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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 K261677
Device Name Artificial Intelligence Renal Assessment (AIRA) Version 1
Applicant
Aramis Global AI Consultancies, LLC
Rahet Albal Business Centre
Ct. Tower Bldg., Office #39
Dubai,  AE
Applicant Contact Anil Prahladan
Correspondent
John Delucia Consulting
34 Laurel Rd.
Guilford,  CT  06437
Correspondent Contact John DeLucia
Regulation Number892.2050
Classification Product Code
QIH  
Date Received05/21/2026
Decision Date 09/15/2026
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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