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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full Field Digital, System, X-Ray, Mammographic
510(k) Number K200424
Device Name Giotto Class (Models - 3000X-YY and 4000X-YY)
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 Number892.1715
Classification Product Code
MUE  
Date Received02/20/2020
Decision Date 06/18/2020
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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