PZO
- Product code
- PZO
- Device name
- Software For Visualization Of Vascular Anatomy And Intravascular Devices
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.2050
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 10 (all years; only the last 3 years are listed here)
FDA classification definition
Visualization and measurement of blood vessels and intravascular devices for preoperational planning.
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253122 | 2025-12-23 | Sim&Cure | Sim&Size | |
| K250160 | 2025-05-06 | Mentice Spain S.L. | ANKYRAS | |
| K242124 | 2024-12-14 | Sim&Cure | Sim&Size | FDA |
| K230006 | 2023-12-28 | Mentice Spain S.L. | Ankyras |
Official FDA classification page: PZO
Classification and pathway per current FDA publications. Data from openFDA (CC0).