FDA Product Code PZO: Software For Visualization Of Vascular Anatomy And Intravascular Devices
Visualization And Measurement Of Blood Vessels And Intravascular Devices For Preoperational Planning.
Leading manufacturers include Sim&Cure, Mentice Spain S.L. and ArteryFlow Technology Co., Ltd..
FDA 510(k) Cleared Software For Visualization Of Vascular Anatomy And Intravascular Devices Devices (Product Code PZO)
About Product Code PZO - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code PZO since 2017, with 10 receiving FDA clearance (average review time: 176 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
Recent submissions under PZO have taken an average of 114 days to reach a decision - down from 202 days historically, suggesting improved FDA processing for this classification.
PZO devices are reviewed by the Neurology panel. Browse all Neurology devices →