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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 doppler, ultrasonic
510(k) Number K052894
Device Name SONOLINE G60 S ULTRASOUND SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
P O BOX 7393
MOUNTAIN VIEW,  CA  94039 -7393
Applicant Contact ISKRA MRAKOVIC
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
P O BOX 7393
MOUNTAIN VIEW,  CA  94039 -7393
Correspondent Contact ISKRA MRAKOVIC
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received10/14/2005
Decision Date 11/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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