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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 K030487
Device Name R 72
Applicant
Ralco S.R.L.
333 Milford Rd.
Deerfield,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Ralco S.R.L.
333 Milford Rd.
Deerfield,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number892.1610
Classification Product Code
KPW  
Date Received02/14/2003
Decision Date 08/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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