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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
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