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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 K213279
Device Name NovaGuide 2 Intelligent Ultrasound
Applicant
Novasignal Corporation
2440 S. Sepulveda Blvd., Suite 115
Los Angeles,  CA  90064
Applicant Contact Raajdeep (Raaj) Venkatesan
Correspondent
Novasignal Corporation
2440 S. Sepulveda Blvd., Suite 115
Los Angeles,  CA  90064
Correspondent Contact Carrene Plummer
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   OQQ  
Date Received10/01/2021
Decision Date 03/02/2022
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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