# K233582: Rapid

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: Apr 22, 2024 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: 14 generations back to K896095 (1990). 20 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213165: Rapid, Ischemaview, Inc. (2022) Summary page 5.

## Most influential descendants
- K243350: Rapid Neuro3D (2025), 1 descendant of its own
- K251987: Rapid Aortic Measurements (2025), 0 descendants of its own
- K242123: Brainomix 360 e-CTA (2025), 0 descendants of its own

## Indications for use
Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians (medical analysis and decision making) and medical technicians (administrative case processing). 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. Rapid is indicated for use in Adults only. Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI, CT, and C-arm CT). Rapid C-arm CT Perfusion can be used to qualitatively assess cerebral hemodynamics in the angiography suite. The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue. 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. Rapid CT Perfusion and Rapid MR Perfusion can be used by physicians to aid in the selection of acute stroke patients (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery). Instructions for the use of contrast agents for this indication can be found in Appendix A of the User’s Manual. Additional information for safe and effective drug use is available in the product-specific iodinated CT and gadolinium-based MR contrast drug labeling. In addition to the Rapid imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions: • Bolus Quality: absent or inadequate bolus. • Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. • Presence of hemorrhage. • C-Arm CTP is not to be used in the Rapid Thrombectomy indication for patient selection criteria, other modalities should be consulted. Cautions: • C-Arm CTP provides qualitative data only, review other modalities prior to diagnosis. CBV and CBT are not absolute and CBT, CBV, MTT and Tmax are supported for qualitative interpretation of the perfusion maps only.

Source page: https://510kreport.com/device/K233582
Methodology: https://510kreport.com/methodology