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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 K232285
Device Name U-Lite PRO
Applicant
Sonoscanner Sarl
6, Rue Andre Voguet
Ivry Sur Seine,  FR 94200
Applicant Contact Vincent Lux
Correspondent
Smith Associates
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact Yolanda Smith
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/31/2023
Decision Date 01/11/2024
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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