PZO — Software For Visualization Of Vascular Anatomy And Intravascular Devices Class II
FDA product code PZO covers "Software For Visualization Of Vascular Anatomy And Intravascular Devices", a Class II medical device regulated under 21 CFR 892.2050. Submissions are reviewed by the Radiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PZO
- Device Class
- Class II
- Regulation Number
- 892.2050
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Radiology
- Implant
- No
Definition
Visualization and measurement of blood vessels and intravascular devices for preoperational planning.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253122 | sim and cure | Sim&Size | December 23, 2025 |
| K250160 | mentice spain s.l | ANKYRAS | May 6, 2025 |
| K242124 | sim and cure | Sim&Size | December 14, 2024 |
| K230006 | mentice spain s.l | Ankyras | December 28, 2023 |
| K222664 | sim and cure | Sim&Size | January 27, 2023 |
| K213838 | arteryflow technology co | AneuGuide | June 1, 2022 |
| K212373 | sim and cure | Sim&Size | January 27, 2022 |
| K202322 | sim and cure | Sim&Size | December 31, 2020 |
| K190049 | sim and cure | Sim&Size | September 17, 2019 |
| K171534 | endo vantage | SurgicalPreview | November 8, 2017 |