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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K160442
Device Name Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers
Applicant
Neural Analytics, Inc.
2127 Sawtelle Blvd.
Los Angeles,  CA  90025
Applicant Contact JAY YONEMOTO
Correspondent
Neural Analytics, Inc.
2440 S. Sepulveda Blvd., Suite 115
Los Angeles,  CA  90064
Correspondent Contact JAVAD SEYEDZADEH
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
ITX  
Date Received02/17/2016
Decision Date 10/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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