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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, Angiographic
510(k) Number K924708
Device Name CINENET CARDIAC IMAGE NETWORK
Applicant
Sony Medical Systems
Cynthia A. Sinclair
45 W. St., Suite 2
Attleboro,  MA  02703
Applicant Contact C/O MDCI
Correspondent
Sony Medical Systems
Cynthia A. Sinclair
45 W. St., Suite 2
Attleboro,  MA  02703
Correspondent Contact C/O MDCI
Regulation Number892.1600
Classification Product Code
IZI  
Date Received09/18/1992
Decision Date 12/30/1992
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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