K260161
- 510(k) number
- K260161
- Device name
- SmartGuide Disposable Guides and Grids
- Applicant
- UC-CARE , Ltd. IL
- Product code
- ITX — Transducer, Ultrasonic, Diagnostic
- Decision date
- 2026-07-30
- Date received
- 2026-01-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K260161.pdf
Official FDA record: K260161
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.