# K241989: Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert

- Pathway: 510(k) (Traditional)
- Applicant: Cercare Medical A/S
- Decided: Dec 6, 2024 after 151 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: 14 generations back to K896095 (1990). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230016: Cercare Medical Neurosuite, Cercare Medical A/S (2023) Summary page 6.

## Most influential descendants
- K253831: CMN Capillary Function with Virtual Expert for MRI, CT and CBCT (2026), 0 descendants of its own

## Indications for use
Cercare Medical Neurosuite (CMN) and associated modules is an image processing software package to be used by trained professionals, including physicians and medical technicians. The CMN software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant imaging devices. CMN provides viewing capabilities of datasets acquired with CT and MRI. The Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT). The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module's DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. The Virtual Expert module allows the calculation of regions of interest and the visual inspection of time attenuation curves. For MRI, one clinical application is to visualize the apparent blood perfusion and diffusion and to calculate ADC threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke. For CT, one clinical application is to visualize the apparent blood perfusion and to calculate rCBF threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke. Areas of decreased perfusion appear as areas of changed signal intensity: * Lower signal intensity for CBF and CBV * Higher signal intensity for TTP, MTT, and Tmax

Source page: https://510kreport.com/device/K241989
Methodology: https://510kreport.com/methodology