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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, Fluoroscopic, Image-Intensified
510(k) Number K961690
Device Name CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105
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 Number892.1650
Classification Product Code
JAA  
Date Received05/01/1996
Decision Date 06/27/1996
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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