K250524
- 510(k) number
- K250524
- Device name
- Mendaera Guidance System
- Applicant
- Mendaera, Inc. CA · US
- Product code
- ITX — Transducer, Ultrasonic, Diagnostic
- Decision date
- 2025-07-02
- Date received
- 2025-02-21
- 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: K250524.pdf
Official FDA record: K250524
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.