Brief Device DescriptionIndications for UseContraindicationsPrerequisitesWarningsAdverse EffectsIntended UseIntended User PopulationIntended Patient PopulationCompatible Radiological Data SourcesHardware Requirements
System RequirementsInstallationRegistrationUpdatesAccessing the manual and viewing the product label
Description of How Second Opinion® OperatesGetting StartedLaunch ApplicationLogging OnSetting TabNavigating Patient RecordsFinding Specific ChartsTypical Image DisplayImage Selector FilmstripHow to Read ResultsHow to Use the Confidence SliderSelective Display of Potentials DetectionsHow to Use Image Adjustment ControlsEnd User Controls to Add or Remove DetectionsTooth Parts Segmentation Overlay & Labeling of Caries
About TroubleshootingProblem: Images or Results Fail to LoadUnable to Log InImages MissingApplication Crashes
Regulatory Compliance
SecondOpinion® complies with the regulatory requirements of the following:
● ENISO 13485:2016 entitled Medical Devices.
● Quality Management Systems Requirements for regulatory purposes, FDA 21 CFR Part 820 entitled Quality System Regulation (QSR).
● EUMedical Device Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Device (MDR)
● MedicalDevice Single Audit Program (MDSAP)
● Canadian Medical Devices Regulations SOR 98-282
● The Health Insurance Portability and Accountability Act (HIPAA)