PZO
10 FDA 510(k) clearances · Product code
167 daysmedian time to decision
359 days90th percentile
10clearances measured
FDA profile
- Official device name
- Software For Visualization Of Vascular Anatomy And Intravascular Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Medical specialty
- Radiology
- FDA definition
- Visualization and measurement of blood vessels and intravascular devices for preoperational planning.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Sim&Size (K253122) | Sim&Cure | 2025-12-23 |
| ANKYRAS (K250160) | Mentice Spain S.L. | 2025-05-06 |
| Sim&Size (K242124) | Sim&Cure | 2024-12-14 |
| Ankyras (K230006) | Mentice Spain S.L. | 2023-12-28 |
| Sim&Size (K222664) | Sim&Cure | 2023-01-27 |
| AneuGuide (K213838) | ArteryFlow Technology Co., Ltd. | 2022-06-01 |
| Sim&Size (K212373) | Sim&Cure | 2022-01-27 |
| Sim&Size (K202322) | Sim&Cure | 2020-12-31 |
| Sim&Size (K190049) | Sim&Cure | 2019-09-17 |
| SurgicalPreview (K171534) | Endo Vantage, LLC | 2017-11-08 |
Track PZO automatically
Every clearance here is in the API, with alerts when new ones post.