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FDA PRODUCT CODE · CLASS II

PZO — Software For Visualization Of Vascular Anatomy And Intravascular Devices

Visualization and measurement of blood vessels and intravascular devices for preoperational planning.

DEVICE CLASS
Class II
REGULATION
21 CFR 892.2050
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K253122Sim&Cure · 510k2025-12-23
K250160Mentice Spain S.L. · 510k2025-05-06
K242124Sim&Cure · 510k2024-12-14

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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