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
- K2510223D-SHAPER2Cleared 510(K)
- K242295BunkerHill BMD2Cleared 510(K)
- K243218TBS iNsight (V4)2Cleared 510(K)
- K220402VirtuOst2Cleared 510(K)
- K2208223D-SHAPER2Cleared 510(K)
- K213760ABMD Software2Cleared 510(K)
- K191112GEHC DXA Bone Densitometers with enCORE version 182Cleared 510(K)
- K180782Aria2Cleared 510(K)
- K161682GE Lunar DXA Bone Densitometers with enCORE version 172Cleared 510(K)
- K152299TBS iNsight2Cleared 510(K)
- K140342QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT2Cleared 510(K)
- K133664ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS2Cleared 510(K)
- K130277SINGLE ENERGY (SE) FEMUR EXAMS2Cleared 510(K)
- K121716TBS INSIGHT2Cleared 510(K)
- K113725VIRTUOST2Cleared 510(K)
- K113616ACCUDXA22Cleared 510(K)
- K113286ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS2Cleared 510(K)
- K113356HOLOGIC VISCERAL FAT SOFTWARE2Cleared 510(K)
- K103730GE LUNAR VISCERAL FAT SOFTWARE2Cleared 510(K)
- K103265NHANES WHOLE BODY DXA REFERENCE DATABASE2Cleared 510(K)
- K091325TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS2Cleared 510(K)
- K072664GE LUNAR FEMUR STRENGTH SOFTWARE2Cleared 510(K)
- K082402OSDX HIP BMD SYSTEM2Cleared 510(K)
- K082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION2Cleared 510(K)
- K0807111.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION2Cleared 510(K)
- K072847APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS2Cleared 510(K)
- K072439GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT2Cleared 510(K)
- K071570GE LUNAR BODY COMPOSITION SOFTWARE2Cleared 510(K)
- K061561HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS2Cleared 510(K)
- K060111IVA (MXA II SOFTWARE OPTION)2Cleared 510(K)
- K052581LUNAR IDXA2Cleared 510(K)
- K042480INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS2Cleared 510(K)
- K041266PEDIATRIC REFERENCE DATABASE2Cleared 510(K)
- K033550DXL CALSCAN2Cleared 510(K)
- K033224HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER2Cleared 510(K)
- K031991DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS2Cleared 510(K)
- K030962DPX SERIES BRAVO DUO BONE DENSITOMETER2Cleared 510(K)
- K030330CTXA HIP EXTENDED REFERENCE DATA2Cleared 510(K)
- K023554DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE2Cleared 510(K)
- K023398HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY2Cleared 510(K)
- K021527SECTRA OSTEOPOROSIS PACKAGE2Cleared 510(K)
- K021331DEXACARE G42Cleared 510(K)
- K002113CTXA HIP; CTXA; QCT PRO CTXA HIP2Cleared 510(K)
- K011917ADVANCED HIP ASSESSMENT SOFTWARE2Cleared 510(K)
- K003656X-POSURE SYSTEM VERSION 2 MAMMO2Cleared 510(K)
- K002500X-POSURE SYSTEM VERSION 2 RAD2Cleared 510(K)
- K002711HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER2Cleared 510(K)
- K001812PEDIATRIC REFERENCE DATA2Cleared 510(K)
- K001756LUNAR REPORT GENERATOR II2Cleared 510(K)
- K993176MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY2Cleared 510(K)
- K001429MODIFICATION TO ACCUDEXA BONE DENSITOMETER2Cleared 510(K)
- K993337APOLLO MULTI-RACIAL REFERENCE POPULATION2Cleared 510(K)
- K000162METRISCAN BONE DENSITY SYSTEM2Cleared 510(K)
- K000826PRODIGY LATERAL VIEW SOFTWARE2Cleared 510(K)
- K992125XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 462Cleared 510(K)
- K992775OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W2Cleared 510(K)
- K992677EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W2Cleared 510(K)
- K992246QCT BONE MINERAL ANALYSIS SOFTWARE2Cleared 510(K)
- K984285OSTEOGRAM BONE DENSITOMETER2Cleared 510(K)
- K984178PRONOSCO X-POSURE SYSTEM2Cleared 510(K)
- K983724ORCA-DX BONE DENSITOMETER2Cleared 510(K)
- K983564PRODIGY TOTAL BODY SOFTWARE2Cleared 510(K)
- K983269FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER2Cleared 510(K)
- K983262FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS2Cleared 510(K)
- K983271FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS2Cleared 510(K)
- K983028FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W2Cleared 510(K)
- K983273XCT 2000 L PQCT BONE DENSITOMETER2Cleared 510(K)
- K982267DPX-RX BONE DENSITOMETER2Cleared 510(K)
- K980569FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS2Cleared 510(K)
- K980289FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER2Cleared 510(K)
- K981124ACCUDEXA BONE DENSITOMETER2Cleared 510(K)
- K980125REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER2Cleared 510(K)
- K974437EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE2Cleared 510(K)
- K973459NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS2Cleared 510(K)
- K973104NORLAND MODEL PDEXA BONE DENSITOMETER2Cleared 510(K)
- K971735ACCUDEXA BONE DENSITOMETER2Cleared 510(K)
- K972517EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE2Cleared 510(K)
- K972882APOLLO2Cleared 510(K)
- K964562DTX-200 BONE DENSITOMETER2Cleared 510(K)
- K972053PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM2Cleared 510(K)
- K963789DTX-100 BONE DENSITOMETER2Cleared 510(K)
- K961787BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS2Cleared 510(K)
- K970224PIXI BONE DENSITOMETER2Cleared 510(K)
- K964307EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS2Cleared 510(K)
- K963363HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS2Cleared 510(K)
- K964263EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE2Cleared 510(K)
- K961007EXPERT SPINE MORPHOTIETRY REFERENCE2Cleared 510(K)
- K961011DTX-200 BONE DENSITOMETER2Cleared 510(K)
- K961944LUNAR REPORT GENERATOR2Cleared 510(K)
- K953032LUNAR DPX DENSITOMETER2Cleared 510(K)
- K941362BONE MINERAL DENSITOMETER2Cleared 510(K)
- K952060QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-50002Cleared 510(K)
- K950611EXPERT MORPHOMERTY SOFTWARD2Cleared 510(K)
- K941127QCT-BONE MINERAL ANALYSIS SOFTWARE2Cleared 510(K)
- K941126QCT-BONE MINERAL ANALYSIS PHANTOM2Cleared 510(K)
- K945526LUNAR EXPERT2Cleared 510(K)
- K931996MODEL PDEXA BONE DENSITOMETER2Cleared 510(K)
- K943505HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER2Cleared 510(K)
- K934040THE OSTEOREPORT2Cleared 510(K)
- K926019FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET2Cleared 510(K)
- K926300DTX-1002Cleared 510(K)
- K922286MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER2Cleared 510(K)
- K915535FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM2Cleared 510(K)
- K914404ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT2Cleared 510(K)
- K913321HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER2Cleared 510(K)
- K913078LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET2Cleared 510(K)
- K905291LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA2Cleared 510(K)
- K905753QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER2Cleared 510(K)
- K905691QDR-1000 AND WITH X-RAY BONE DENSITOMETER2Cleared 510(K)
- K901804NORLAND XR26 WHOLE BODY OPTION2Cleared 510(K)
- K904980DPX-L AND DPX-ALPHA, MODIFICATION2Cleared 510(K)
- K902959NORLAND XR26 LATERAL SPINE OPTION2Cleared 510(K)
- K894795HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER2Cleared 510(K)
- K901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.104152Cleared 510(K)
- K901857GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)2Cleared 510(K)
- K901848GADOLINIUM-153 BONE DENSITOMETER SOURCES2Cleared 510(K)
- K901854GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)2Cleared 510(K)
- K890121MODIFIED DPX BONE DENSITOMETER2Cleared 510(K)
- K896677PC/QCT QUANTITATIVE SOFTWARE2Cleared 510(K)
- K890999MODIFIED QDR-1000 X-RAY BONE DENSITOMETER2Cleared 510(K)
- K894854QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE2Cleared 510(K)
- K891582MODIFIED OSTEOANALYZER (# SPSHA110/220)2Cleared 510(K)
- K884625DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY2Cleared 510(K)
- K881383ND1100 BONE DENSITY SCANNER2Cleared 510(K)
- K881865NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER2Cleared 510(K)
- K880404CSI/QCT2Cleared 510(K)
- K883280HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED2Cleared 510(K)
- K883360HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM2Cleared 510(K)
- K873296DPX BONE DENSITOMETER2Cleared 510(K)
- K864299NOVO BMC-LAB 23, BONE DENSITOMETER2Cleared 510(K)
- K871446HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-12Cleared 510(K)
- K871553X-CALIBER MODEL 1000 BONE MINERAL ANALYZER2Cleared 510(K)
- K863618BONE MINERAL DENSITOMETRY OPTION B7918AA2Cleared 510(K)
- K861233DUAL PHOTON BONE DENSITOMETER2Cleared 510(K)
- K861515OSTEOPAK BMD (BONE MINERAL DENSITOMETER)2Cleared 510(K)
- K852510COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS2Cleared 510(K)
- K852509QCT-BONE MINERAL PHANTOM2Cleared 510(K)
- K844835ND2100 SPINE SCANNER2Cleared 510(K)
- K844766ND1100 BONE DENSITY SCANNER2Cleared 510(K)
- K843922OSTEON BONE MINERAL ANALYZER2Cleared 510(K)
- K841463BONE DENSITOMETER2Cleared 510(K)
- K810159BONE MINERAL ANALYZER CONTROLLER2Cleared 510(K)
- K810140DUAL-PHOTON TOTAL BODY BONE MINERAL ANA2Cleared 510(K)
- K802180WISCONSIN DUAL-PHOTON BONE ANALYZER2Cleared 510(K)
- K802181WISCONSIN BONE MINERAL ANALYZER2Cleared 510(K)
- K792444NORLAND MODEL 278 BONE DENSITOMETER2Cleared 510(K)
- 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
PC/QCT QUANTITATIVE SOFTWARE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K896677
- 510(k) Type
- Traditional
- Applicant
- THE INSTITUTE FOR RADIOLOGICAL IMAGE SCIENCES, INC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/23/1990
- Days to Decision
- 57 days