510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PZOClass II

Software For Visualization Of Vascular Anatomy And Intravascular Devices

21 CFR 892.2050 / Radiology
FDA source (opens on fda.gov)

PZO is the FDA product code for Software For Visualization Of Vascular Anatomy And Intravascular Devices, a class II device type, regulated under 21 CFR 892.2050. FDA's definition for this code reads: "Visualization and measurement of blood vessels and intravascular devices for preoperational planning". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PZO
Device name
Software For Visualization Of Vascular Anatomy And Intravascular Devices
FDA definition
Visualization and measurement of blood vessels and intravascular devices for preoperational planning.
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
0

Clearances, product code PZO

By decision year
10 clearances under product code PZO with a decision year between 2017 and 2025, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PZO by decision year
YearClearances
20171
20191
20201
20222
20232
20241
20252

Applicants with the most clearances

Product code PZO
Applicants holding the most 510(k) clearances under product code PZO
ApplicantClearances
Sim&cure6
Mentice Spain S.L.2
ArteryFlow Technology Co., Ltd.1
Endo Vantage, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code