# K091498: Vitrea Endovascular Stent Planning Software

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Jun 5, 2009 after 16 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913770 (1991). 46 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 1.
- K002519: Vitrea 2, Version 2.1, Vital Images, Inc. (2000) Summary page 1.
- K040852: Preview Treatment Planning Software, Medical Media Systems, Inc. (2004) Summary page 1.
- K060779: Advance Vessel Analysis II, GE Healthcare (2006) Summary page 1.

## Most influential descendants
- K143079: Endovascular Stent Planning Software (2014), 0 descendants of its own

## Recalls of this device
- Feb 23, 2010 · Not classified · Z-1600-2010: Vital images, Inc is issuing a recall notice on their medical device software in the use of CT Lung and CT Colon in Vitrea 5.1, Vitrea fX 3.0 or Vitre Enterprise Suite 1.2. because incorrect measureme

## Indications for use
Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea has the following additional indication: The Endovascular Stent Planning Software application is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The software provides 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The user can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements.

Source page: https://510kreport.com/device/K091498
Methodology: https://510kreport.com/methodology