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
- K992131SAMSUNG RAYPAX LONG TERM ARCHIVE1Cleared 510(K)
- K984405ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-40001Cleared 510(K)
- K983447WISE (II) IMAGE MANAGEMENT SYSTEM1Cleared 510(K)
- K980243PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)1Cleared 510(K)
- K973463OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE1Cleared 510(K)
- K973413ID. STORE (RELEASE 2.0)1Cleared 510(K)
- K972380KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)1Cleared 510(K)
- K971848TDK MEDICAL GRADE CD-R1Cleared 510(K)
- K971451WISE IMAGE MANAGEMENT SYSTEM1Cleared 510(K)
- K963936ACCESSPOINT, MED E-MAIL, DICOM READER1Cleared 510(K)
- K964803UNIVISION ECHOCARDIOLOGY SYSTEM1Cleared 510(K)
- K964274WRITESTAR, AND VIEWSTAR1Cleared 510(K)
- K963395IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM1Cleared 510(K)
- K961680SONY DKR-700 DIGITAL STILL RECORDER1Cleared 510(K)
- K961160UPACS VERSION 1.71Cleared 510(K)
- K960981KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY1Cleared 510(K)
- K960941UPACS1Cleared 510(K)
- K951942LAST IMAGE HOLD1Cleared 510(K)
- K955237TIGERSCAN/TIGERVIEW1Cleared 510(K)
- K960326FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM1Cleared 510(K)
- K952238VIDCAS (VIDEO CAPTURE AND ARCHIVING SOFTWARE)1Cleared 510(K)
- K955184ACCULUPE1Cleared 510(K)
- K955232NT SERIES DIGITAL IMAGE MANAGER1Cleared 510(K)
- K950630WALLACH DIGITAL IMAGING SYSTEM1Cleared 510(K)
- K952888OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS1Cleared 510(K)
- K950279TOMTECP901Cleared 510(K)
- K951141STAR TECHNOLGIES, INC. IMAGE MANAGEMENT SERVER1Cleared 510(K)
- K942558INSTACINE1Cleared 510(K)
- K945654NICOM DIGITAL IMAGE MANAGER1Cleared 510(K)
- K933115DIGITAL DISK RECORDER1Cleared 510(K)
- K9354987500 DATA TOWER1Cleared 510(K)
- K931410NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM1Cleared 510(K)
- K934889OLYMPUS IMAGEMANAGER SYSTEM1Cleared 510(K)
- K934888OLYMPUS IMAGEMANAGERSYSTEM1Cleared 510(K)
- K926348SC1000 SCAN CONVERTER1Cleared 510(K)
- K923680ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM1Cleared 510(K)
- K921275SONY LASER VIDEODISC RECORDING SYSTEM1Cleared 510(K)
- K914728KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM1Cleared 510(K)
- K915094VORTECH'S IMAGE ARCHIVAL AND RETRIEVAL SYSTEM1Cleared 510(K)
- K905488DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN1Cleared 510(K)
- K903806ANGIOTEC IMAGE MANAGEMENT SYSTEM1Cleared 510(K)
- K901956DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)1Cleared 510(K)
- K901118OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM1Cleared 510(K)
- K891690KODAK EKTASCAN IMAGE MANAGER1Cleared 510(K)
- K885327PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM1Cleared 510(K)
- K891485ANGIOTEC FMX-2220 SYSTEM1Cleared 510(K)
- K884990IMS-3 PICTURE ARCHIVING SYSTEM1Cleared 510(K)
- K884148DISKCAM DC 60011Cleared 510(K)
- K882184HR-1000 W/SUFFIXES (B,C OR D)1Cleared 510(K)
- K873048KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET1Cleared 510(K)
- K863286ERS SYSTEM1Cleared 510(K)
- K862842ADVANCED NUCLEAR COMPUTER1Cleared 510(K)
- K844132MEDIVISION SERIES 5000 FLUOROSCOPIC DIGITAL IMAGER1Cleared 510(K)
- K843349ND3100 VIDEO IMAGER1Cleared 510(K)
- K833525CEMAX-10001Cleared 510(K)
- 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
TOMTECP90
- Page Type
- Cleared 510(K)
- 510(k) Number
- K950279
- 510(k) Type
- Traditional
- Applicant
- TOMTEC IMAGING SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/15/1995
- Days to Decision
- 234 days
- Submission Type
- Summary