Follicle Clarity is a cloud-based software application package (Software as a Medical Device, SaMD). It is designed to view and quantify image data acquired on compatible diagnostic ultrasound systems. The software functions as an aid to interpreting clinicians by calculating the number and size of hypoechoic structures (ovarian follicles) in a transvaginal ultrasound volume sweep of the ovaries.
"An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and ""version"" or ""upgrade"" number."
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