• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K192388
Device Name SonoVision Ultrasound Imaging System
Tissue Differentiation Intelligence, LLC
234 NE 4th Avenue
Delray Beach,  FL  33483
Applicant Contact Christian Zaal
Qserve Group, US, Inc.
303 Twin Dolphin, Suite 600
Redwood Shores,  CA  94065
Correspondent Contact Lorry Weaver Huffman
Regulation Number892.1550
Classification Product Code
Subsequent Product Codes
Date Received09/03/2019
Decision Date 03/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No