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
- K081557PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER2Cleared 510(K)
- K053173DS CASSETTE2Cleared 510(K)
- K040378KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 84182532Cleared 510(K)
- K023020AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE2Cleared 510(K)
- K021903KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE2Cleared 510(K)
- K013686KODAK DIRECTVIEW TABLETOP CASSETTE2Cleared 510(K)
- K013229LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE2Cleared 510(K)
- K012373LIFERAY WL CASSETTE, LIFERAY KW CASSETTE2Cleared 510(K)
- K983918RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)2Cleared 510(K)
- K980722TRIMAX RADIOGRAPHIC CASSETTE2Cleared 510(K)
- K963914CM & CM DS-72Cleared 510(K)
- K971431UMI X-RAY FILM CASSETTE2Cleared 510(K)
- K970090SOLO-SLED2Cleared 510(K)
- K961453KODAK MN-R 2000 CASSETTE2Cleared 510(K)
- K962336RADIOGRAPHIC FILM CASSETTES2Cleared 510(K)
- K953724CRONEX RADIATION THERAPY CASSETTE2Cleared 510(K)
- K953725CRONEX RADIATION THERAPY VERIFICATION CASSETTE2Cleared 510(K)
- K953444MCI OPTONIX ECONOMY CASSETTE2Cleared 510(K)
- K952891CRONEX LOW ABSORPTION CASSETTE2Cleared 510(K)
- K951006KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)2Cleared 510(K)
- K945858X-RAY FILM CASSETTE2Cleared 510(K)
- K945328JPI X-RAY FILM CASSETTE2Cleared 510(K)
- K945039MCI OPTONIX CASSETTE OKAMOTO CASSETE2Cleared 510(K)
- K941600MT-300 CASSETTE HOLDER2Cleared 510(K)
- K942481FUJI ULTIMA EC-MA CASSETTE2Cleared 510(K)
- K941475CRONEX REGULAR CASSETTE2Cleared 510(K)
- K941518DUPONT CRONEX PORTABLE GRID CASSETTE2Cleared 510(K)
- K935397NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS2Cleared 510(K)
- K932565FUJIFILM EC-B SERIES CASETTE2Cleared 510(K)
- K931074DU PONT MV DARKROOM CASSETTE2Cleared 510(K)
- K930220CASSETTE, RADIOGRAPHIC FILM2Cleared 510(K)
- K930244JPI X-RAY FILM CASSETTE2Cleared 510(K)
- K923334MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER2Cleared 510(K)
- K921826KODAK INSIGHT PORTABLE IMAGING SYSTEM2Cleared 510(K)
- K911041INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE2Cleared 510(K)
- K896708PERLINK CASSETTE, KIRAN CASSETTE2Cleared 510(K)
- K901013RADIOGRAPHIC FILM CASSETTE2Cleared 510(K)
- K900620DU PONT MAMMOGRAPHY CASSETTE2Cleared 510(K)
- K895335CRONEX COMPACT MAMMOGRAPHY CASSETTE2Cleared 510(K)
- K893728PINK CASSETTE CADDIE2Cleared 510(K)
- K890750KODAK X-OMATIC RA CASSETTE2Cleared 510(K)
- K890361KODAK MIN-R 2 CASSETTE2Cleared 510(K)
- K885178KODAFLEX II RADIATION THERAPY L CASSETTE2Cleared 510(K)
- K883312L-F/KODAK FLEXIBLE GRID CASSETTE2Cleared 510(K)
- K875083KODAK KODAFLEX II CASSETTE2Cleared 510(K)
- K860754KODAK T-MAT M FILM SO-2452Cleared 510(K)
- K850415CRONEX KEVLAR CASSETTE2Cleared 510(K)
- K843176KODAK X-OMATIC RADIATION THERAPY CASS2Cleared 510(K)
- K812535PLASTILIX MINIRAD D CASSETTE2Cleared 510(K)
- K792721HUESTIS FLEXI-HOLDER2Cleared 510(K)
- K771682MIN-R CASSETTE2Cleared 510(K)
- 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
- 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
SOLO-SLED
- Page Type
- Cleared 510(K)
- 510(k) Number
- K970090
- 510(k) Type
- Traditional
- Applicant
- SOLO-SLED, LLC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/21/1997
- Days to Decision
- 101 days
- Submission Type
- Summary