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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 K260844
Device Name ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
Applicant
Siemens Medical Solutions USA, Inc.
22010 S. E. 51st St.
Issaquah,  WA  98029
Applicant Contact Shilpa Rapaka
Correspondent
Siemens Medical Solutions USA, Inc.
22010 S. E. 51st St.
Issaquah,  WA  98029
Correspondent Contact Shilpa Rapaka
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ   OIJ   QIH  
Date Received03/16/2026
Decision Date 06/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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