510(k) clearance

Lower Limb AI (LLAI)

FDA 510(k) source

510(k) number

K261641

Applicant

AI Planning Logic, Inc.

Decision date

Aug 18, 2026

Date received

May 18, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QIH

Device type

Automated Radiological Image Processing Software

Device class

Class II

Regulation

21 CFR 892.2050

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Santa Rosa, CA, US