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
- 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
- K251934qXR-Detect2Cleared 510(K)
- K252934Diagnocat2Cleared 510(K)
- K253009DS Core Detect2Cleared 510(K)
- K252086DTX Studio Assist2Cleared 510(K)
- K250525Second Opinion® Panoramic2Cleared 510(K)
- K250264SugarBug (1.x)2Cleared 510(K)
- K251002Videa Dental AI2Cleared 510(K)
- K250753VELMENI for DENTISTS (V4D)2Cleared 510(K)
- K243234Second Opinion® CS2Cleared 510(K)
- K242437Smile Dx®2Cleared 510(K)
- K243893Second Opinion® Pediatric2Cleared 510(K)
- K243239Lung AI (LAI001)2Cleared 510(K)
- K242600Second Opinion Periapical Radiolucency Contours2Cleared 510(K)
- K243831Rayvolve LN2Cleared 510(K)
- K241725Better Diagnostics Caries Assist (BDCA) Version 1.02Cleared 510(K)
- K241620ChestView US2Cleared 510(K)
- K242522Second Opinion CC2Cleared 510(K)
- K240003Velmeni for Dentists (V4D)2Cleared 510(K)
- K233738Overjet Caries Assist-Pediatric2Cleared 510(K)
- K231805qXR-LN2Cleared 510(K)
- K232384Videa Dental Assist2Cleared 510(K)
- K230144Denti.AI Detect2Cleared 510(K)
- K231001DeepTek CXR Analyzer v1.02Cleared 510(K)
- K230085Lung-CAD2Cleared 510(K)
- K231678Overjet Periapical Radiolucency Assist2Cleared 510(K)
- K223811Lung-CAD2Cleared 510(K)
- K223133VisiRad XR2Cleared 510(K)
- K221921DTX Studio Clinic 3.02Cleared 510(K)
- K222746Overjet Caries Assist2Cleared 510(K)
- K220928Overjet Calculus Assist2Cleared 510(K)
- K213353Aorta-CAD2Cleared 510(K)
- K212519Overjet Caries Assist2Cleared 510(K)
- K213795Videa Caries Assist2Cleared 510(K)
- K210365Second Opinion2Cleared 510(K)
- K201560Auto Lung Nodule Detection2Cleared 510(K)
- K210666Chest-CAD2Cleared 510(K)
- P980025Logicon Caries Detection Software2PMA Approval
- P150043QVCAD System (Version 3.3)2PMA Approval
- P160009PowerLook® Tomo Detection Software2PMA Approval
- P100005M-VU ALGORITHM ENGINE2PMA Approval
- P150043QVCAD SYSTEM2PMA Approval
- P970058IMAGE CHECKER, IMAGE CHECKER LICENSE2PMA Approval
- P980025LOGICON CARIES DETECTOR2PMA Approval
- P120004PARASCRIPT (R) ACCUDETECT (R)2PMA Approval
- P100005M-VU ALGORITHM ENGINE2PMA Approval
- P980025LOGICON CARIES DETECTOR2PMA Approval
- P100005M-VU ALGORITHM ENGINE2PMA Approval
- P970058IMAGE CHECKER CAD2PMA Approval
- P100005M-VU ALGORITHM ENGINE2PMA Approval
- P120004PARASCRIPT ACCUDETECT 6.1.02PMA Approval
- P100005M-VU ALGORITHM ENGINE2PMA Approval
- P010038SECONDLOOK DIGITAL2PMA Approval
- P010038SECONDLOOK DIGITAL V7.2 CAD2PMA Approval
- P100005M-VU ALGOIRITHM ENGINE2PMA Approval
- P970058IMAGECHECKER CAD2PMA Approval
- P000041CLEAREAD DETECT2PMA Approval
- P100007BREAST COMPANION SOFTWARE SYSTEM2PMA Approval
- P100005M-VU ALGORITHM ENGINE2PMA Approval
- P000041CLEARREAD DETECT2PMA Approval
- P010038SECONDLOOK (SL) CAD2PMA Approval
- P000041ONGUARD2PMA Approval
- P010038SECONDLOOK (SL) CAD2PMA Approval
- P010038SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM2PMA Approval
- P000041ONGUARD2PMA Approval
- P010038SECONDLOOK2PMA Approval
- P030007KODAK MAMMOGRAPHY CAD ENGINE2PMA Approval
- P970058IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY2PMA Approval
- P980025LOGICON CARIES DETECTOR2PMA Approval
- P000041RAPIDSCREEN RS-2000D2PMA Approval
- P000041RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL2PMA Approval
- P970058IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY2PMA Approval
- P010038SECOND LOOK2PMA Approval
- P030007MAMMOGRAPHY CAD ENGINE2PMA Approval
- P010038SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM2PMA Approval
- P970058IMAGECHECKER M5000, IMAGECHECKER M5000 DM, IMAGECHECKER M5000LX, IMAGECHECKER M5000 M5000 DX VERSION 8.02PMA Approval
- P970058IMAGECHECKER D2PMA Approval
- P030007KODAK MAMMOGRAPHY CAD ENGINE2PMA Approval
- P010038SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM2PMA Approval
- P010038ICAD SYSTEM2PMA Approval
- P010038ICAD SYSTEM2PMA Approval
- P970058IMAGECHECKER M5000D AND M5000DM, (SOFTWARE VERSION 5.2)2PMA Approval
- P970058IMAGECHECKER D, DM, AND OEM-D (SOFTWARE VERSION 5.1)2PMA Approval
- P970058IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)2PMA Approval
- P010038ICAD SYSTEM2PMA Approval
- P010034SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY2PMA Approval
- P010038ICAD SYSTEM2PMA Approval
- P010034SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY2PMA Approval
- P970058IMAGE CHECKER M1000 SYSTEM2PMA Approval
- P010034SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY2PMA Approval
- P000041RAPIDSCREEN RS-2000D2PMA Approval
- P000041RAPIDSCREEN RS-2000D2PMA Approval
- P010034SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY2PMA Approval
- P010038ICAD2PMA Approval
- P970058IMAGECHECKER2PMA Approval
- P010038ICAD2PMA Approval
- P010038ICAD2PMA Approval
- P970058IMAGECHECKER M1000 SYSTEM2PMA Approval
- P010034SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY2PMA Approval
- P970058IMAGE CHECKER M1000 SYSTEM2PMA Approval
- P970058IMAGECHECKER M10002PMA Approval
- P010034SECOND LOOK (TM)2PMA Approval
- P010038SECOND LOOK2PMA Approval
- P970058IMAGE CHECKER (CAD) SYSTEM, M1002PMA Approval
- P000041RAPIDSCREEN RS-20002PMA Approval
- P970058IMAGE CHECKER (CAD) SYSTEM, M10002PMA Approval
- P970058PROMINENT CALC FEATURE MARKER2PMA Approval
- P970058IMAGE CHECKER M1000 SYSTEM2PMA Approval
- P970058IMAGECHECKER M1000 SYSTEM2PMA Approval
- P970058IMAGECHECKER M1000 SYSTEM2PMA Approval
- P970058IMAGE CHECKER M10002PMA Approval
- P970058THE IMAGECHECKER SYSTEM2PMA Approval
- P970058IMAGE CHECKER2PMA Approval
- P970058IMAGECHECKER M1000 SYSTEM2PMA Approval
- P970058IMAGECHECKER M1000 PROCESSOR WITH V1.3 RELEASE2PMA Approval
- P980025LOGICON CARIES DETECTOR2PMA Approval
- P970058M1000 IMAGECHECKER2PMA Approval
- 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
BREAST COMPANION SOFTWARE SYSTEM
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- ALMEN LABORATORIES, INC.
- Trade Name
- BREAST COMPANION SOFTWARE SYSTEM
- Generic Name
- Analyzer, medical image
- Decision Date
- 2/10/2012
- Days to Decision
- 723 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval