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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collimator, Automatic, Radiographic
510(k) Number K072780
Device Name MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR
Applicant
Ralco S.R.L.
P.O. Box 7007
Deer Field,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Ralco S.R.L.
P.O. Box 7007
Deer Field,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number892.1610
Classification Product Code
IZW  
Date Received09/28/2007
Decision Date 11/26/2007
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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