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The Tracker / August 2026 / K261641

510(k) cleared

Lower Limb AI (LLAI)

AI Planning Logic, Inc. · Aug 18, 2026 · K261641

FDA cleared the Lower Limb AI (LLAI) from AI Planning Logic, Inc. on Aug 18, 2026 under K261641, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 18, 2026. The decision came 92 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for AI Planning Logic, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261641?

K261641 is the FDA 510(k) for Lower Limb AI (LLAI), submitted by AI Planning Logic, Inc.. FDA's decision date was Aug 18, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Lower Limb AI (LLAI)?

AI Planning Logic, Inc., based in Santa Rosa, CA, is the applicant of record for K261641.

How long did the K261641 review take?

FDA received the submission on May 18, 2026 and issued its decision on Aug 18, 2026, 92 days later.

← All decisions in August 2026