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
- K132183DICOM VIDEO2Cleared 510(K)
- K130636TELERADPRO EDGE; TELERADPRO EDGE HD-CCD2Cleared 510(K)
- K130406DIAGNOSTICPRO EDGE2Cleared 510(K)
- K102476TELERADPRO2Cleared 510(K)
- K093809VIDAR DENTAL FILM DIGITIZER2Cleared 510(K)
- K091288MEDI-6000 MEDICAL IMAGE DIGITIZER2Cleared 510(K)
- K063424FILM DIGITZER, MODEL 2908 MAMMO PRO2Cleared 510(K)
- K042484NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER2Cleared 510(K)
- K033637MEDICAL IMAGE DIGITIZER, MODEL 29082Cleared 510(K)
- K032022DIGITAL IMAGER2Cleared 510(K)
- K022810COBRASCAN CR-1 FILMLESS2Cleared 510(K)
- K021949FULCRUM2Cleared 510(K)
- K020243LASERPRO 162Cleared 510(K)
- K013631EFILM VIDEO2Cleared 510(K)
- K013395LIFEJET VIDEO LINK2Cleared 510(K)
- K011049EXPRESSSUITE2Cleared 510(K)
- K00184135/CD CINECONVERTER2Cleared 510(K)
- K000411CHILI VIDEO, CHILI VIDEOPRO2Cleared 510(K)
- K992467IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM2Cleared 510(K)
- K993598MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 132052Cleared 510(K)
- K993599DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 130192Cleared 510(K)
- K993597PLLL, TELERADPRO, MODEL 12714/12715, VXR-12 PLUS, MODEL 8619/96172Cleared 510(K)
- K990066CCD CAMERA, MODEL 90002Cleared 510(K)
- K984409ELK LASER FILM DIGITIZER2Cleared 510(K)
- K984252IMATION TRIMATIC DIGITAL SYSTEM2Cleared 510(K)
- K982785FILM DIGITIZER MODEL 29052Cleared 510(K)
- K980873KONICA DIRECT DIGITIZER REGIUS MODEL 3302Cleared 510(K)
- K980809LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER2Cleared 510(K)
- K974315VIDAR VXR LS LASER FILM DIGITIZER2Cleared 510(K)
- K980565LD2000 SERIES2Cleared 510(K)
- K980213DI-20002Cleared 510(K)
- K974619SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM2Cleared 510(K)
- K973411DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)2Cleared 510(K)
- K971894KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM2Cleared 510(K)
- K970908HOWTEK 9602Cleared 510(K)
- K964288CALL-RAD PC TELERADIOLOGY2Cleared 510(K)
- K960839FILM SCANNER 3002Cleared 510(K)
- K961768KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)2Cleared 510(K)
- K953117SCANMASTER DX2Cleared 510(K)
- K954875ASPECT ACQUISITION MODULE (AAM)2Cleared 510(K)
- K953942COBRASCAN CX-3122Cleared 510(K)
- K952485LASERNET IMAGE MANAGER/PRINT SERVER2Cleared 510(K)
- K953964LUMISYS, LUMISCAN 202Cleared 510(K)
- K943357CEMAX SCANLINK V2Cleared 510(K)
- K932760DFS-21002Cleared 510(K)
- K925799AD/V A.52Cleared 510(K)
- K933830KONICA LD-4500 LASER DIGITIZER2Cleared 510(K)
- K933632MEDSCAN 122Cleared 510(K)
- K933129LUMISCAN 502Cleared 510(K)
- K925721KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE2Cleared 510(K)
- K924478MTV-250A, MTV-300A2Cleared 510(K)
- K911082REAL TIME X-RAY IMAGING SYSTEM2Cleared 510(K)
- K901423DIGITAL IMAGE SCANNER, MODEL DIS-10002Cleared 510(K)
- K896739KONICA KFDR-S2Cleared 510(K)
- K896223PHOTOPHONE2Cleared 510(K)
- K894412RADIOSCOPE OR MAMMOSCOPE2Cleared 510(K)
- K890970TRUVEL TZ-3X X-RAY DIGITIZING SCANNER2Cleared 510(K)
- K890477THE SPANTRON FRAME FREEZE2Cleared 510(K)
- K874778KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR2Cleared 510(K)
- K860777MATRIX LD & LD/LASER DIGITIZER2Cleared 510(K)
- K850330ANGIOTEC SC 1221 SCAN CONVERTER2Cleared 510(K)
- 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
- 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
FULCRUM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K021949
- 510(k) Type
- Traditional
- Applicant
- HOWTEK, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/12/2002
- Days to Decision
- 60 days
- Submission Type
- Summary