# K252526: Rapid DeltaFuse

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: Aug 26, 2025 after 15 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.
No later device cites it as a predicate yet.
0 of 21 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.

## Indications for use
Rapid DeltaFuse 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 DeltaFuse provides both viewing and analysis capabilities for imaging datasets acquired with Non-Contrast CT (NCCT) images. The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue including overlays of time differentiated scans of the same patient. Rapid DeltaFuse is intended for use for adults.

Source page: https://510kreport.com/device/K252526
Methodology: https://510kreport.com/methodology