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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 K071950
Device Name SYNGO TRUED
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
20 VALLEY STREAM PKWY.
MALVERN,  PA  19355
Applicant Contact JAMES KUHN
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/16/2007
Decision Date 07/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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