# PZO: Software For Visualization Of Vascular Anatomy And Intravascular Devices

- Device class: 2; regulation: 21 CFR 892.2050; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 148 days (middle half 126–178)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 1
- 2019: 1
- 2020: 1
- 2022: 2
- 2023: 2
- 2024: 1
- 2025: 2

## Most-cited predicates
- K202322: Sim&Size (2020), cited by 2
- K190049: Sim&Size (2019), cited by 2
- K171534: SurgicalPreview (2017), cited by 2
- K222664: Sim&Size (2023), cited by 1
- K242124: Sim&Size (2024), cited by 1
- K230006: Ankyras (2023), cited by 1
- K212373: Sim&Size (2022), cited by 1

Source page: https://510kreport.com/product-code/PZO
Data by year (CSV): https://510kreport.com/product-code/PZO.csv