# K260316: CMN Capillary Function with Oncology Virtual Expert

- Pathway: 510(k) (Traditional)
- Applicant: Cercare Medical A/S
- Decided: Jun 22, 2026 after 143 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: 3 generations back to K061855 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221738: NS-HGlio, Neosoma, Inc. (2022) Summary page 5.

## 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 MRI and CT. 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. Oncology Virtual Expert is intended for semi-automatic labeling, visualization, and volumetric quantification of brain glioma (WHO Grade II through IV), including glioblastoma (WHO Grade IV), astrocytoma (WHO Grade II, III, and IV), and oligodendroglioma (WHO Grade III), from a set of standard MRI images of adult patients who are known to have pathologically proven glioma. Volumetric measurements may be automatically compared to prior measurements when available; to minimize measurement variability, such longitudinal comparisons should be performed using the same scanner model and consistent acquisition parameters. Oncology Virtual Expert is not to be used for primary diagnosis and is intended to be used by trained professionals as an additional source of information for decision support.

Source page: https://510kreport.com/device/K260316
Methodology: https://510kreport.com/methodology