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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, Tomography, Computed
510(k) Number K142222
Device Name NewTom 5G
Applicant
Qr S.R.L.
Via Silverstrini 20
Verona,  IT
Applicant Contact Lorenzo Bortolotti
Correspondent
THEMA S.r.l.
Via G. Saragat N.5
Imola,  IT
Correspondent Contact Testa Marisa
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/13/2014
Decision Date 01/26/2015
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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