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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, Tomographic
510(k) Number K213081
Device Name CLISIS SYSTEMS, Discovery RF180
Applicant
General Medical Merate S.P.A
Via Partigiani, 25
Seriate,  IT 24068
Applicant Contact Luca Bianchessi
Correspondent
THEMA S.r.l.
Via Saragat,5
Imola,  IT 40026
Correspondent Contact Marisa Testa
Regulation Number892.1740
Classification Product Code
IZF  
Subsequent Product Codes
IZI   JAA   KXJ   MQB  
Date Received09/23/2021
Decision Date 10/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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