PZO

Software For Visualization Of Vascular Anatomy And Intravascular Devices

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2025-12-23.

NumberDecision dateApplicantDevice nameSummary
K2531222025-12-23Sim&CureSim&SizePDF
K2501602025-05-06Mentice Spain S.L.ANKYRASPDF
K2421242024-12-14Sim&CureSim&SizeFDA
K2300062023-12-28Mentice Spain S.L.AnkyrasPDF

3 summaries are archived here for direct download.

Official FDA classification page: PZO
Classification and pathway per current FDA publications. Data from openFDA (CC0).