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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 Echo, Ultrasonic
510(k) Number K172256
Device Name SoftVue
Applicant
Delphinus Medical Technologies
45525 Grand River Ave.
Novi,  MI  48374
Applicant Contact Francis X. Dobscha
Correspondent
Delphinus Medical Technologies
45525 Grand River Ave.
Novi,  MI  48374
Correspondent Contact Jillian M. Reed
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received07/26/2017
Decision Date 03/02/2018
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
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