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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K261465
Device Name INDIRA CLOUD VIEWER
Applicant
INDIGO TECHNOLOGIES
Carrera 7 155 C 30 To E Of 3205 Ed N. Pt.
Bogota,  CO
Applicant Contact Andres Felipe Sanabria Diaz
Correspondent
INDIGO TECHNOLOGIES
Carrera 7 155 C 30 To E Of 3205 ED North Point
Bogota,  CO
Correspondent Contact Andres Felipe Sanabria Diaz
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/04/2026
Decision Date 07/06/2026
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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