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
- K231612Eve Patient Positioner System2Cleared 510(K)
- K182683Z-Robot Patient Positioning System2Cleared 510(K)
- K170502Patient Positioning System2Cleared 510(K)
- K160518LEONI ORION System2Cleared 510(K)
- K132084PROTURA COUCH SOFTWARE2Cleared 510(K)
- K122413PATIENT POSITIONING SYSTEM2Cleared 510(K)
- K122201PROTURA COUCH SOFTWARE2Cleared 510(K)
- K120520EXACTRAC ROBOTICS NOVALIS ROBOTICS2Cleared 510(K)
- K120916QFIX RADIOTHERAPY CHAIR2Cleared 510(K)
- K072898HEXAPOD EVO RT COUCH TOP2Cleared 510(K)
- K071870HEXAPOD RT COUCH TOP2Cleared 510(K)
- K062639MODIFICATION TO HEXAPOD RT COUCH TOP2Cleared 510(K)
- K060870AVANZA2Cleared 510(K)
- K060671KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS2Cleared 510(K)
- K050422550 TXT TREATMENT TABLE2Cleared 510(K)
- K042146ROBOCOUCH PATIENT SUPPORT SYSTEM2Cleared 510(K)
- K041448HEXAPOD RT COUCHTOP2Cleared 510(K)
- K033316TABLE TILT DEVICE2Cleared 510(K)
- K034054PRO SERIES COUCH SOFTWARE, MODEL MT-PRO1002Cleared 510(K)
- K031866MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC2Cleared 510(K)
- K013036NOMOS MOTORIZED CRANE II2Cleared 510(K)
- K993522AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT2Cleared 510(K)
- K983678ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE2Cleared 510(K)
- K982446DYNAMIC SHIELDING RADIATION TABLE2Cleared 510(K)
- K964740THE NOMOS MINICRANE2Cleared 510(K)
- K941927THE NOMOS CRANE2Cleared 510(K)
- K910648THERAPY CHAIR SYSTEM2Cleared 510(K)
- K910002GENESYS AND THE ROI2Cleared 510(K)
- K910971Z XT RADIATION THERAPY TREATMENT TABLE2Cleared 510(K)
- K855063UNIVERSAL PATIENT CHAIR UNI 2000X2Cleared 510(K)
- K834201TCT-1 TREATMENT COUCH2Cleared 510(K)
- K837152THERAC 25 LINEAR ACCELERATOR2Cleared 510(K)
- 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
GENESYS AND THE ROI
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K910002
- 510(k) Type
- Traditional
- Applicant
- THE COMPLETE SYSTEMS CORP. GENESYS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/22/1991
- Days to Decision
- 201 days