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
- EAGCephalometer2Product Code
- EAHCone, Radiographic, Lead-Lined1Product Code
- EAPUnit, X-Ray, Intraoral2Product Code
- EHBCollimator, X-Ray1Product Code
- EHDUnit, X-Ray, Extraoral With Timer2Product Code
- MUHSystem, X-Ray, Extraoral Source, Digital2Product Code
- EAMScreen, Intensifying, Radiographic1Product Code
- EGTController, Temperature, Radiographic2Product Code
- EGWDryer, Film, Radiographic2Product Code
- EGYProcessor, Radiographic-Film, Automatic, Dental2Product Code
- HBKChair, Pneumoencephalographic2Product Code
- ITXTransducer, Ultrasonic, Diagnostic2Product Code
- ITYAssembly, Tube Housing, X-Ray, Diagnostic1Product Code
- IWNCassette, Measurement, Ardran-Crooks1Product Code
- IWYHolder, Head, Radiographic1Product Code
- IWZFilm, Radiographic1Product Code
- IXACassette, Radiographic Film2Product Code
- IXCIlluminator, Radiographic-Film1Product Code
- IXDSource, Calibration, Sealed, Nuclear1Product Code
- IXFTest-Pattern, Radiographic1Product Code
- IXGPhantom, Anthropomorphic, Radiographic1Product Code
- IXHCamera, Focal Spot, Radiographic1Product Code
- IXJGrid, Radiographic1Product Code
- IXKSystem, Imaging, X-Ray, Electrostatic2Product Code
- IXLDevice, Spot-Film2Product Code
- IXOSynchronizer, Ecg / Respirator, Radiographic1Product Code
- IXQTable, Radiographic, Stationary Top2Product Code
- IXRTable, Radiographic, Tilting2Product Code
- IXWProcessor, Radiographic-Film, Automatic2Product Code
- IXXProcessor, Cine Film2Product Code
- IXYHolder, Radiographic Cassette, Wall-Mounted1Product Code
- IYBTube Mount, X-Ray, Diagnostic1Product Code
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic2Product Code
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic2Product Code
- IYPPhantom, Anthropomorphic, Nuclear1Product Code
- IYQPhantom, Flood Source, Nuclear1Product Code
- IYTSystem, Rebreathing, Radionuclide2Product Code
- IYWScanner, Rectilinear, Nuclear1Product Code
- IYXCamera, Scintillation (Gamma)1Product Code
- IYYSynchronizer, Electrocardiograph, Nuclear1Product Code
- IYZBed, Scanning, Nuclear1Product Code
- IZCCamera, Positron1Product Code
- IZDProbe, Uptake, Nuclear1Product Code
- IZFSystem, X-Ray, Tomographic2Product Code
- IZGSystem, X-Ray, Photofluorographic2Product Code
- IZHSystem, X-Ray, Mammographic2Product Code
- IZISystem, X-Ray, Angiographic2Product Code
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot2Product Code
- IZLSystem, X-Ray, Mobile2Product Code
- IZOGenerator, High-Voltage, X-Ray, Diagnostic1Product Code
- IZPProgrammer, Changer, Film/Cassette, Radiographic2Product Code
- IZSAperture, Radiographic2Product Code
- IZTCone, Radiographic2Product Code
- IZWCollimator, Automatic, Radiographic2Product Code
- IZXCollimator, Manual, Radiographic2Product Code
- IZZTable, Radiographic, Non-Tilting, Powered2Product Code
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified2Product Code
- JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified2Product Code
- JACSystem, X-Ray, Film Marking, Radiographic1Product Code
- JAFMonitor, Ultrasonic, Nonfetal2Product Code
- JAGIlluminator, Radiographic-Film, Explosion-Proof1Product Code
- JAKSystem, X-Ray, Tomography, Computed2Product Code
- JAMScanner, Whole Body, Nuclear1Product Code
- JANCounter, Whole Body, Nuclear1Product Code
- JAOScanner, Fluorescent2Product Code
- JARPhantom, Test-Pattern, Radionuclide1Product Code
- JWMSystem, Tomographic, Nuclear2Product Code
- KGIDensitometer, Bone2Product Code
- KPRSystem, X-Ray, Stationary2Product Code
- KPSSystem, Tomography, Computed, Emission2Product Code
- KPTCalibrator, Dose, Radionuclide2Product Code
- KPWDevice, Beam Limiting, X-Ray, Diagnostic2Product Code
- KPXChanger, Radiographic Film/Cassette2Product Code
- KXHCradle, Patient, Radiologic1Product Code
- KXJTable, Radiologic2Product Code
- LEKTransilluminator (Diaphanoscope)3Product Code
- LHOInstrument, Quality-Assurance, Radiologic1Product Code
- LLZSystem, Image Processing, Radiological2Product Code
- LMADigitizer, Image, Radiological2Product Code
- LMBDevice, Digital Image Storage, Radiological1Product Code
- LMCCamera, Multi Format, Radiological2Product Code
- LMDSystem, Digital Image Communications, Radiological1Product Code
- LNHSystem, Nuclear Magnetic Resonance Imaging2Product Code
- LNISystem, Nuclear Magnetic Resonance Spectroscopic2Product Code
- LQAMedia, Reusable Image1Product Code
- MOSCoil, Magnetic Resonance, Specialty2Product Code
- MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2Product Code
- MUABone Sonometer2Product Code
- MUEFull Field Digital, System, X-Ray, Mammographic2Product Code
- MUIMedia, Coupling, Ultrasound2Product Code
- MWPCabinet, X-Ray System2Product Code
- MYNAnalyzer, Medical Image2Product Code
- NCSSystem, Imaging, Holography, Acoustic2Product Code
- NWEColon Computed Tomography System, Computer Aided Detection2Product Code
- OASX-Ray, Tomography, Computed, Dental2Product Code
- OEBLung Computed Tomography System, Computer-Aided Detection2Product Code
- OIIArthrogram Tray2Product Code
- OIJBiopsy Needle Guide Kit2Product Code
- OIKRadiology Dental Tray2Product Code
- OILDiscography Kit2Product Code
- OIMMri Disposable Kit2Product Code
- OIORadiographic Contrast Tray2Product Code
- OIPRadiology-Diagnostic Kit2Product Code
- OMJChest X-Ray Computer Aided Detection2Product Code
- OQQDiagnostic Ultrasonic Transducer, Robotic2Product Code
- OUOTomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance2Product Code
- OWBInterventional Fluoroscopic X-Ray System2Product Code
- OXOImage-Intensified Fluoroscopic X-Ray System, Mobile2Product Code
- K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)2Cleared 510(K)
- K250587Orthoscan TAU Mini C-Arm2Cleared 510(K)
- K243452Orthoscan VERSA Mini C-Arm2Cleared 510(K)
- K240828OEC One ASD2Cleared 510(K)
- K233669OEC 3D2Cleared 510(K)
- K213113Orthoscan Tau Mini C-Arm2Cleared 510(K)
- K203346OEC 3D2Cleared 510(K)
- K192819OEC Elite2Cleared 510(K)
- K190024Smart-C2Cleared 510(K)
- K183220OrthoScan TAU Mini C-Arm2Cleared 510(K)
- K182626OEC One2Cleared 510(K)
- K170946Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant2Cleared 510(K)
- K172550OEC Elite2Cleared 510(K)
- K171800OEC Elite MiniView2Cleared 510(K)
- K163429B62Cleared 510(K)
- K160984MultiScan G-Arm System2Cleared 510(K)
- K160131OEC Elite MiniView2Cleared 510(K)
- K160065GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System2Cleared 510(K)
- K151280MultiScan G-Arm System2Cleared 510(K)
- K141672DIGIARC 100AU+2Cleared 510(K)
- K133174ORTHOSCAN FD MINI C-ARM2Cleared 510(K)
- K131423G-ARM MULTISCAN SYSTEM2Cleared 510(K)
- K123603OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME2Cleared 510(K)
- K121303MOBILE C-ARM2Cleared 510(K)
- K120613OEC 9900 ELITE2Cleared 510(K)
- K120388INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM2Cleared 510(K)
- K113708ORTHOSCAN MOBILE DI MINI C-ARM2Cleared 510(K)
- K092564O-ARM IMAGING SYSTEM2Cleared 510(K)
- K061873VERT-X2Cleared 510(K)
- K060344O-ARM IMAGING SYSTEM2Cleared 510(K)
- K051754ORTHOSCAN, ORTHOSCAN HD2Cleared 510(K)
- K051490GE OEC EVERVIEW 75002Cleared 510(K)
- K051133ARCADIS AVANTIC2Cleared 510(K)
- K050996O-ARM IMAGING SYSTEM2Cleared 510(K)
- K043379SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-2002Cleared 510(K)
- K0412133DSCOPE2Cleared 510(K)
- K040347SIREMOBIL ISO-C 3D2Cleared 510(K)
- K040066SIREMOBILE C062Cleared 510(K)
- K033066XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM2Cleared 510(K)
- K013426MOONRAY MOBILE C-ARM2Cleared 510(K)
- K010762PHILIPS BV LIBRA2Cleared 510(K)
- K010393APOLLO MOBILE C ARM SYSTEM2Cleared 510(K)
- K003837FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM2Cleared 510(K)
- K003568XISCAN 6000 IMAGING SYSTEM2Cleared 510(K)
- K003266SIREMOBIL ISO-C 3D2Cleared 510(K)
- K993092SONADA ULTRASOUND SYSTEM2Cleared 510(K)
- K992506MINI 6800 DIGITAL MOBILE C-ARM2Cleared 510(K)
- K984406XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM2Cleared 510(K)
- K982706PHILIPS BV300 SERIES RELEASE 2.12Cleared 510(K)
- K981131PATHFINDER MOBILE C ARM2Cleared 510(K)
- K980322ACCENT 16, ACCENT 222Cleared 510(K)
- K973598SIREMOBIL CO22Cleared 510(K)
- K965013DIGISCOPE RX-2 (9 OPTION)2Cleared 510(K)
- K963093SIREMOBIL COMPACT2Cleared 510(K)
- K960907ORCA2Cleared 510(K)
- K955251OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM2Cleared 510(K)
- K960198DIGISCOPE RX-22Cleared 510(K)
- K953910PHILIPS BV 300 SERIES2Cleared 510(K)
- K951765SERIES 6600 DIGITAL MOBILE C-ARM2Cleared 510(K)
- K940294SHIMADZU MOBILE X-RAY SYSTEMS2Cleared 510(K)
- K935580PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER2Cleared 510(K)
- K934700MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY2Cleared 510(K)
- K933431ORTHOTRAC COAXIAL LASER2Cleared 510(K)
- K933447STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM2Cleared 510(K)
- K9260569600 FLUOROSCOPIC IMAGING SYSTEM2Cleared 510(K)
- K914748COMET C-1252Cleared 510(K)
- K921255PHILIPS BV26 MOBILE C-ARM STAND2Cleared 510(K)
- K913525MOBILE X-RAY SYSTEM2Cleared 510(K)
- K911739SWEMAC REISON BIPLANAR 3002Cleared 510(K)
- K910115PHILIPS BV-29 IMAGING SYSTEM2Cleared 510(K)
- K900967MODIFIED ALPHA MC-9R C-ARM2Cleared 510(K)
- K900193MTHF-9R MOBIL C-ARM IMAGE INTENSIFIER UNIT2Cleared 510(K)
- K900194MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT2Cleared 510(K)
- K896387SXT-60F/60M MOBILE C ARM X-RAY UNIT2Cleared 510(K)
- K8929341 VIDEO TAPE RECORDER MODEL BK-224 H2Cleared 510(K)
- K893617MOBILE C-ARM2Cleared 510(K)
- K880518MOBILE C-ARM OMNI 3252Cleared 510(K)
- K820658LIXISCOPE - OR LIXI2Cleared 510(K)
- K760429FLOUROSCOPE, MOBILE C-ARM IMAGE INTENS.2Cleared 510(K)
- PCSLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox2Product Code
- PGYDisplay, Diagnostic Radiology2Product Code
- POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2Product Code
- QASRadiological Computer-Assisted Triage And Notification Software2Product Code
- QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture2Product Code
- QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer2Product Code
- QFMRadiological Computer-Assisted Prioritization Software For Lesions2Product Code
- QHAX-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device2Product Code
- QHXFluoroscopic X-Ray Image Intensifier1Product Code
- QHYSolid State Fluoroscopic X-Ray Imager2Product Code
- QIHAutomated Radiological Image Processing Software2Product Code
- QJUImage Acquisition And/Or Optimization Guided By Artificial Intelligence2Product Code
- QKBRadiological Image Processing Software For Radiation Therapy2Product Code
- RCCC-Arm Fluoroscopic X-Ray System2Product Code
- QTZRadiological Image Processing Software For Ablation Therapy Planning And Evaluation2Product Code
- QXLCabinet, Emission Computed Tomography System2Product Code
- SFVX-Ray, Computed Tomography, Cone-Beam2Product Code
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K160065
- 510(k) Type
- Traditional
- Applicant
- GEMSS MEDICAL SYSTEMS CO., LTD
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/20/2016
- Days to Decision
- 128 days
- Submission Type
- Summary