# K051840: Ensite Verismo Software

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Aug 15, 2005 after 39 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
113 later devices descend from it; 2 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vital Images, Inc - Vitrea®2: named in the summary without a submission number

## Most influential descendants
- K071331: Vitrea Version 4.0 (2007), 82 descendants of its own
- K101697: Ensite Verismo Segmentation Tool V.2.0 (2010), 29 descendants of its own
- K160187: Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 (2016), 28 descendants of its own
- K172396: EnSite Velocity Cardiac Mapping System v5.2 (2018), 27 descendants of its own
- K182644: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (2018), 26 descendants of its own

## Indications for use
The EnSite Verismo TM Segmentation Tool (EV 1000) is indicated for use in generating 3D models from slice-based DICOM3 image data. Generated models are intended to be displayed on the EnSite® System.

Source page: https://510kreport.com/device/K051840
Methodology: https://510kreport.com/methodology