# K172477: iSchemaView RAPID

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: Apr 19, 2018 after 246 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: 11 generations back to K896095 (1990). 12 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121447: Ischema View Rapid, Ischemaview, Inc. (2013) Summary page 4.

## Most influential descendants
- K182130: iSchemaView RAPID (2018), 9 descendants of its own
- K213165: Rapid (2022), 7 descendants of its own
- K233582: Rapid (2024), 3 descendants of its own
- K202793: Cercare Medical Neurosuite (2021), 3 descendants of its own
- K192692: Brainomix 360 e-CTA (2020), 3 descendants of its own

## Indications for use
iSchemaView's RAPID is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a 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 compliant imaging devices. The iSchemaView RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CT-P), CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT). The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data. The Dynamic Analysis 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.

Source page: https://510kreport.com/device/K172477
Methodology: https://510kreport.com/methodology