DeviceClearance

Product code PZO— Radiology

Sim&Size

Classification name
Software For Visualization Of Vascular Anatomy And Intravascular Devices
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Total cleared
10
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PZO under 21 CFR 892.2050, via openFDA

Market context for product code PZO

FDA has cleared 10 devices under product code PZO between 2017 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PZO

Recent clearances under product code PZO

Data sourced from openFDA. This site is unofficial and independent of the FDA.