Lower Limb AI (LLAI)— 510(k) K261641
Substantially EquivalentAI 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.
Summary
AI Planning Logic filed Lower Limb AI (LLAI) under product code QIH, automated radiological image processing software. The record has no description beyond the name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The applicant filed from Santa Rosa, California. The decision came 92 calendar days after receipt (May 18 to August 18, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- AI Planning Logic, Inc.
- Product code
- Product 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
Recent devices under product code QIH
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