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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 K142517
Device Name SoftVue
Applicant
Delphinus Medical Technologies, Inc.
46701 Commerce Center Dr.
Plymouth,  MI  48170
Applicant Contact Andrea N Wallen-Gerding
Correspondent
Delphinus Medical Technologies, Inc.
46701 Commerce Center Dr.
Plymouth,  MI  48170
Correspondent Contact Andrea N Wallen-Gerding
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received09/08/2014
Decision Date 10/31/2014
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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