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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K051745
Device Name ECHOSYSTEM
Applicant
Medstrat, Inc.
1901 Butterfield Rd.
Suite 600
Downers Grove,  IL  60515
Applicant Contact ROBERT J BISHOP
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact SILVIA ANKOVA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/29/2005
Decision Date 07/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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