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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Beam Limiting, X-Ray, Diagnostic
510(k) Number K946320
Device Name R 302
Applicant
Ralco S.R.L.
Via Volturno, 29
20035 Lissone Mi
Italy,  IT 20035
Applicant Contact VINCENZO VELARDII
Correspondent
Ralco S.R.L.
Via Volturno, 29
20035 Lissone Mi
Italy,  IT 20035
Correspondent Contact VINCENZO VELARDII
Regulation Number892.1610
Classification Product Code
KPW  
Date Received12/28/1994
Decision Date 05/11/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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