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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K203509
Device Name SMART FINDER
Applicant
Ims Giotto S.P.A.
Via Sagittario, 5
Sasso Marconi,  IT 40037
Applicant Contact Antonella Rossi
Correspondent
THEMA S.r.l.
Via Saragat,5
Imola,  IT 40026
Correspondent Contact Marisa Testa
Regulation Number892.1710
Classification Product Code
IZH  
Date Received11/30/2020
Decision Date 07/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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