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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 K142395
Device Name SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
685 East Middlefield Road
Mountain View,  CA  94043
Applicant Contact Shelly Pearce
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN   OBJ  
Date Received08/27/2014
Decision Date 09/09/2014
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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