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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K241659
Device Name Ultrasound Workspace (UWS 6.0)
Applicant
Philips Ultrasound, LLC
22100 Bothell Everett Hwy
Bothell,  WA  98021
Applicant Contact Petra Galgoczy
Correspondent
Philips Ultrasound, LLC
22100 Bothell Everett Hwy
Bothell,  WA  98021
Correspondent Contact Petra Galgoczy
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Codes
IYN   LLZ  
Date Received06/10/2024
Decision Date 02/10/2025
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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