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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 K232641
Device Name Neorad Pacs (Neorad Pacs)
Applicant
Everrtech Software Pvt, Ltd.
A306 Western Edge Ii
Borivali E.
Mumbai,  IN 400066
Applicant Contact Josh Baker
Correspondent
Everrtech Software Pvt, Ltd.
A306 Western Edge Ii
Borivali E.
Mumbai,  IN 400066
Correspondent Contact Josh Baker
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/30/2023
Decision Date 04/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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