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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K182086
Device Name ARCO FP
A.T.S. Applicazione Tecnologie Speciali s.r.l.
Via A. Volta, n.10
Torre de’ Roveri,  IT 24060
Applicant Contact Duilio Finazzi
Thema s.r.l.
Via Saragat 5
Imola,  IT 40026
Correspondent Contact Marisa Testa
Regulation Number892.1650
Classification Product Code
Subsequent Product Code
Date Received08/02/2018
Decision Date 08/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No