# K202793: Cercare Medical Neurosuite

- Pathway: 510(k) (Traditional)
- Applicant: Cercare Medical Aps
- Decided: May 17, 2021 after 237 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: 12 generations back to K896095 (1990). 13 ancestors in all.
3 later devices descend 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)
- K172477: iSchemaView RAPID, Ischemaview, Inc. (2018) Summary page 4.

## Most influential descendants
- K230016: Cercare Medical Neurosuite (2023), 2 descendants of its own
- K241989: Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert (2024), 1 descendant of its own
- K253831: CMN Capillary Function with Virtual Expert for MRI, CT and CBCT (2026), 0 descendants of its own

## Indications for use
Cercare Medical Neurosuite and associated modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians. The 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 MR imaging devices. Cercare Medical Neurosuite provides viewing capabilities, whereas 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). 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.

Source page: https://510kreport.com/device/K202793
Methodology: https://510kreport.com/methodology