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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomographic
510(k) Number K950571
Device Name LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270
Applicant
Continental X-Ray Corp.
2000 S. 25th Ave.
Broadview,  IL  60153
Applicant Contact OSCAR KHUTORYANSKY
Correspondent
Continental X-Ray Corp.
2000 S. 25th Ave.
Broadview,  IL  60153
Correspondent Contact OSCAR KHUTORYANSKY
Regulation Number892.1740
Classification Product Code
IZF  
Date Received01/31/1995
Decision Date 03/31/1995
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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