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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Tilting
510(k) Number K854486
Device Name TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE
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 Number892.1980
Classification Product Code
IXR  
Date Received11/07/1985
Decision Date 01/10/1986
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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