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510(k) Data Aggregation
K Number
K242500Device Name
LARALAB
Manufacturer
LARALAB GmbH
Date Cleared
2025-04-16
(237 days)
Product Code
QIH
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
LARALAB GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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
Device Description
LARALAB is a stand-alone software developed to enable cardiologists, radiologists, heart surgeons and healthcare professionals ("Users") to import, view and process Medical Images. In particular, the software generates pre-calculated automatic segmentations and measurements based on deterministic Deep Learning Algorithms. Based on the output of the Deep Learning Algorithms, the User is able to further visualize, assess and measure ("Case Planning") various anatomical structures of the heart in the context of cardiovascular procedures (e.g., TAVR) such as heart valves, heart chambers, cardiac tissue and vessels, as well as such vessels and tissue relevant as access routes.
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