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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 K241211
Device Name CoLumbo
Applicant
Smart Soft Healthcare
113 Gen. Kolev str, suite 7.2
Varna,  BG 9002
Applicant Contact Nedelcho Georgiev
Correspondent
Smart Soft Healthcare
113 Gen. Kolev str, suite 7.2
Varna,  BG 9002
Correspondent Contact Nedelcho Georgiev
Regulation Number892.2050
Classification Product Code
QIH  
Date Received04/30/2024
Decision Date 08/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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