LVivo Software Application

The LVivo Software Application is a Class II medical device designed for the non-invasive processing of ultrasound images to detect, measure, and calculate medical parameters and provide quality score feedback in adult patients. Its science relies on image processing algorithms, validated through comprehensive non-clinical and clinical evaluations to demonstrate safety, effectiveness, and substantial equivalence to existing devices.

A communication to DiA Imaging Analysis Ltd., specifically through George Hattub, confirms that the LVivo Software Application has undergone review and been deemed substantially equivalent for its intended uses. This software is classified as a Class II medical image management and processing system, identified by product code QIH and regulated under 21 CFR 892.2050, with its determination issued on March 17, 2025. The marketing of the LVivo Software Application is subject to general controls and potential additional regulations, including requirements for annual registration, device listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration. The LVivo platform is a software system designed for the non-invasive processing of ultrasound images, enabling the detection, measurement, and calculation of relevant medical parameters related to structure and function in patients aged 18 and older, also providing quality score feedback. Comprehensive non-clinical and clinical performance evaluations were conducted, confirming the device's safety, effectiveness, and its substantial equivalence to a previously available device.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific medical parameters can the LVivo Software Application detect, measure, and calculate from ultrasound images?; How does the LVivo platform provide quality score feedback, and what are the clinical implications of this feature for image interpretation?; What were the methodologies and results of the non-clinical and clinical performance evaluations that confirmed the device's safety and effectiveness?; Which previously available device was the LVivo Software Application found substantially equivalent to, and what are the key differences or improvements?; Are there plans to expand the age indication for the LVivo Software Application beyond patients aged 18 and older?