# K242500: Laralab

- Pathway: 510(k) (Traditional)
- Applicant: Laralab GmbH
- Decided: Apr 16, 2025 after 237 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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
Longest line of descent: 7 generations back to K954678 (1996). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153736: 3mensio Workstation, Pie Medical Imaging BV (2016) Summary page 5.

## Indications for use
LARALAB enables visualization, assessment and measurement of cardiovascular structures for: - Preprocedural planning and sizing for cardiovascular interventions and surgery - Postprocedural image review To facilitate the above, LARALAB provides general functionality such as: - Automatic segmentation of cardiovascular structures and other objects of interest (calcifications) - Automatic measurements - Manual measurement and adjustment tools - Visualization and image reconstruction techniques: Multiplanar Reconstruction (MPR), Surface rendering - Reporting tools

Source page: https://510kreport.com/device/K242500
Methodology: https://510kreport.com/methodology