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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 K252634
Device Name Imagine® Enterprise Suite
Applicant
Softlink International Private Limited
2 Anand Park
Aundh,  IN 411007
Applicant Contact Parkash S Kamat
Correspondent
I3cglobal Reghelps Pvt, Ltd.
Mr-02, D-4, First Floor, Clayworks Shankaraa, H&G
Shankaraa, Kanakapura Rd., Doddakallasandra
Bangalore,  IN 560062
Correspondent Contact Sakthileela Nagaiyan
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received08/20/2025
Decision Date 01/16/2026
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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