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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 K010938
Device Name SYNGO MULTIMODALITY WORKSTATION
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Applicant Contact KATHLEEN RUTHERFORD
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 WOOD AVENUE SOUTH
ISELIN,  NJ  08830
Correspondent Contact KATHLEEN RUTHERFORD
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/29/2001
Decision Date 06/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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