# K213165: Rapid

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: Feb 8, 2022 after 133 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: 13 generations back to K896095 (1990). 19 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211222: qER-Quant, Qure.Ai Technologies (2021) Summary page 5.
- K182130: iSchemaView RAPID, Ischemaview, Inc. (2018) Summary page 5.

## Most influential descendants
- K233582: Rapid (2024), 3 descendants of its own
- K243350: Rapid Neuro3D (2025), 1 descendant of its own
- K233512: Rapid (6.0) (2024), 1 descendant of its own
- K261368: Rapid Platform (R6.7) (2026), 0 descendants of its own
- K251987: Rapid Aortic Measurements (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 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. Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), 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 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

Source page: https://510kreport.com/device/K213165
Methodology: https://510kreport.com/methodology