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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
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