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
- K241249Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)2Cleared 510(K)
- K233806T2 Plus2Cleared 510(K)
- K240855Dental Cone-beam Computed Tomography2Cleared 510(K)
- K232710Dental Cone-beam Computed Tomography2Cleared 510(K)
- K230985Planmeca Viso2Cleared 510(K)
- K231181bright CT2Cleared 510(K)
- K232487Provecta 3D Prime and Provecta 3D Prime Ceph2Cleared 510(K)
- K232166PreXion3D Expedition2Cleared 510(K)
- K232287RAYSCAN a-Expert3D2Cleared 510(K)
- K231796Grreen X 12 (Model: PHT-75CHS)2Cleared 510(K)
- K222666X-View 3D Pan/X-View 2D Pan2Cleared 510(K)
- K230505Orthopantomograph™ OP 3D LX2Cleared 510(K)
- K230753RCT8002Cleared 510(K)
- K223816Dental CT Scanner AXR2Cleared 510(K)
- K223794hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS2Cleared 510(K)
- K222150PreXion3D Expedition2Cleared 510(K)
- K222219R2 Studio Q/RCT8202Cleared 510(K)
- K221525PreXion3D Explorer PRO2Cleared 510(K)
- K220392PAPAYA 3D & PAPAYA 3D Plus2Cleared 510(K)
- K213278Planmed Verity2Cleared 510(K)
- K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph2Cleared 510(K)
- K214084hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS2Cleared 510(K)
- K211159eco-x Series (eco-x, eco-x-s)2Cleared 510(K)
- K213226RCT7002Cleared 510(K)
- K212254DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)2Cleared 510(K)
- K212303T22Cleared 510(K)
- K210820EAGLE EDGE AXR90 and AXR1202Cleared 510(K)
- K200270rainbow MCT2Cleared 510(K)
- K200271rainbow CT2Cleared 510(K)
- K203784PreXion3D Explorer PRO2Cleared 510(K)
- K210329Green X 18(Model : PHT-75CHS)2Cleared 510(K)
- K2013783D Accuitomo 150N2Cleared 510(K)
- K203797vatech A9 (Model : PHT-30CSS)2Cleared 510(K)
- K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)2Cleared 510(K)
- K201627Dental Computed Tomography X-Ray System, Green X2Cleared 510(K)
- K200469PAPAYA 3D Premium & PAPAYA 3D Premium Plus2Cleared 510(K)
- K201667Midmark Extraoral Imaging System (EOIS)2Cleared 510(K)
- K201140Axeos2Cleared 510(K)
- K200688hyperion X5, NewTom GO, X-RADiUS COMPACT2Cleared 510(K)
- K193329PreXion3D Explorer EX2Cleared 510(K)
- K200183CS 96002Cleared 510(K)
- K193139ProVecta 3D Prime Ceph2Cleared 510(K)
- K192737RCT8002Cleared 510(K)
- K190856SeeFactorCT32Cleared 510(K)
- K183475T1-CS, T1-C2Cleared 510(K)
- K191616Orthophos S2Cleared 510(K)
- K190812RAYSCAN a-Expert3D2Cleared 510(K)
- K190496hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS2Cleared 510(K)
- K190320PreXion3D Explorer2Cleared 510(K)
- K182805RCT8002Cleared 510(K)
- K180918Planmed Verity2Cleared 510(K)
- K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)2Cleared 510(K)
- K182614RCT7002Cleared 510(K)
- K181576Planmeca Viso2Cleared 510(K)
- K181983PreXion 3D Excelsior2Cleared 510(K)
- K181432ProVectra 3D Prime with VistaSoft2Cleared 510(K)
- K181452RCT8002Cleared 510(K)
- K180947Orthopantomograph OP 3D2Cleared 510(K)
- K181136CS 96002Cleared 510(K)
- K173878PreXion3D Excelsior2Cleared 510(K)
- K171012Veraview X8002Cleared 510(K)
- K163423Orthopantomograph OP3002Cleared 510(K)
- K170066Green16/Green18 (Model: PHT-65LHS)2Cleared 510(K)
- K170813ORTHOPANTOMOGRAPH OP 3D2Cleared 510(K)
- K161900HYPERION X52Cleared 510(K)
- K160166X-MIND trium2Cleared 510(K)
- K162085i-CAT FLX V series / KaVo 3D eXam+ V series2Cleared 510(K)
- K160882PaX-i3D Green Premium (Model: PCT-90LH)2Cleared 510(K)
- K162660Green Smart (Model: PHT-35LHS)2Cleared 510(K)
- K161881PreXion3D Excelsior2Cleared 510(K)
- K160140DENTRIa series2Cleared 510(K)
- K160525RCT7002Cleared 510(K)
- K151137X-VIEW, IMAGEN2Cleared 510(K)
- K160506Planmeca ProMax 3D Max, Planmeca Maximity2Cleared 510(K)
- K151612NewTom VGi evo2Cleared 510(K)
- K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray2Cleared 510(K)
- K150354PAPAYA 3D Plus2Cleared 510(K)
- K152106Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart2Cleared 510(K)
- K143435Planmed Verity2Cleared 510(K)
- K150217ORTHOPHOS SL2Cleared 510(K)
- K142247RAYSCAN A-EXPERT 3D2Cleared 510(K)
- K133797QMASTER-H/REVO2Cleared 510(K)
- K132983TON-95LH, PAX-I3D ORTHO2Cleared 510(K)
- K133620CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM2Cleared 510(K)
- K133544OP3002Cleared 510(K)
- K133406CS 8100 3D2Cleared 510(K)
- K131695RAYSCAN A-EXPERT 3D2Cleared 510(K)
- K123332NAOMI-CT2Cleared 510(K)
- K130442NEWTOM VGI AND NEWTOM 5G2Cleared 510(K)
- K130443I-MAX TOUCH 3D2Cleared 510(K)
- K130432PHT-6500, PHT-60CFO2Cleared 510(K)
- K130297SCANORA 3DX2Cleared 510(K)
- K123381HYPERION X92Cleared 510(K)
- K122199PREXION3D ECLIPSE2Cleared 510(K)
- K123070GALILEOS FAMILY2Cleared 510(K)
- K122981RAYSCAN A-EXPERT 3D2Cleared 510(K)
- K120948PREXION 3D2Cleared 510(K)
- K122018OP3002Cleared 510(K)
- K122606PHT-6500; PHT-60CFO; PAX-I3D2Cleared 510(K)
- K121400PAX-UNI3D, PHT-75002Cleared 510(K)
- K120753CLARISCT2Cleared 510(K)
- K121412PAX-FLEX3D, PHT-70002Cleared 510(K)
- K121236PAX-DUO3D PLUS, PCT-50002Cleared 510(K)
- K103659CS 9300, CS 9300C2Cleared 510(K)
- K101181BEL-CAT2Cleared 510(K)
- K110839SCANORA 3D2Cleared 510(K)
- K110260NEWTOM 5G / NEWTOM 5G VERSION FP2Cleared 510(K)
- K102196COMPUTED TOMOGRAPHY X-RAY SYSTEM2Cleared 510(K)
- K103711ORTHOPHOS XG 3D / CEPH2Cleared 510(K)
- K090467DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D2Cleared 510(K)
- K083917X-RAY, TOMOGRAPHY, COMPUTED, DENTAL2Cleared 510(K)
- K090171COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D2Cleared 510(K)
- K082410MASTER3DS2Cleared 510(K)
- K082350PAX-5002Cleared 510(K)
- K063622FINECUBE DENTAL CT2Cleared 510(K)
- K063773VOLUMETRIC TOMOGRAPHY2Cleared 510(K)
- K041137NEWTOM 3G QR-DVT 90002Cleared 510(K)
- K003787NEWTOM QR-DVT 90002Cleared 510(K)
- 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
- PGYDisplay, Diagnostic Radiology2Product Code
- POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2Product Code
- QASRadiological Computer-Assisted Triage And Notification Software2Product 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
- 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
- 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
X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K201382
- 510(k) Type
- Abbreviated
- Applicant
- de Gotzen S.r.l.
- Country
- Italy
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/18/2020
- Days to Decision
- 176 days
- Submission Type
- Summary