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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K250959
Device Name BioticsAI
Applicant
Bioticsai, Inc.
1280 Anjou Pkwy.
Brentwood,  CA  94513
Applicant Contact Salman Khan
Correspondent
Innolitics, LLC
1101 W. 34th St. #550
Austin,  TX  78705
Correspondent Contact Meri Martinez
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
IYO   QIH  
Date Received03/31/2025
Decision Date 12/22/2025
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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