Software For Visualization Of Vascular Anatomy And Intravascular Devices
The Software for Visualization of Vascular Anatomy and Intravascular Devices is a software-based medical device intended for the visualization and measurement of blood vessels and intravascular devices to support preoperative planning in vascular and interventional procedures. It is classified as a Class 2 device under regulation 892.2050, requiring 510(k) premarket notification, falling within the Radiology (RA) medical specialty with Cardiovascular (CV) review. The product code is PZO. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PZO
- Device Class
- FDA class 2
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Visualization and measurement of blood vessels and intravascular devices for preoperational planning.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253122 | Sim&Size | Dec 23, 2025 | Substantially Equivalent | Sim&Cure |
| K250160 | ANKYRAS | May 06, 2025 | Substantially Equivalent | Mentice Spain S.L. |
| K242124 | Sim&Size | Dec 14, 2024 | Substantially Equivalent | Sim&Cure |
| K230006 | Ankyras | Dec 28, 2023 | Substantially Equivalent | Mentice Spain S.L. |
| K222664 | Sim&Size | Jan 27, 2023 | Substantially Equivalent | Sim&Cure |
| K213838 | AneuGuide | Jun 01, 2022 | Substantially Equivalent | ArteryFlow Technology Co., Ltd. |
| K212373 | Sim&Size | Jan 27, 2022 | Substantially Equivalent | Sim&Cure |
| K202322 | Sim&Size | Dec 31, 2020 | Substantially Equivalent | Sim&Cure |
| K190049 | Sim&Size | Sep 17, 2019 | Substantially Equivalent | Sim&Cure |
| K171534 | SurgicalPreview | Nov 08, 2017 | Substantially Equivalent | Endo Vantage, LLC |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.