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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 K232617
Device Name ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
Applicant
Siemens Medical Solutions, USA, Inc
22010 South East 51st Street
Issaquah,  WA  98029
Applicant Contact Shilpa Rapaka
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   OIJ  
Date Received08/28/2023
Decision Date 09/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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