# K002519: Vitrea 2, Version 2.1

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Oct 19, 2000 after 65 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
No predicates in its family tree.
271 later devices descend from it; 13 cite it directly.
0 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032748: VITREA2, Version 3.4 Medical Image Processing Software (2003), 170 descendants of its own
- K040305: VITREA2 Version 3.5 (2004), 164 descendants of its own
- K043333: VITREA2, Version 3.7 Medical Image Processing System (2004), 143 descendants of its own
- K052632: VITREA2 Version 3.8 Medical Image Processing Software (2005), 117 descendants of its own
- K061624: Vitrea, Version 3.9 (2006), 111 descendants of its own

## Recalls of this device
- Feb 5, 2013 · Class II · Z-1002-2013: Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitr

Source page: https://510kreport.com/device/K002519
Methodology: https://510kreport.com/methodology