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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K885327
Device Name PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM
Applicant
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Applicant Contact ROBERT T JOSSICK
Correspondent
Philips Medical Systems North America, Inc.
710 Bridgeport Ave.
Shelton,  CT  06484
Correspondent Contact ROBERT T JOSSICK
Regulation Number892.2010
Classification Product Code
LMB  
Date Received12/28/1988
Decision Date 05/11/1989
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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