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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 K232145
Device Name ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System
Applicant
Siemens Medical Solutions USA, Inc.
22010 South East 51st Street
Issaquah,  WA  98029
Applicant Contact Sulgue Choi
Correspondent
Siemens Medical Solutions USA, Inc.
22010 South East 51st Street
Issaquah,  WA  98029
Correspondent Contact Sulgue Choi
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OIJ   QIH  
Date Received07/19/2023
Decision Date 10/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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