# K072821: Vitrea 4DCT

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Feb 20, 2008 after 141 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). 35 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 53 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.

## Most influential descendants
- K121213: Vitreaadvanced (2012), 8 descendants of its own
- K132853: Novapacs (2014), 6 descendants of its own
- K160371: NovaPACS (2016), 5 descendants of its own
- K142521: Synapse 3D Liver and Kidney Analysis (2014), 5 descendants of its own
- K171754: NovaPACS (2017), 4 descendants of its own

## Recalls of this device
- Oct 14, 2010 · Not classified · Z-0797-2011: Vital Images Inc., reported that a software defect exists with Vitrea fX 2.1, 3.0 and 3.1 CT Brain Analysis whereby the annotated numeric ROI values on a batched perfusion map are incorrect when creat

## 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. In addition, Vitrea 4DCT has the following indication: The Vitrea 4DCT Brain Perfusion option is intended for post processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.

Source page: https://510kreport.com/device/K072821
Methodology: https://510kreport.com/methodology