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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K934311
Device Name INTRASCAN(R) MINI-PACS
Applicant
Markcare Medical Systems, Inc.
87 Rte. 17 N.
Maywood,  NJ  07607
Applicant Contact JOHN A REILLING
Correspondent
Markcare Medical Systems, Inc.
87 Rte. 17 N.
Maywood,  NJ  07607
Correspondent Contact JOHN A REILLING
Regulation Number892.1560
Classification Product Code
IYO  
Date Received09/01/1993
Decision Date 12/13/1993
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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