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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 K253111
Device Name Aeka Imaging
Applicant
Good Methods Global, Inc.
2954
Mallory Cir. Suite 20
Celebration,  FL  34747
Applicant Contact Arjun Satheesh
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
LLZ  
Date Received09/24/2025
Decision Date 03/13/2026
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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