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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 K251106
Device Name Sonosite LX and Sonosite PX Ultrasound Systems
Applicant
Fujifilm Sonosite, Inc.
21919, 30th Dr. SE
Bothell,  WA  98012
Applicant Contact Anoush Frankian
Correspondent
Fujifilm Sonosite, Inc.
21919, 30th Dr. SE
Bothell,  WA  98012
Correspondent Contact Anoush Frankian
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received04/11/2025
Decision Date 08/29/2025
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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