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
- K111167XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT2Cleared 510(K)
- K093503INTRAX FILM PROCESSOR2Cleared 510(K)
- K091628OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX2Cleared 510(K)
- K024342RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP10002Cleared 510(K)
- K023801FILM PROCESSOR, MODEL LIFE RAY PRO 10002Cleared 510(K)
- K023825FILM PROCESSOR, MODEL LIFE RAY PRO 25002Cleared 510(K)
- K023613AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.0362Cleared 510(K)
- K022154LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D2Cleared 510(K)
- K002640FREEDOM AUTOMATIC FILM PROCESSOR2Cleared 510(K)
- K002404MICRO-MAX, MODEL 3192Cleared 510(K)
- K001321ALL-PRO 20102Cleared 510(K)
- K992818OPTIMAX/ COMPACT 22Cleared 510(K)
- K990969KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K991435AII-PRO 100 PLUS AND ALL-PRO 2002Cleared 510(K)
- K981280CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS2Cleared 510(K)
- K973125MAMMOLOADER BY C.M.A. SRL2Cleared 510(K)
- K970059KODAK MINILOADER(2000)2Cleared 510(K)
- K9627503M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR2Cleared 510(K)
- K955706JPI AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K951373FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ2Cleared 510(K)
- K954484KODAK AUTOMIXER II PLUS2Cleared 510(K)
- K954345DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K951397KODAK X-OMAT 5000 RA PROCESSOR2Cleared 510(K)
- K951396KODAK X-OMAT 3000 RA PROCESSOR2Cleared 510(K)
- K944046FUJI COMPUTED RADIOGRAPHY SYSTEMS2Cleared 510(K)
- K950043JPI AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K940112X-RAY FILM PROCESSOR2Cleared 510(K)
- K950358KONICA SRX-201 AUTOMATIC X-RA FILM PROCESSOR2Cleared 510(K)
- K940540VELO ACE2Cleared 510(K)
- K9405583M XP-2000 X-RAY FILM PROCESSOR2Cleared 510(K)
- K934350KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS2Cleared 510(K)
- K935957FUJI MEDICAL FILM PROCESSOR FPM28002Cleared 510(K)
- K931316KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K931315KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K931317KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K933001KODAK XML 300 DARKROOM FILM FEEDER2Cleared 510(K)
- K931314KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K931312KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K931313KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K931882MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K931883AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.0332Cleared 510(K)
- K933408FUJI DAYLIGHT CASSETTE MULTI-LOADER2Cleared 510(K)
- K925885AFP 17 X 4 AUTOMATIC FILM PROCESSOR2Cleared 510(K)
- K923554KODAK EKTASCAN2Cleared 510(K)
- K925569AX-700LE AUTOMATIC X-RAY FILM PROCESSOR2Cleared 510(K)
- K924552DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II)2Cleared 510(K)
- K924430AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.0272Cleared 510(K)
- K923552KODAK X-OMAT FS-1A PROCESSOR2Cleared 510(K)
- K921269KODAK X-OMAT MODEL 180 LP PROCESSOR2Cleared 510(K)
- K920715KODAK X-OMAT FIXER MANAGER2Cleared 510(K)
- K914143KODAK X-OMAT 480 RA PROCESSOR2Cleared 510(K)
- K913354KODAK EKTASCAN STORAGE PHOSPHOR READER MODEL 1A2Cleared 510(K)
- K9122253M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT2Cleared 510(K)
- K911291ALL-PRO 1002Cleared 510(K)
- K911714KODAK M35-MX-0MAT PROCESSOR2Cleared 510(K)
- K911713KODAK 100-J & 100-K CHEMICAL MIXERS2Cleared 510(K)
- K911711KODAK AUTOMATIC FILM FEEDER, MODEL RA2Cleared 510(K)
- K905607KODAK X-OMAT MULTILOADER 3002Cleared 510(K)
- K904238KODAK X-MAT 270 RA PROCESSOR2Cleared 510(K)
- K902732KODAK X-OMAT 460 RA PROCESSOR2Cleared 510(K)
- K901772KODAK M35A-M X-OMAT PROCESSOR2Cleared 510(K)
- K890486MXR-14 FILM PROCESSOR2Cleared 510(K)
- K885207KODAK MULTILOADER 7002Cleared 510(K)
- K882320KODAK EKTASCAN LASER PRINTER ADAPTER, MODEL M6/M82Cleared 510(K)
- K881248KODAK AUTOMATIC FILM FEEDER, MODEL 112Cleared 510(K)
- K8805653M TRIMATIC M MODULAR SYSTEM AND ACCESSORIES2Cleared 510(K)
- K8805633M XP515 X-RAY FILM PROCESSOR2Cleared 510(K)
- K8805643M XP 505 X-RAY FILM PROCESSOR2Cleared 510(K)
- K874908C900 X-RAY FILM PROCESSOR2Cleared 510(K)
- K874926KODAK REMOTE ALARM UNIT2Cleared 510(K)
- K862595KODAK M35A X-OMAT PROCESSOR2Cleared 510(K)
- K861225KODAK AUTOMIXER II2Cleared 510(K)
- K860666KODAK X-OMAT PROCESSOR, MODEL ME-32Cleared 510(K)
- K855219KODAK RP X-OMAT PROCESSOR MODEL M6B2Cleared 510(K)
- K854219KODAK M35 X-OMAT PROCESSOR2Cleared 510(K)
- K832603CURIX CAPACITY FILM CENTER2Cleared 510(K)
- K812088POLAROID RADIOGRAPHIC FILM PROCESSOR2Cleared 510(K)
- K801209KODAK MEDICAL X-RAY DEVELOPER & REPLEN.2Cleared 510(K)
- K790121FILM-X 902Cleared 510(K)
- K781934PROCESSOR, MODEL M82Cleared 510(K)
- K780248CRONEX QC-1 PROCESSOR2Cleared 510(K)
- K771857AUTOMIXER, KODAK2Cleared 510(K)
- K760905SUPERMAX AUTOMATIC X-RAY PROCESSOR2Cleared 510(K)
- 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
- 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
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K981280
- 510(k) Type
- Traditional
- Applicant
- BAYER CORP., AGFA DIV.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/30/1998
- Days to Decision
- 22 days
- Submission Type
- Summary