K250160
- 510(k) number
- K250160
- Device name
- ANKYRAS
- Applicant
- Mentice Spain S.L. ES
- Product code
- PZO — Software For Visualization Of Vascular Anatomy And I
- Decision date
- 2025-05-06
- Date received
- 2025-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250160.pdf
Official FDA record: K250160
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.