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
- K141454SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD2Cleared 510(K)
- K141346SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD2Cleared 510(K)
- K111566DRYVIEW CHROMA IMAGING SYSTEM2Cleared 510(K)
- K092280CYPHER DICOM PRINT SOLUTION2Cleared 510(K)
- K090469CARESTREAM DRYVIEW 5850 LASER IMAGER2Cleared 510(K)
- K083522SONY UP-DF750 DIGITAL FILM IMAGER2Cleared 510(K)
- K081637LASER IMAGER DRYPRO MODEL 8732Cleared 510(K)
- K072680DRYSTAR AXYS, MODEL EYZ4E2Cleared 510(K)
- K061999DRY LASER IMAGER, DRYPRO MODEL 8322Cleared 510(K)
- K061302DIGITAL PRINTER P6000D SERIES, MODEL P6000DU2Cleared 510(K)
- K060440CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER2Cleared 510(K)
- K052251DRYSTAR MODEL 55002Cleared 510(K)
- K042133DRY LASER IMAGER, MODEL DRYPRO MODEL 7932Cleared 510(K)
- K042232NP-2600 SERIES HARDCOPY PRINTERS2Cleared 510(K)
- K042159KODAK COLOR MEDICAL IMAGER 10002Cleared 510(K)
- K042158KODAK MEDICAL IMAGER 3002Cleared 510(K)
- K033821KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY2Cleared 510(K)
- K033377FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L2Cleared 510(K)
- K032681KONICA LASER IMAGER, MODEL DRYPRO MODEL 7712Cleared 510(K)
- K032635DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 53002Cleared 510(K)
- K030690CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS2Cleared 510(K)
- K024188UP-DF500 FILMSTATION DIGITAL FILM IMAGER2Cleared 510(K)
- K023287DRYSTAR 55002Cleared 510(K)
- K022658LR DICOM CONTROLLER2Cleared 510(K)
- K021054CODONICS HORIZON CI MEDICAL MULTIMEDIA DRY IMAGER; CODONICS HORIZON GS MEDICAL MULTIMEDIA GREY SCALE DRY IMAGER2Cleared 510(K)
- K013052KONICA LASER IMAGER, DRYPRO MODEL 751/7522Cleared 510(K)
- K012941DRYSTAR, MODEL 4500M2Cleared 510(K)
- K012010MODIFICATION TO LR 5200 FILM RECORDER2Cleared 510(K)
- K011949ELK LASER IMAGER, MODEL EL-DRY 40002Cleared 510(K)
- K011617LIFEJET PRINTER 4002Cleared 510(K)
- K010275DRYSTAR 4500 PRINTER, MODEL 45002Cleared 510(K)
- K003481CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 16602Cleared 510(K)
- K002146KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY2Cleared 510(K)
- K992586KONICA LASER IMAGER, DRYPRO MODEL 7222Cleared 510(K)
- K991282COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES2Cleared 510(K)
- K983905KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 36002Cleared 510(K)
- K972822IMATION SE-204 LASER IMAGER2Cleared 510(K)
- K972660RAVEN DRY PRINTER2Cleared 510(K)
- K973422LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])2Cleared 510(K)
- K973028HELIOS LASER IMAGER 14172Cleared 510(K)
- K972847KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)2Cleared 510(K)
- K971760COLORPOINT OR PROFESSIONAL COLORPOINT2Cleared 510(K)
- K972163IMATION SE-196 LASER IMAGER2Cleared 510(K)
- K964414LR 5200 LASER FILM RECORDER2Cleared 510(K)
- K962364CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)2Cleared 510(K)
- K962967FUJI MEDICAL DRY IMAGER FM-DP 26362Cleared 510(K)
- K962051ASPECT OPTICAM2Cleared 510(K)
- K953165ULTRA COMPACT VIDEO IMAGER2Cleared 510(K)
- K955394SIENET TELERADIOLOGY PRODUCT LINE2Cleared 510(K)
- K954149ASPECT DIGITAL FORMATTER2Cleared 510(K)
- K953477MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING2Cleared 510(K)
- K953475CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING2Cleared 510(K)
- K954198VOXCAM2Cleared 510(K)
- K951948KODAK XLS 8600 (PS)2Cleared 510(K)
- K951807KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER2Cleared 510(K)
- K950359KONICA LASER IMAGER LI-212Cleared 510(K)
- K950721FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L2Cleared 510(K)
- K950423MINI IMAGER2Cleared 510(K)
- K950610FIKO FO;, TJER,A; O,AGER FTO-10002Cleared 510(K)
- K950288AUTOLASER MULTI FORMAT CAMERA2Cleared 510(K)
- K945475FUJI MEDICAL LASER IMAGER FL-IM D2Cleared 510(K)
- K9361523M 1152 LASER IMAGER2Cleared 510(K)
- K9361423M 1154 LASER IMAGER2Cleared 510(K)
- K940332MODEL FORTY ULTRA COMPACT VIDEO IMAGER2Cleared 510(K)
- K930755ULTRA COMPACT VIDEO IMAGER2Cleared 510(K)
- K925650IMAGEVIEW 50002Cleared 510(K)
- K925265IMAGEVIEW 460002Cleared 510(K)
- K925220PMI100 VIDEO IMAGER2Cleared 510(K)
- K923481PHILIPS LASER DISK ARCHIVE2Cleared 510(K)
- K925289MATRIX CR 2050, PMI 30002Cleared 510(K)
- K921215LASERSTAR IMAGER2Cleared 510(K)
- K923536NUCLEAR MEDICINE LASER IMAGER2Cleared 510(K)
- K921906HARRIS MODEL 20002Cleared 510(K)
- K921381MEDGRAPHIX INTL VR 1000 SERIES2Cleared 510(K)
- K9232223M COLOR LASER IMAGER, MODEL 9792Cleared 510(K)
- K9230753M LASER IMAGER MODEL 9692Cleared 510(K)
- K922411KODAK EKTASCAN, XLT7720, XLT7700, PCD 20002Cleared 510(K)
- K921992MP3000 SERIES III VIDEO IMAGER2Cleared 510(K)
- K921743KODAK EKTASCAN 2180 LASER PRINTER2Cleared 510(K)
- K920769KONICA LI 10 AND 10A LASER IMAGER2Cleared 510(K)
- K914834VORTECH 3M NETWORK PRINTING2Cleared 510(K)
- K914582KODAK EKTASCAN 1120 LASER PRINTER2Cleared 510(K)
- K912799EAGLE SYSTEM2Cleared 510(K)
- K912073POLAROID HELIOS LASER IMAGER2Cleared 510(K)
- K911437KODAK EKTASCAN CABLE EXTENSION2Cleared 510(K)
- K9100923M LASER IMAGER XL2Cleared 510(K)
- K902347COMPACT LASER IMAGER, MODEL CLI-1002Cleared 510(K)
- K905566KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS2Cleared 510(K)
- K904897MODEL 400 ULTRA COMPACT VIDEO IMAGER2Cleared 510(K)
- K904363MULTI FORMAT VIDEO IMAGER 600 PLUS2Cleared 510(K)
- K903238AFGA VIDEO IMAGER, VARIOUS MODELS2Cleared 510(K)
- K900900MP3000 SERIES II COMPACT VIDEO IMAGER2Cleared 510(K)
- K900899MP3000 COMPACT VIDEO IMAGER2Cleared 510(K)
- K9008966000 PLUS MULTI-FORMAT VIDEO IMAGER2Cleared 510(K)
- K900901MP4000 SERIES II COMPACT VIDEO IMAGER2Cleared 510(K)
- K9008989000 ECONOMICAL 14 X 17 VIDEO IMAGER2Cleared 510(K)
- K9008975000/5000C MULTI-FORMAT CAMERAS FOR NUCLEAR MEDI.2Cleared 510(K)
- K900885FUJI MEDICAL LASER IMAGER2Cleared 510(K)
- K896683COMPACT VIDEO IMAGER MP4000 SERIES III2Cleared 510(K)
- K895668DIGICAM LHP (VIDEO INTERFACE OPTION)2Cleared 510(K)
- K891924SCOPIX LASER IMAGER2Cleared 510(K)
- K883324DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)2Cleared 510(K)
- K890097KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 10002Cleared 510(K)
- K885127SIS 2000 MAMMOGRAPHIC X-RAY SYSTEM2Cleared 510(K)
- K882096SCOPIX VIDEO IMAGER2Cleared 510(K)
- K882483FTI 200 MEDICAL THERMAL IMAGER2Cleared 510(K)
- K871957SPACEMISER 8-10 FILM RECORDER2Cleared 510(K)
- K871959FRANTZ IMAGING COMPACT CAMERA2Cleared 510(K)
- K871958SPACEMISER 8-17 FILM RECORDER2Cleared 510(K)
- K871778DIGISPOT IMAGER2Cleared 510(K)
- K863629KODAK EKTASCAN LASER PRINTER, MODEL 1002Cleared 510(K)
- K863856S-RAY CAMERA2Cleared 510(K)
- K862416FTI 100 MEDICAL THERMAL IMAGER2Cleared 510(K)
- K860776MATRIX LR, LR 22A & LR/LASER RECORDER2Cleared 510(K)
- K860761MULTI-IMAGE CAMERA, SERIES 2100, MODEL #2100-062Cleared 510(K)
- K860691KODAK EKTASCAN VIDEO CAMERA & COMPACT VIDEO CAMERA2Cleared 510(K)
- K8550433M DRY SILVER IMAGER2Cleared 510(K)
- K850184MEDICAL MULTI-IMAGE CAMERA-6762Cleared 510(K)
- K8435023M LASER IMAGER2Cleared 510(K)
- K843582MULTI-FORMAT FILM CAMERA2Cleared 510(K)
- K840385VIDEO PRINT2Cleared 510(K)
- 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
HELIOS LASER IMAGER 1417
- Page Type
- Cleared 510(K)
- 510(k) Number
- K973028
- 510(k) Type
- Traditional
- Applicant
- STERLING DIAGNOSTIC IMAGING, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/28/1997
- Days to Decision
- 75 days
- Submission Type
- Summary