Identifiers
- 510(k) Number
- K252526 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Rapid DeltaFuse is an image processing system intended for radiological applications. It processes and analyzes medical images to assist clinicians in diagnostic decision‑making.
The device was cleared through an FDA 510(k) submission (K252526) and is classified as a Class II system, image processing, radiological device (product code LLZ). It is submitted by Ischemaview, Inc. of Golden, Colorado, and marketed by iSchemaView, Inc.
Frequently asked questions
What is the Rapid DeltaFuse system used for?
The Rapid DeltaFuse is an image processing system designed for radiological applications. It processes and analyzes medical images to assist clinicians in making diagnostic decisions.
How is the Rapid DeltaFuse supplied and is it single-use or reusable?
The device is supplied as an image processing system, which is typically a software-based solution that can be installed on compatible hardware. The description does not specify whether it is single-use or reusable, as it is a digital system rather than a physical medical instrument.
What regulatory approvals does the Rapid DeltaFuse have?
The Rapid DeltaFuse has received FDA 510(k) clearance (K252526) as a Class II system, image processing, radiological device (product code LLZ). It was submitted by Ischemaview, Inc. and is marketed by iSchemaView, Inc.
Are there different models or sizes available for the Rapid DeltaFuse?
The device data does not specify different models or sizes for the Rapid DeltaFuse. It is described as an image processing system without mention of variations in size or model configurations.
What is the intended storage environment for the Rapid DeltaFuse system?
The device data does not specify storage requirements for the Rapid DeltaFuse. As a digital image processing system, it would typically be stored on compatible computer hardware following standard IT equipment storage guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF August 26, 2025 iSchemaView, Inc. James Rosa Chief Regulatory and ..., K252526 FDA 510(k) - Rapid DeltaFuse | Ischemaview, Inc., Rapid DeltaFuse | FDA Radiology AI Device, Ischemaview Rapid DeltaFuse - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252526 | Class II | Active |
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Manufacturer
- Manufacturer
- iSchemaView, Inc.
Sources (1)
- FDA 510(k) K252526 24 fields · synced Sep 24, 2026