Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- FCPBox, Battery, Pocket1Product Code
- FCQLight Source, Incandescent, Diagnostic2Product Code
- EXQCystometer, Electrical Recording2Product Code
- EXRUrinometer, Mechanical2Product Code
- EXSUrinometer, Electrical2Product Code
- EXWPill, Radio2Product Code
- EXYUroflowmeter2Product Code
- EXZEquipment, Photographic, For Physiologic Function Monitor1Product Code
- FAJCystoscope And Accessories, Flexible/Rigid2Product Code
- FAKPanendoscope (Gastroduodenoscope)2Product Code
- FALPanendoscope (Urethroscope)2Product Code
- FAMSigmoidoscope And Accessories, Flexible/Rigid2Product Code
- FANSigmoidoscope, Rigid, Electrical2Product Code
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device2Product Code
- FBIRongeur, Cystoscopic2Product Code
- FBKEndoscopic Injection Needle, Gastroenterology-Urology2Product Code
- FBNCholedochoscope And Accessories, Flexible/Rigid2Product Code
- FBOCystourethroscope2Product Code
- FBPTelescope, Rigid, Endoscopic2Product Code
- FCCEndoscopic Magnetic Retriever2Product Code
- FCFInstrument, Biopsy, Mechanical, Gastrointestinal2Product Code
- FCGBiopsy Needle2Product Code
- FCIPunch, Biopsy2Product Code
- FCKInstrument, Biopsy, Suction2Product Code
- FCLForceps, Biopsy, Non-Electric1Product Code
- FCOBox, Battery, Rechargeable1Product Code
- FCRLight Source, Photographic, Fiberoptic2Product Code
- FCWLight Source, Fiberoptic, Routine2Product Code
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope2Product Code
- FCYBulb, Inflation, For Endoscope1Product Code
- FCZTube, Smoke Removal, Endoscopic1Product Code
- FDAEnteroscope And Accessories2Product Code
- FDCResectoscope, Working Element2Product Code
- FDELaparoscopy Kit2Product Code
- FDFColonoscope And Accessories, Flexible/Rigid2Product Code
- FDRSphyncteroscope2Product Code
- FDSGastroscope And Accessories, Flexible/Rigid2Product Code
- FDTDuodenoscope And Accessories, Flexible/Rigid2Product Code
- FDWEsophagoscope, Rigid, Gastro-Urology2Product Code
- FDXEndoscopic Cytology Brush2Product Code
- FDYDevice, Measuring, For Panendoscope1Product Code
- FDZAttachment, Eyepiece, For Insertion Of Prescription Lens1Product Code
- FEAAttachment, Teaching, For Endoscope1Product Code
- FECObturator, For Endoscope2Product Code
- FEDEndoscopic Access Overtube, Gastroenterology-Urology2Product Code
- FEIInstrument, Special Lens, For Endoscope1Product Code
- FEJAttachment, Binocular, For Endoscope1Product Code
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)1Product Code
- FENDevice, Cystometric, Hydraulic2Product Code
- FEQPump, Air, Non-Manual, For Endoscope2Product Code
- FERAnoscope And Accessories2Product Code
- FESRecorder, External, Pressure, Amplifier & Transducer2Product Code
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology2Product Code
- K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)2Cleared 510(K)
- K241371VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)2Cleared 510(K)
- K222584EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-11002Cleared 510(K)
- K212808Logic Hd camera head green, System green2Cleared 510(K)
- K221174Telepack +2Cleared 510(K)
- K211332D Camera Controller2Cleared 510(K)
- K202646Visera Elite II Video System Center2Cleared 510(K)
- K201135Image1 S CCU, Image1 S 4U Camera Head2Cleared 510(K)
- K201200Visera Elite II Video System Center2Cleared 510(K)
- K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 55252Cleared 510(K)
- K192286FUJIFILM EP-6000 Video Processor2Cleared 510(K)
- K193235Telepack +2Cleared 510(K)
- K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head2Cleared 510(K)
- K190648Pusen Eview Medical Video Endoscope Image Processor2Cleared 510(K)
- K182696Telepack X LED2Cleared 510(K)
- K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD2Cleared 510(K)
- K180414EPX-4440FN Digital Video Processor with Light Source2Cleared 510(K)
- K1728174K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA2Cleared 510(K)
- K163675Processor VP-7000, Light Source BL-70002Cleared 510(K)
- K161204ENDOCAM Flex HD Camera System 55212Cleared 510(K)
- K160044Image1 SPIES System2Cleared 510(K)
- K152109HD-Camera HDC10002Cleared 510(K)
- K150221EPX-4440HD and EPX-4400HD with FICE2Cleared 510(K)
- K131953IMAGE1 SPIES2Cleared 510(K)
- K130423THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 55252Cleared 510(K)
- K113873PENTAX EPK-I5020 VIDEO PROCESSOR2Cleared 510(K)
- K111997IMAGE1 GI CCU MODEL 22203020-1142Cleared 510(K)
- K102949COLONOSCOPY ASSISTANT2Cleared 510(K)
- K102466FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR2Cleared 510(K)
- K102059AUTOCLAVABLE CAMER HEAD MODEL OTV-Y00172Cleared 510(K)
- K090800VS-100 ILLUMINATION AND IMAGING SYSTEM2Cleared 510(K)
- K083155HD CAMERA HEAD OTV-S7PROH-HD-L08E2Cleared 510(K)
- K080809IEC MEDSIGHT AND MEDBRIGHT2Cleared 510(K)
- K081585ENDOSCOPY VIDEO CAMERA SYSTEM2Cleared 510(K)
- K070716IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL2Cleared 510(K)
- K043324AIDA WITH DICOM AND HL7 INTERFACE2Cleared 510(K)
- K041494OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 22Cleared 510(K)
- K031895KSEA OPSERVER LAP2Cleared 510(K)
- K032544VP-1000; MED CAM 100; VP-3000A; MED CAM 3002Cleared 510(K)
- K032545ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 2502Cleared 510(K)
- K0236591-CCD ENDOCAM 5520 SYSTEM2Cleared 510(K)
- K020301MODIFICATION TO VISTA STEREOSCOPE SYSTEM2Cleared 510(K)
- K012660GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES2Cleared 510(K)
- K013709HILL-ROM PRIMAVIEW MONITOR SYSTEM2Cleared 510(K)
- K003325KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM2Cleared 510(K)
- K003113KSEA SCB-RUI SCO2Cleared 510(K)
- K003710DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 72079052Cleared 510(K)
- K994348KSEA SCB-RUI2Cleared 510(K)
- K994090KARL STORZ AUTOCLAVABLE CAMERA HEAD2Cleared 510(K)
- K992469KSEA SCBCOM2Cleared 510(K)
- K992362FLEXISCOPE IQ 1012Cleared 510(K)
- K981856MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)2Cleared 510(K)
- K981827VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM2Cleared 510(K)
- K973798S-357 VIDEO IMAGING SYSTEM2Cleared 510(K)
- K973252KARL STORZ DIRECT COUPLED CAMERA HEAD2Cleared 510(K)
- K972540S-357 VIDEO IMAGING SYSTEM2Cleared 510(K)
- K971416OLYMPUS OES OTV-S5C VIDEO SYSTEM2Cleared 510(K)
- K971373VISTA SINGLE CHIP VIDEO CAMERA2Cleared 510(K)
- K964173C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ2Cleared 510(K)
- K962024S-57 VIDEO IMAGING SYSTEM2Cleared 510(K)
- K954451EVIS 140 SYSTEM2Cleared 510(K)
- K954734THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM (MODIFICATION)2Cleared 510(K)
- K952482KSEA REVERSE VIDEO2Cleared 510(K)
- K950417EPX-310 VIDEO PROCESSOR (ENDOSCOPY)2Cleared 510(K)
- K950975KARL STORZ ENDOVISION TWINVIDEO (DIGITAL PICTURE-IN-PICTURE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENS2Cleared 510(K)
- K950974KARL STORZ ENDOVISION DIGIVIDEO (DIGITAL IMAGE PROCESSOR) ACCESSORY FOR COLOR TELEVISION CAMERA USED IN ENDOSCOPIC PROCS2Cleared 510(K)
- K944620SERIES 400 GASTROENTEROLOGY SYSTEM2Cleared 510(K)
- K944759200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM2Cleared 510(K)
- K944254OKTAS STEREO VIEWING SYSTEM2Cleared 510(K)
- K944081OLYMPUS SWITCHING UNIT MODEL SU-12Cleared 510(K)
- K940283KARL STORZ ENDOVISION UROCAM/HYSTEROCAM2Cleared 510(K)
- K941919OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM2Cleared 510(K)
- K942141EIDOLON ENDOSCOPE COUPLER2Cleared 510(K)
- K932312FUJINON VIDEO LAPAROSCOPE -- MODIFIED2Cleared 510(K)
- K934918EPM-3300 VIDEO PROCESSOR2Cleared 510(K)
- K934623ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA2Cleared 510(K)
- K920026NOBLES-LAI IMAGING SYSTEM2Cleared 510(K)
- K912447SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 52002Cleared 510(K)
- K912531IMD MULTICAM 1000/2000 VIDEO CAMERA SYSTEMS2Cleared 510(K)
- K911485COLOR VIDEO CAMERA2Cleared 510(K)
- K903459PRECISION OPTICS ENDOSCOPE ADAPTER2Cleared 510(K)
- K903457PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)2Cleared 510(K)
- K903458PRECISION OPTICS IMAGE COUPLER2Cleared 510(K)
- K900380MEDILASE 5010 ENDOSCOPE CONSOLE2Cleared 510(K)
- K870680OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)2Cleared 510(K)
- K853585OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS2Cleared 510(K)
- K843198VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y2Cleared 510(K)
- K831412CRM-100 COLOR VIDEO CAMERA2Cleared 510(K)
- K830924CRM-114 COLOR VIDEO CAMERA2Cleared 510(K)
- K822959ENDOSCOPIC VIDEOSYSTEM2Cleared 510(K)
- K820624SYN-OPTICS #52002Cleared 510(K)
- K810393ENDOSCOPIC CLOSED CIRCUIT COLOR TV SYST.2Cleared 510(K)
- FFFCover, Biopsy Forceps1Product Code
- FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable2Product Code
- FFSImage, Illumination, Fiberoptic, For Endoscope2Product Code
- FFTElectrode, Ph, Stomach1Product Code
- FFXSystem, Gastrointestinal Motility (Electrical)2Product Code
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope1Product Code
- FFZCord, Electric, For Endoscope2Product Code
- FGAKit, Nephroscope2Product Code
- FGBUreteroscope And Accessories, Flexible/Rigid2Product Code
- FGCUrethroscope2Product Code
- FGSCarrier, Sponge, Endoscopic2Product Code
- FHOPneumoperitoneum Needle2Product Code
- FHPNeedle, Pneumoperitoneum, Simple2Product Code
- FHXJelly, Lubricating, For Transurethral Surgical Instrument2Product Code
- FJLResectoscope2Product Code
- FTILamp, Endoscope, Incandescent2Product Code
- FTJColonoscope, General & Plastic Surgery2Product Code
- GCFProctoscope2Product Code
- GCKGastroscope, General & Plastic Surgery2Product Code
- GCLEsophagoscope, General & Plastic Surgery2Product Code
- GCMEndoscope, Rigid2Product Code
- GCNEndoscope, Prism2Product Code
- GCOEndoscope, Mirror2Product Code
- GCPEndoscope, Ac-Powered And Accessories2Product Code
- GCQEndoscope, Flexible2Product Code
- GCSEndoscope, Battery-Powered And Accessories2Product Code
- GCTLight Source, Endoscope, Xenon Arc2Product Code
- GCWTransformer, Endoscope2Product Code
- GDBEndoscope, Fiber Optic2Product Code
- KDMSigmoidoscope, Rigid, Non-Electrical2Product Code
- KDORongeur, Cystoscopic, Hot2Product Code
- KGDScissors For Cystoscope2Product Code
- KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube2Product Code
- KNWInstrument, Biopsy2Product Code
- MNKEndoscopic Bite Block1Product Code
- MNLAccessories, Cleaning Brushes, For Endoscope1Product Code
- MYESystem, Electrogastrography (Egg)2Product Code
- NBGMarker, Colon2Product Code
- NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule2Product Code
- NLMLaparoscope, General & Plastic Surgery, Reprocessed2Product Code
- NLSInstrument, Biopsy, Reprocessed2Product Code
- NLXNeedle, Pneumoperitoneum, Spring Loaded, Reprocessed2Product Code
- NMXNeedle And Needle Set, Gastro-Urology, Reprocessed2Product Code
- NMYNeedle, Endoscopic, Reprocessed2Product Code
- NONForceps, Biopsy, Non-Electric, Reprocessed1Product Code
- NSISystem, Imaging, Esophageal, Wireless, Capsule2Product Code
- NTNLed Light Source2Product Code
- NWBEndoscope, Accessories, Narrow Band Spectrum2Product Code
- NYVGastrointestinal Motility System, Capsule2Product Code
- NWSKit, Choledochoscope, Flexible And Rigid2Product Code
- NWTEndoscopic Cholangiogram Kit2Product Code
- NWUEndoscope Introducer Kit2Product Code
- OCSEndoscopic Video Imaging System/Component, Gastroenterology-Urology2Product Code
- OCTAnti Fog Solution And Accessories, Endoscopy2Product Code
- OCUEndoscopic Storage Cover2Product Code
- OCVEndoscope Holder2Product Code
- OCWEndoscopic Tissue Approximation Device2Product Code
- OCXEndoscopic Irrigation/Suction System2Product Code
- OCYEndoscopic Guidewire, Gastroenterology-Urology2Product Code
- OCZEndoscopic Grasping/Cutting Instrument, Non-Powered2Product Code
- ODAEndoscopic Central Control Unit2Product Code
- ODBEndoscopic Contamination Prevention Sheath2Product Code
- ODCEndoscope Channel Accessory2Product Code
- ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula2Product Code
- ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)2Product Code
- ODFMini Endoscope, Gastroenterology-Urology2Product Code
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology2Product Code
- PCVEndoscopic Leak Tester2Product Code
- PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement2Product Code
- PGDColon Capsule Imaging System2Product Code
- PGUSpatial Imaging For Display Of Endoscope Position2Product Code
- PHTBasin For Endoscope Reprocessing1Product Code
- PLLSubmucosal Injection Agent2Product Code
- POZBiopsy Needle Kit2Product Code
- PPENephroscope Set2Product Code
- PRVGastro-Urology Biopsy Kit2Product Code
- PTQEndoscopic Magnetic Retriever, Exempt2Product Code
- QFZGastroenterology-Urology Accessories To A Biopsy Instrument1Product Code
- PTRScissors For Cytoscope, Exempt2Product Code
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt2Product Code
- QIJEndoscopic Transhepatic Venous Access Needle2Product Code
- QISEsophageal, Mucosal, Electrical Characterization2Product Code
- QKZMagnetically Maneuvered Capsule Endoscopy System2Product Code
- QNPGastrointesinal Lesion Software Detection System2Product Code
- SBXSoftware For Endoscopy Procedure Metrics2Product Code
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- 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
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
EPX-4440HD and EPX-4400HD with FICE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K150221
- 510(k) Type
- Traditional
- Applicant
- FUJIFILM MEDICAL SYSTEM U.S.A., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/1/2015
- Days to Decision
- 244 days
- Submission Type
- Summary