K230006
- 510(k) number
- K230006
- Device name
- Ankyras
- Applicant
- Mentice Spain S.L. ES
- Product code
- PZO — Software For Visualization Of Vascular Anatomy And I
- Decision date
- 2023-12-28
- Date received
- 2023-01-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K230006.pdf
Official FDA record: K230006
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.