510(k) K160442

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers by Neural Analytics, Inc. — Product Code IYN

K160442 is an FDA 510(k) premarket notification submitted by Neural Analytics, Inc. for the device "Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers". The FDA issued a decision of Substantially Equivalent on Oct 21, 2016. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Neural Analytics, Inc. has 1 other 510(k) clearance on record.