Lower Limb AI (LLAI)— 510(k) K261641

Substantially Equivalent

AI Planning Logic, Inc.

FDA 510(k) clearance K261641 for Lower Limb AI (LLAI), Substantially Equivalent on 2026-08-18. Applicant: AI Planning Logic, Inc.. Device class: 2.

Clearance details

Applicant
AI Planning Logic, Inc.
Product code
Code QIH
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Rosa, CA, US
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