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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 K101749
Device Name SYNGO TRUED SOFTWARE
Applicant
SIEMENS MEDICAL SOLUTIONS
20 VALLEY STREAM PARKWAY
MALVERN,  PA  19355
Applicant Contact JAMES E KUHN
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/22/2010
Decision Date 08/16/2010
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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