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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 K170521
Device Name TRINITY/3D PROSTATE SUITE
Applicant
Koelis
16, Chemin Du Vieux Chene
Meylan,  FR 38240
Applicant Contact Laetitia GERVAIS
Correspondent
Koelis
16, Chemin Du Vieux Chene
Meylan,  FR 38240
Correspondent Contact Laetitia GERVAIS
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   LLZ  
Date Received02/22/2017
Decision Date 05/30/2017
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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