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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 K233610
Device Name ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System
Applicant
Siemens Medical Solutions USA, Inc.
22010 SE 51st St.
Issaquah,  WA  98029
Applicant Contact Shilpa Rapaka
Correspondent
Siemens Medical Solutions USA, Inc.
22010 SE 51st St.
Issaquah,  WA  98029
Correspondent Contact Shilpa Rapaka
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OBJ   OIJ  
Date Received11/13/2023
Decision Date 06/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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