Indications for Use
FlexView Diagnostic is a software application used for reference and diagnostic viewing and analysis of multi-modality medical imaging and non-imaging data (e.g., video information) with associated reports and information. FlexView Diagnostic enables qualified healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents ad data. FlexView Diagnostic allows qualified users to perform simple and complex image manipulations (including window/level, markups, 3D visualization) and measurements.
Not intended for primary diagnosis of mammographic images.
Not intended for diagnostic use on mobile devices.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Device Description
The FlexView Viewer is a zero footprint web-based medical imaging platform that supports DICOM images.
Key Features:
- Zero-footprint Web browser based
- Medical image upload, transfer and display of medical images between facilities
- Allows access to images for all participants in the healthcare process, including radiologists, technologists, physicians, nurses and other patient care practitioners
- Serves as an information and data management system for for DICOM and non-DICOM medical images
- Contains functionality to view and annotate images
- Contains industry-standard tools for image manipulation, annotation and measurements
- Advanced image manipulation functions like view synchronization across series, 3D visualization like MIP and MPR
- Advanced image processing filters like histogram equalization (CLAHE) filter to aid in visualization of pathological features in the images
- Encrypted transmission of medical images through secured networks
- HIPAA-compliant data management, including centralized storage of user activities via audit trails
Intended User and User Training
FlexView Diagnostic is intended to be used by diagnostic or non-diagnostic clinicians to view and manipulate medical images.
The complete review of the FlexView user manual is required prior to using the system.
Intended Patient Population
FlexView is intended by use on patients who have had non-mammography medical images taken.
Contraindications
FlexView Diagnostic is not intended for primary diagnosis of mammographic images.
FlexView Diagnostic is not intended for diagnostic use on mobile devices.
Warnings and Precautions
The following warnings apply to the use of the FlexView Diagnostic system:
- CAUTION: FlexView Diagnostic is not intended for primary diagnosis of mammographic images.
- Do not use the FlexView Diagnostic software for diagnostic use on mobile devices.
- Do not use the FlexView Diagnostic software without review of this user manual first.
- Users should regularly confirm that the FlexView Diagnostic software has been updated with the latest security patches.