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# FDA Clears Signostics 510(k) for Mobile Urological Scans
- URL: https://www.fdaweb.com/fda-clears-signostics-510-k-for-mobile-urological-scans/
- Published: 2016-05-06T12:00:00.000Z
- Updated: 2026-09-14T21:00:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135592

FDA has cleared a Signostics 510(k) for Uscan, which the company describes as the first smart mobile-connected ultrasound visualization device targeted at urologic care. “Using algorithms from the science of computer vision, Uscan actively recognizes the 3D contours of the bladder, for far more accurate volume measurements than the industry standard, even on obese and other hard-to-scan patients,” it says. The device acquires up to 256 bladder slices – 32 times more than conventional bladder scanners, and it provides real-time ultrasound imaging of the kidneys, pelvic floor, prostate, gallbladder, bladder stones, and catheter emplacement, Signostics adds. Uscan is compatible with Android operating systems, and has built-in WiFi and Bluetooth connectivity for image management and interoperability with electronic health record systems.