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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 K261641
Device Name Lower Limb AI (LLAI)
Applicant
AI Planning Logic, Inc.
1617 Ronne Dr.
Santa Rosa,  CA  95404
Applicant Contact Philippe Ballaire
Correspondent
Sagemar Medical, LLC
30628 Detroit Rd.
#254
Westlake,  OH  44145
Correspondent Contact Jennifer Palinchik
Regulation Number892.2050
Classification Product Code
QIH  
Date Received05/18/2026
Decision Date 08/18/2026
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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