510(k) K231875

Vaginal Tactile Ultrasound Imager by Advanced Tactile Imaging, Inc. — Product Code HIR

K231875 is an FDA 510(k) premarket notification submitted by Advanced Tactile Imaging, Inc. for the device "Vaginal Tactile Ultrasound Imager". The FDA issued a decision of Substantially Equivalent on February 22, 2024. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Advanced Tactile Imaging, Inc. has at least 1 other 510(k) clearance on record.