E-Scopics - FDA 510(k) Cleared Devices

E-Scopics, is a medical device company specializing in software-based Radiology imaging systems. The company operates with a manufacturing facility in Aix-En-Provence, France. E-Scopics develops dematerialized ultrasound platforms that transform standard consumer devices into diagnostic imaging tools through proprietary software and ultra-low power digital transducers.

The company has received 3 FDA 510(k) clearances from 3 total submissions, with all submissions focused on Radiology devices. E-Scopics achieved its first FDA 510(k) clearance in 2022 and most recently in 2026, demonstrating sustained regulatory activity and ongoing product innovation.

The company's clinical focus includes active surveillance of chronic conditions such as metabolic, inflammatory, pulmonary, and cardiovascular diseases. Hepatoscope®, E-Scopics' flagship product, is an FDA-cleared and CE-marked diagnostic ultrasound system designed for point-of-care liver assessment. The company also operates an OEM and research platform, licensing its software-based ultrasound technology to academic institutions and corporate partners.

For detailed information on specific device names, product codes, and individual clearance dates, consult the FDA 510(k) database.