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
- K994329IIVS INTEGRATED IMAGE VIEWING STATION1Cleared 510(K)
- K992698STENTOR, PAGEVIEW1Cleared 510(K)
- K992426RAYPAX WEB CLINICAL SYSTEM1Cleared 510(K)
- K992352ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.01Cleared 510(K)
- K991537SAMSUNG RAYPAX SYSTEM1Cleared 510(K)
- K984000STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM1Cleared 510(K)
- K974707IMAGEQUEST1Cleared 510(K)
- K981053KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW1Cleared 510(K)
- K980918JPACS1Cleared 510(K)
- K974882DOWNSCAN LT1Cleared 510(K)
- K980684VR NETSERVE1Cleared 510(K)
- K980541BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY1Cleared 510(K)
- K980241NETCO MEDICAL DATA TRANSPORTATION SERVICE SOFTWARE1Cleared 510(K)
- K980220IISYS PACS SYSTEM1Cleared 510(K)
- K974130VISISHARE IMAGING SYSTEM AND/ OR SOFTWARE, VISISHARE SYSTEM AND/ OR SOFTWARE1Cleared 510(K)
- K974255CD-R STATION AND VRS-20001Cleared 510(K)
- K974107KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)1Cleared 510(K)
- K974102MILTRA IMAGING INC., IMAGE VAULT1Cleared 510(K)
- K973805IMAGEACCESS SYSTEM1Cleared 510(K)
- K972701BARCO MWD 321 MEDICAL WORKSTATION DISPLAY1Cleared 510(K)
- K973959OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE1Cleared 510(K)
- K973793OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE1Cleared 510(K)
- K973421IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}1Cleared 510(K)
- K972925ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC1Cleared 510(K)
- K973239DICOM 3.0 SOFTWARE VERSION 2.01Cleared 510(K)
- K973303IMATION MODEL 9410 NETWORK INTERFACE1Cleared 510(K)
- K973131SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY)1Cleared 510(K)
- K973090MEDSTATION1Cleared 510(K)
- K972366IMNET DICOM NETWORK AGENT1Cleared 510(K)
- K972191DIGITIZER DIRECTOR (HSC025-01)1Cleared 510(K)
- K971347MEDISURF1Cleared 510(K)
- K971154MULTIPICS(ME-977)1Cleared 510(K)
- K971153SPLITSCREEN (ME-975)1Cleared 510(K)
- K970628GE ADVANTAGE DIGITIZER WORKSTATION1Cleared 510(K)
- K970652MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE1Cleared 510(K)
- K970641RIS SCANVIEW SYSTEM (RSVS)1Cleared 510(K)
- K970174FREEPIX/PIXPACS DICOM/HTTP GATEWAY1Cleared 510(K)
- K970293FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM6661Cleared 510(K)
- K970064AMICAS WEB/INTRANET IMAGE SERVER1Cleared 510(K)
- K965161SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)1Cleared 510(K)
- K964250LINX NETWORKING SYSTEM1Cleared 510(K)
- K963861LASERSHARE PRINT SPOOLER AND/OR SOFTWARE1Cleared 510(K)
- K963628IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE1Cleared 510(K)
- K963594IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)1Cleared 510(K)
- K963592IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 20001Cleared 510(K)
- K962225VIEWSEND MEDICAL MODEL 12001Cleared 510(K)
- K961023AIDP(ACCUIMAGE IMAGE DISPLAY PROCESSOR)1Cleared 510(K)
- K962699RADWORKS MEDICAL IMAGING SOFTWARE1Cleared 510(K)
- K961689INFINET1Cleared 510(K)
- K961753SHARED VISION(PART NUMBER SV 0015)1Cleared 510(K)
- K960911NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE1Cleared 510(K)
- K960382KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER1Cleared 510(K)
- K954567RTI MEDICAL1Cleared 510(K)
- K960809PHILIPS SITE VIEW WORKSTATION1Cleared 510(K)
- K954691ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM1Cleared 510(K)
- K954172X-RAY VISIONS1Cleared 510(K)
- K955708COMPUMED DICON CLIENT1Cleared 510(K)
- K954071IDXVIEW1Cleared 510(K)
- K954479DICOMVIEW1Cleared 510(K)
- K955000REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE1Cleared 510(K)
- K950513ARCHIVEMANAGER1Cleared 510(K)
- K954008REDI-VU SYSTEMS (SEND & RECEIVE)1Cleared 510(K)
- K953552SIENET SPI SPOOLER1Cleared 510(K)
- K953371LUMISYS DICOM TOOKLIT1Cleared 510(K)
- K953514COURIER II1Cleared 510(K)
- K953398UNISCAN1Cleared 510(K)
- K953080DIGITAL IMAGING SYSTEM INTERFACE1Cleared 510(K)
- K953163QUICK READ 2000 (QR2000)1Cleared 510(K)
- K952914STAR TECHNOLOGIES, INC. FILM IMAGE SCAN SYSTEM1Cleared 510(K)
- K952533SIENET DICOM GATEWAY1Cleared 510(K)
- K951175MEDICAL IMAGING INFORMATION AND CAPTURE SYSTEM (MIICS)1Cleared 510(K)
- K950413MEDIPACS1Cleared 510(K)
- K952484MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A1Cleared 510(K)
- K943994PACS EQUIPMENT1Cleared 510(K)
- K950431LOSSLESS TELERADIOLOGY OPTION FOR USE WITH IES, IMAGE ENHANCEMENT SYSTEM1Cleared 510(K)
- K950699PREVIEW TELEIMAGING SYSTEM1Cleared 510(K)
- K950343HYPERPACS PACS AND TELERAFIOLOGY SYSTEM1Cleared 510(K)
- K944322AT&T IMAGE SOLUTIONS PICASSO STILL-IMAGE PHONE SYSTEM1Cleared 510(K)
- K925964IMAGE TRANSPORT SERIES III1Cleared 510(K)
- K940859PACSPRO I1Cleared 510(K)
- K944771INTRASCAN II1Cleared 510(K)
- K944130RIT 531 TELERADIOLOGY/ PAC SYSTEM1Cleared 510(K)
- K941224LENZAR REMOTE ACQUISITION SYSTEM1Cleared 510(K)
- K942861MEDVISION ENVIROMENT/MEDVISION 2.01Cleared 510(K)
- K943383IMAGING WORKBENCH1Cleared 510(K)
- K943158AD/V IMAGEPLEX(TM)1Cleared 510(K)
- K942917ULTRAPRO WORKSTATION1Cleared 510(K)
- K940423NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE1Cleared 510(K)
- K941203MEDICAL IMAGING WORKSTATION II (MIW II)1Cleared 510(K)
- K941086PACSPRO II1Cleared 510(K)
- K940408REMOTE CONSOLE1Cleared 510(K)
- K9361533M 1156 MULTI-INPUT SYSTEM1Cleared 510(K)
- K936116KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS1Cleared 510(K)
- K935103VISIONLINK ACR-NEMA CONVERSION UTILITIES1Cleared 510(K)
- K934386IMPAX 50001Cleared 510(K)
- K930500MAXIVIEW DIAGNOSTIC WORKSTATION1Cleared 510(K)
- K926315PRACTICE PARTNER1Cleared 510(K)
- K931186PHOTOPHONE MULTIVIEW1Cleared 510(K)
- K931795TELERAD STAT1Cleared 510(K)
- K933409IMPAX 10001Cleared 510(K)
- K933103DIGITAL IMAGE COMMUNICATIONS SYSTEM1Cleared 510(K)
- K933098MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL1Cleared 510(K)
- K925864COURIER PC1Cleared 510(K)
- K931292MULTIVIEW FOR WINDOWS1Cleared 510(K)
- K931551KODAK EKTASCAN IMAGELINK SYSTEM (KEIS)1Cleared 510(K)
- K926098DIGIRAY1Cleared 510(K)
- K931060STATVIEW1Cleared 510(K)
- K925050PC TELERADIOLOGY(TM)1Cleared 510(K)
- K930350RADMAN IMAGE MANAGMENT SYSTEM1Cleared 510(K)
- K930997DOMINATOR RADIOLOGY SYSTEM1Cleared 510(K)
- K921185TELEMEDIC TELERADIOLOGY SYSTEM1Cleared 510(K)
- K925994RSTAR IMAGE MANAGMENT SYTEM (RSTAR-IMS)1Cleared 510(K)
- K925929RSTAR INTENSIVE CARE UNIT MINI-PACS(ICU MINI-PACS)1Cleared 510(K)
- K924178MEDVISION(TM) IMAGING SOFTWARE1Cleared 510(K)
- K925284IMAGESSSHARE 9101Cleared 510(K)
- K922164RAYTEL DIGITAL IMAGING SYSTEMS1Cleared 510(K)
- K925097VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING)1Cleared 510(K)
- K924229VG-A MIG1Cleared 510(K)
- K923582SIENET CAMERA SERVER1Cleared 510(K)
- K921877AD/V SPOOLER1Cleared 510(K)
- K921527STATVIEW1Cleared 510(K)
- K9202683M DIGITAL DISK INTERFACE UNIT1Cleared 510(K)
- K921278M-2000 DIAGNOSTIC AND TELERADIOLOGY WORKSTATION1Cleared 510(K)
- K920310SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE1Cleared 510(K)
- K914444XPR PRINTER REDUNDANCY1Cleared 510(K)
- K914191XLP NETWORK PRINTING1Cleared 510(K)
- K911773PHILIPS TELESCAN1Cleared 510(K)
- K911405KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T1Cleared 510(K)
- K905199PACSNET RESEARCH TOOLKIT1Cleared 510(K)
- K900935DU PONT LINX LASER IMAGER W/THE LINX NETWORKING1Cleared 510(K)
- K896095IMAGES-ON-CALL TELERADIOLOGY SYSTEM1Cleared 510(K)
- K900227MVP (MULTI-VENDOR PROTOCOL CONVERTOR)1Cleared 510(K)
- K895209FILMFAX1Cleared 510(K)
- K891192MEDI-TRACE THERMAL VIDEO FILM PAPER1Cleared 510(K)
- K884434VORTECH'S MEDICAL IMAGING GATEWAY1Cleared 510(K)
- K882754REPORT AND IMAGE MANAGEMENT SYSTEM1Cleared 510(K)
- K873121GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)1Cleared 510(K)
- K871984KODAK EKTASCAN IMAGE TRANS. T1/R1 & P1 SOFTWARE1Cleared 510(K)
- K862158AVP TELEIMAGING SYSTEM1Cleared 510(K)
- K862744TELERADIOGRAPHY SYSTEM1Cleared 510(K)
- K862715COMMVIEW SYSTEM1Cleared 510(K)
- K850417INTERFACE MODULES IM 1000 IMAGE COMMUNI-NETWORK1Cleared 510(K)
- 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
- 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
IMPAX 5000
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K934386
- 510(k) Type
- Traditional
- Applicant
- HERAEUS KULZER, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/5/1994
- Days to Decision
- 119 days
- Submission Type
- Statement