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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 K193257
Device Name ACUSON Sequoia Diagnostic Ultrasound System
Applicant
Siemens Medical Solutions USA, Inc
685 East Middlefield Road
Mountain View,  CA  94043
Applicant Contact Sulgue Choi
Correspondent
Siemens Medical Solutions USA, Inc
685 East Middlefield Road
Mountain View,  CA  94043
Correspondent Contact Sulgue Choi
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/26/2019
Decision Date 01/31/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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