# K244012: Mosaic (V1.0.1)

- Pathway: 510(k) (Traditional)
- Applicant: Navier Medical
- Decided: Jun 16, 2025 after 172 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
Longest line of descent: 13 generations back to K913770 (1991). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221463: ElucidVivo A.3, Elucid Bioimaging, Inc. (2022) Summary page 5.

## Indications for use
Mosaic V1.0.1 is a medical image analysis system that allows the viewing, processing, and analysis of multi-dimensional digital images acquired with contrast from CT imaging devices. Mosaic V1.0.1 is intended to assist trained medical professionals in the stratification of patients suspected or identified to have atherosclerosis as well as stratification of patients suspected or identified to have aneurysmal disease of the aorta or carotid, iliac, femoral and popliteal arteries. The software enables post processing of images obtained using a multidetector CT and provides tools for the measurement and visualisation of arterial vessels and any disease present, including editing of contrasted lumen and artery boundaries. Any processed artery can be selected to view: the vessel in 3D; color-coded interactive data maps displayed on the 3D vessel; curved, straightened and cross-sectional MPR views of the vessel; and quantitative data from regions of interest. Data includes standard 2D distance measurements as well as stenosis, Hounsfield unit statistics, and tissue volumes. Typical users of Mosaic V1.0.1 outputs are trained medical professionals, including radiologists and clinicians. Typical operators of Mosaic V1.0.1 are those suitably trained in the use of the software. Mosaic V1.0.1 is intended to complement standard of care but is not intended to provide a diagnosis or clinical recommendation.

Source page: https://510kreport.com/device/K244012
Methodology: https://510kreport.com/methodology