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
- K000412VISION R/F TILTING TABLE2Cleared 510(K)
- K973039LEGACY/LEGACY-D TABLE2Cleared 510(K)
- K971128CAP-35B III/CINE 2752Cleared 510(K)
- K970640PHILIPS EASY DIAGNOST2Cleared 510(K)
- K965105ELECTROPHYSIOLOGY TILT TABLE MODEL #96602Cleared 510(K)
- K965096FLUOROVIEW SERIES FLUOROSCOPIC TABLES2Cleared 510(K)
- K963851TILTING RADIOGRAPHIC TABLE (REMOTE)2Cleared 510(K)
- K961022TANGENT VI TABLE2Cleared 510(K)
- K954356COMPAX 90/15E2Cleared 510(K)
- K953556VACS TABLE, 96502Cleared 510(K)
- K953556VACS TABLE, 96502Cleared 510(K)
- K951176KOORDINAT M2Cleared 510(K)
- K950981ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-6502Cleared 510(K)
- K950402CORSINI 90902Cleared 510(K)
- K945842MOBILIX MOBILE X-RAY TABLE2Cleared 510(K)
- K943581HYDRADJUST IV UROLOGICAL TABLE2Cleared 510(K)
- K944987URO - ELITE TABLE ACCESSORIES2Cleared 510(K)
- K935444OCTOSTOP(R) CHAIR (NEW MODEL2Cleared 510(K)
- K940721CLINIX VP 4 TABLE2Cleared 510(K)
- K934574MODEL MPFT-01, GENESIS2Cleared 510(K)
- K931563SPECTRUM MARK I SPECIAL PROCEDURES TABLE2Cleared 510(K)
- K924326ARTHRODYN 45 DEGREE X-RAY TABLE2Cleared 510(K)
- K925175SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-200 30/902Cleared 510(K)
- K922591UROLOGICAL C-ARM TABLE, MODEL #056-4502Cleared 510(K)
- K922364DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST2Cleared 510(K)
- K920726UROLOGICAL X-RAY TABLE HS-10A2Cleared 510(K)
- K920728X-RAY DIAGNOSTIC TABLE YSF-1002Cleared 510(K)
- K920742HYDRAJUST IV UROLOGICAL TABLE2Cleared 510(K)
- K920722X-RAY DIAGNOSTIC TABLE YSF-200-30-902Cleared 510(K)
- K914417MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE2Cleared 510(K)
- K912996MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE2Cleared 510(K)
- K915853TANGENT V2Cleared 510(K)
- K914165X-RAY TABLE2Cleared 510(K)
- K912741ELITE R 90/152Cleared 510(K)
- K913147SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-1002Cleared 510(K)
- K910838TREATMENT TABLE2Cleared 510(K)
- K912586TANGENT IV2Cleared 510(K)
- K911098PHILIPS URO DIAGNOST MRF2Cleared 510(K)
- K911267RADIOGRAPHIC/FLUOROSCOPIC TABLE MODEL 90042Cleared 510(K)
- K905265620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB2Cleared 510(K)
- K905501ELITE 50002Cleared 510(K)
- K905153REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-1102Cleared 510(K)
- K905152REMOTE CONTROLLED X-RAY DIAG. RSZ-2002Cleared 510(K)
- K901654MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE2Cleared 510(K)
- K902989G.E. MONITROL 90 AND G.E. MONITROL 152Cleared 510(K)
- K903422MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE2Cleared 510(K)
- K903395UROMAT 20002Cleared 510(K)
- K896583F.A.S.T. TABLE2Cleared 510(K)
- K896119RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE2Cleared 510(K)
- K896324ELITE 1500 RADIOGRAPHIC TILTING TABLE2Cleared 510(K)
- K893673RMS 1802Cleared 510(K)
- K892226TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLE2Cleared 510(K)
- K884531BETA 90/50 MOBILE IMAGING TABLE2Cleared 510(K)
- K883863GENESIS 1802Cleared 510(K)
- K883162TELESTATIX X-RAY TABLE2Cleared 510(K)
- K883153UNDISTAT WITH EXPLORATOR 35 (UCS 35E)2Cleared 510(K)
- K882019SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE2Cleared 510(K)
- K880529CEILING MOUNTED TILTING TABLE TANGENT III2Cleared 510(K)
- K874113OMNI DIAGNOST2Cleared 510(K)
- K874114TRAUMA TABLE II2Cleared 510(K)
- K870707PENTAMAX 1 MODEL B TABLE SYSTEM2Cleared 510(K)
- K854478REI-90/90 RADIOGRAPHIC TABLE2Cleared 510(K)
- K860913SIREGRAPH D2Cleared 510(K)
- K854486TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE2Cleared 510(K)
- K854085OMNI PLANE SYSTEM2Cleared 510(K)
- K853175REI-90/152Cleared 510(K)
- K850948TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER2Cleared 510(K)
- K843926PRESTILIX 16902Cleared 510(K)
- K840227UROLIX-3 UROLOGICAL TABLE2Cleared 510(K)
- K840226MOTOR TILTED EXAM. TABLE UV-562Cleared 510(K)
- K792645TRIOSKOP2Cleared 510(K)
- K792326HILO TRANS-X TRAUMA TRANSPORT2Cleared 510(K)
- K791812SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM2Cleared 510(K)
- K781532UROSKOP A AND B2Cleared 510(K)
- K771293X-RAY DIAG. TABLE DT-KCS2Cleared 510(K)
- K770334TILTING X-RAY TABLE2Cleared 510(K)
- K760466TABLE, X-RAY, RFX CLASSICAL2Cleared 510(K)
- 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
UNDISTAT WITH EXPLORATOR 35 (UCS 35E)
- Page Type
- Cleared 510(K)
- 510(k) Number
- K883153
- 510(k) Type
- Traditional
- Applicant
- BAY X-RAY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/6/1988
- Days to Decision
- 42 days