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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 K250367
Device Name CoLumboX
Applicant
Smart Soft Healthcare AD
113 General Kolev St. , Primorski District., Office 7.2
Varna,  BG 9002
Applicant Contact Nedelcho Georgiev
Correspondent
Smart Soft Healthcare AD
113 General Kolev St. , Primorski District., Office 7.2
Varna,  BG 9002
Correspondent Contact Yoana Ivanova
Regulation Number892.2050
Classification Product Code
QIH  
Date Received02/10/2025
Decision Date 05/28/2025
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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