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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 echo, ultrasonic
510(k) Number K081121
Device Name MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
1230 SHOREBIRD WAY
MOUNTAIN VIEW,  CA  94043
Applicant Contact MARTINA VOGT
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
1230 SHOREBIRD WAY
MOUNTAIN VIEW,  CA  94043
Correspondent Contact MARTINA VOGT
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received04/21/2008
Decision Date 06/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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