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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 K254015
Device Name CoLumbo C-Spine
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 Received12/15/2025
Decision Date 04/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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