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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 K232500
Device Name Lumify Diagnostic Ultrasound System
Applicant
Philips Ultrasound
22100 Bothell Everett Hwy
Bothell,  WA  98021 -8431
Applicant Contact Sudipta Chakrabarti
Correspondent
Philips Ultrasound
22100 Bothell Everett Hwy
Bothell,  WA  98021 -8431
Correspondent Contact Sudipta Chakrabarti
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received08/17/2023
Decision Date 10/26/2023
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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