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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 K220497
Device Name CoLumbo
Smart Soft Healthcare AD
113 General Kolev Str.
Primorski Distr., Office 7.2
Varna,  BG 9002
Applicant Contact Yoana Ivanova
LightSource Research LLC
2108 N St., Suite N
Sacramento,  CA  95816
Correspondent Contact Yu Zhao
Regulation Number892.2050
Classification Product Code
Date Received02/22/2022
Decision Date 06/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No