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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Tube Housing, X-Ray, Diagnostic
510(k) Number K864042
Device Name MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH
Applicant
Absolute X-Ray Corp.
23-06 31 Ave.
Long Island City,  NY  11106
Applicant Contact GEORGE S PAVEL
Correspondent
Absolute X-Ray Corp.
23-06 31 Ave.
Long Island City,  NY  11106
Correspondent Contact GEORGE S PAVEL
Regulation Number892.1760
Classification Product Code
ITY  
Date Received10/16/1986
Decision Date 10/27/1986
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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