K261641
- 510(k) number
- K261641
- Device name
- Lower Limb AI (LLAI)
- Applicant
- AI Planning Logic, Inc. CA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-08-18
- Date received
- 2026-05-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K261641.pdf
Official FDA record: K261641
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.