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
- K954666MPH50, MPH65, AND MPH801Cleared 510(K)
- K953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR1Cleared 510(K)
- K953831N 800 HF1Cleared 510(K)
- K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G1Cleared 510(K)
- K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR1Cleared 510(K)
- K950883POLYDOROS SX 65 AND 801Cleared 510(K)
- K950694COMPACT-X1Cleared 510(K)
- K950291DIGITAL 625HF1Cleared 510(K)
- K950041SII 360 APR1Cleared 510(K)
- K950040SII 525 APR1Cleared 510(K)
- K945453UD 150L-R II1Cleared 510(K)
- K945452UD 150L-F1Cleared 510(K)
- K950037N 800 HF1Cleared 510(K)
- K945731HFQ HIGH FREQUENCY RADIOGRAPHIC AND FLUROSCOPIC GENERATORS1Cleared 510(K)
- K945668KXO-80G1Cleared 510(K)
- K942731SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR1Cleared 510(K)
- K944150MICRO X-65 HF1Cleared 510(K)
- K944149MICRO X-80 HF1Cleared 510(K)
- K944148MICRO X-30HF1Cleared 510(K)
- K944147MICRO X-50 HF1Cleared 510(K)
- K943652VASCULAR MP X-RAY GENERATOR1Cleared 510(K)
- K943504RSX-525HF1Cleared 510(K)
- K942778MODEL VPW2877F8, MAMMO 5 POWER SUPPLY1Cleared 510(K)
- K942100MODEL TM EP HIGH VOLTAGE GENERATOR1Cleared 510(K)
- K934686MOLYBDENUM/RHODIUM FILTERS1Cleared 510(K)
- K940227SCPU X-RAY GENERATOR1Cleared 510(K)
- K935068RADIOGRAPHIC GENERATOR HFQ-WHIS1Cleared 510(K)
- K934967SHIMADZU UD150L-R X-RAY HIGH VOLTAGE GENERATOR1Cleared 510(K)
- K933777CONCEPT ONE1Cleared 510(K)
- K933471SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G1Cleared 510(K)
- K933650PHILIPS XRG 90 X-RAY GENERATOR SYSTEM1Cleared 510(K)
- K933240POLYDOROS IS1Cleared 510(K)
- K931930POYDOROS LX1Cleared 510(K)
- K931998LCR GENERATOR1Cleared 510(K)
- K931049ADVANTX SYSTEM1Cleared 510(K)
- K930792RSX 30HF1Cleared 510(K)
- K926365MAGMA XHF-30, XHF-40, XHF-501Cleared 510(K)
- K920351PCX 650HF RADIOGRAPHIC X-RAY1Cleared 510(K)
- K920349PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR1Cleared 510(K)
- K925684OLYMP-X,X-RAY GENERATOR1Cleared 510(K)
- K924078POLYDOROS C1Cleared 510(K)
- K925844PHILIPS SUPER CP FAMILY1Cleared 510(K)
- K925105PHILIPS MEDIO CP FAMILY1Cleared 510(K)
- K923786POLYDOROS XS50 AND SX801Cleared 510(K)
- K921875X-RAY CONTROL AND HI-VOLTAGE GENERATOR1Cleared 510(K)
- K922814TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT1Cleared 510(K)
- K922165ATC725, ATC525, AND AP3001Cleared 510(K)
- K921951MPG 65-80-100 X-RAY GENERATOR AND CONTROL1Cleared 510(K)
- K921516P2900 X-RAY GENERATOR1Cleared 510(K)
- K920730X-RAY HIGH VOLTAGE GENERATOR ED 125L1Cleared 510(K)
- K915339GEN-X 800/3001Cleared 510(K)
- K915227GEN-X 800/5001Cleared 510(K)
- K913222OPTIMA1Cleared 510(K)
- K914266MICRO-X 30 HF1Cleared 510(K)
- K914236MICRO-X 50 HF1Cleared 510(K)
- K913577MILESTONE MS 325 RADIOGRAPHIC X-RAY GENERATOR1Cleared 510(K)
- K913578MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR1Cleared 510(K)
- K914301GEN-X 800/8001Cleared 510(K)
- K914302GEN-X 800/6501Cleared 510(K)
- K911562EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR1Cleared 510(K)
- K913234VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY1Cleared 510(K)
- K913065SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L1Cleared 510(K)
- K913064SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L1Cleared 510(K)
- K913062SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-101Cleared 510(K)
- K913063SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-101Cleared 510(K)
- K912449MICRO-X 15 HF1Cleared 510(K)
- K911280SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150B1Cleared 510(K)
- K910650SELECTOR MD (50KW AND 80 KW)1Cleared 510(K)
- K911339SHIMADZU X-RAY HIGH-VOLTAGE GENERATOR XUD150K1Cleared 510(K)
- K910020CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS1Cleared 510(K)
- K910820VPW 2877E6 X-RAY POWER SUPPLY1Cleared 510(K)
- K905695MICRO-X 80HF1Cleared 510(K)
- K905799HFQ SERIES CONTROLS AND GENERATORS1Cleared 510(K)
- K904169VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY1Cleared 510(K)
- K905855VPW2877E7 X RAY POWER SUPPLY1Cleared 510(K)
- K902986G.E. DXD 325/350/350II/DXD 525/525II GENERATORS1Cleared 510(K)
- K904114ANATECH X-RAY GENERATOR1Cleared 510(K)
- K902987G.E. DXS 350/550/650/650II SINGLE PHASE GENERATORS1Cleared 510(K)
- K902985G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN1Cleared 510(K)
- K902988G.E. MSI 850/850II/1250 THREE PHASE GENERATORS1Cleared 510(K)
- K904043KXO-80C/80D1Cleared 510(K)
- K904397TEC 14101Cleared 510(K)
- K903942SHIMADZU X-RAY HIGH VOLTAGE GENERATPR AHD150G1Cleared 510(K)
- K902106VPW 2877D5, X-RAY POWER SUPPLY1Cleared 510(K)
- K902637FUTURUS 2001 X-RAY GENERATOR1Cleared 510(K)
- K901951MODEL# MPC1Cleared 510(K)
- K900062U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL1Cleared 510(K)
- K895969RADKOR DXG-650R1Cleared 510(K)
- K89447930KW HIGH FREQ. RADIO. GENE. MODELS HFQ-30/HFQ30SE1Cleared 510(K)
- K893681MAMM-AIRE CP1Cleared 510(K)
- K893674RME 325R1Cleared 510(K)
- K892657SENSIMAT1Cleared 510(K)
- K892943MULTI PULSE POWER UNIT GENERATOR1Cleared 510(K)
- K890083GX-2000 STATIONARY X-RAY GENERATOR1Cleared 510(K)
- K890066STAR 361Cleared 510(K)
- K884678ESP 3-PHASE X-RAY GENERATORS1Cleared 510(K)
- K883976CFX 6251Cleared 510(K)
- K884134MICRO-X 100CP1Cleared 510(K)
- K883431RAYMAX 2100 MODELS 2130 & 21361Cleared 510(K)
- K883154SELDIX 325 TWO PULSE GENERATOR/CONTROL1Cleared 510(K)
- K883081RADKOR, XG-5151Cleared 510(K)
- K881696RADKOR XG-3251Cleared 510(K)
- K8805253 PHASE HIGH FREQ. DIAG. X-RAY GEN. MICRO-X 60HF1Cleared 510(K)
- K881886MODIFIED X-RAY CONTROLS, MODEL ED125L AND ED150L1Cleared 510(K)
- K881387X-RAY GENERATING SYSTEM, TF 8001Cleared 510(K)
- K881386X-RAY GENERATING SYSTEM TF 10001Cleared 510(K)
- K881795SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150K1Cleared 510(K)
- K880524THREE PHASE DIAGNOSTIC X-RAY GENERATOR MICRO-X 1001Cleared 510(K)
- K880519SINGLE PHASE DIAG. X-RAY GENERATOR MICRO-X 6501Cleared 510(K)
- K880521SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX-6501Cleared 510(K)
- K880522THREE PHASE, DIAGNOSTIC X-RAY GENERATOR MICRO-X 801Cleared 510(K)
- K880523THREE PHASE, DIAGNOSTIC GENERATOR MICRO-X 751Cleared 510(K)
- K880532SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 3501Cleared 510(K)
- K874946SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-601Cleared 510(K)
- K880050EDEC 60R1Cleared 510(K)
- K875341EDEC 60 R/F1Cleared 510(K)
- K875342EDEC 90C1Cleared 510(K)
- K873544MPG-50 X-RAY GENERATOR1Cleared 510(K)
- K872445POWER-AID INDEPENDENT X-RAY POWER SOURCE1Cleared 510(K)
- K864624PROBE, UPTAKE, NUCLEAR1Cleared 510(K)
- K872357TRANSWORLD 360V, MODEL A1-40401Cleared 510(K)
- K871145EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR1Cleared 510(K)
- K870851EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR1Cleared 510(K)
- K864339PORTA RAY MODEL 3251Cleared 510(K)
- K862800SMX GENERATOR1Cleared 510(K)
- K862682MVP GENERATOR, CATALOG NO. H80181Cleared 510(K)
- K854499GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR1Cleared 510(K)
- K860736FISCHER IMAGING FX325R X-RAY GENERATOR1Cleared 510(K)
- K860203TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR1Cleared 510(K)
- K852908EDEC 20001Cleared 510(K)
- K851011HOFMANN G-S60 SINGLE PHASE X-RAY GENERATOR1Cleared 510(K)
- K850823SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR1Cleared 510(K)
- K850117XMA 325 (X-RAY GENERATOR)1Cleared 510(K)
- K843443EDEC-1001Cleared 510(K)
- K842348SPX GENERATOR1Cleared 510(K)
- K833846PROCESS 100 ST1Cleared 510(K)
- K820593ESP SERIES (X-RAY GENERATORS1Cleared 510(K)
- K820307TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE1Cleared 510(K)
- K820112SIEMENS POLYDOROS 8001Cleared 510(K)
- K813051COMPTAR III1Cleared 510(K)
- K812616POLYPHOS 5001Cleared 510(K)
- K811198ECCO GENERATOR1Cleared 510(K)
- K802996VECTOR-100 X-RAY GENERATOR1Cleared 510(K)
- K802941CINESCOPE III RADIOGRAPHIC GENERATOR1Cleared 510(K)
- K802548GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX801Cleared 510(K)
- K802550GENERATOR, HIGH VOLT, X-RAY, MPX 1251Cleared 510(K)
- K802549GENERATOR, HIGH VOLT, X-RAY, MPX 1001Cleared 510(K)
- K802551GENERATOR, HIGH VOLT, X-RAY, MPX100/1251Cleared 510(K)
- K801808BR 2002 X-RAY GENERATOR SYSTEM1Cleared 510(K)
- K801408CINESCOPE III1Cleared 510(K)
- K792392POLYPHOS1Cleared 510(K)
- K792393GIGANTOS 1012 MP1Cleared 510(K)
- K791933CONVERSION CONTRACTOR TIMER KIT1Cleared 510(K)
- K791214TRIDOROS 7121Cleared 510(K)
- K780742INTRAORAL DENTAL X-RAY GENERATOR1Cleared 510(K)
- K771294X-RAY GENERATOR MODEL KXO-151Cleared 510(K)
- K771295X-RAY GENERATOR MODEL KX0-8251Cleared 510(K)
- K770338X-RAY CONTROL & X-RAY HV GENERATOR1Cleared 510(K)
- K770006MPX 801Cleared 510(K)
- K770008MPX 1251Cleared 510(K)
- K770007MPX 1001Cleared 510(K)
- K760569THREE PHASE X-RAY CONTROLS & HV GENERATORS1Cleared 510(K)
- K760568SINGLE PHASE X-RAY CONTROLS & HV GENERATORS1Cleared 510(K)
- 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
ATC725, ATC525, AND AP300
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K922165
- 510(k) Type
- Traditional
- Applicant
- GENDEX CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/27/1992
- Days to Decision
- 80 days
- Submission Type
- Statement