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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 K960998
Device Name XRE COLLIMATOR
Applicant
Xre Corp.
300 Foster St.
Littleton,  MA  01460
Applicant Contact WAYNE V LOOMER
Correspondent
Xre Corp.
300 Foster St.
Littleton,  MA  01460
Correspondent Contact WAYNE V LOOMER
Regulation Number892.1610
Classification Product Code
IZW  
Date Received03/12/1996
Decision Date 04/03/1996
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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