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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 K242838
Device Name QuickRad
Applicant
Aikenist Technologies Pvt, Ltd.
15/A, 2nd Floor, 10th Main, 22nd Cross
3rd Block, Jayanagar
Bengaluru,  IN 560011
Applicant Contact Ashwin Amarapuram Chandramouly
Correspondent
David Dills
5450 Ariva Way
#302
Lakeland,  FL  33812
Correspondent Contact David Dills
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/19/2024
Decision Date 02/21/2025
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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