cleared 510(K)
- 510(k) Number
- K151561
- 510(k) Type
- Traditional
- Applicant
- ELEKTA INSTRUMENT AB
- Country
- Sweden
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/4/2015
- Days to Decision
- 55 days
- Submission Type
- Summary