Identifiers
- 510(k) Number
- K221456 FDA 510(k)
- FDA Product Code
- QAS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2080 FDA 510(k)
- Regulation Number
- 892.2080 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Rapid ICH is a radiological computer-assisted triage and notification software designed to assist physicians in the diagnosis and treatment of intracerebral hemorrhage (ICH). The software analyzes medical imaging data to provide rapid assessment and notification capabilities for cerebrovascular conditions.
The device is supplied as software and is intended for use in radiology departments. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device has received FDA 510(k) clearance with the product code QAS and is classified as a class II medical device.
Frequently asked questions
What is Rapid ICH software used for?
Rapid ICH is a radiological computer-assisted triage and notification software designed to assist physicians in the diagnosis and treatment of intracerebral hemorrhage (ICH). It analyzes medical imaging data to provide rapid assessment and notification capabilities for cerebrovascular conditions.
How is Rapid ICH supplied and what are its specifications?
Rapid ICH is supplied as software intended for use in radiology departments. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device has received FDA 510(k) clearance with the product code QAS and is classified as a class II medical device.
What regulatory approvals has Rapid ICH received?
Rapid ICH has received FDA 510(k) clearance with the product code QAS and is classified as a class II medical device. The clearance was granted through the traditional review process by the Radiology Advisory Committee.
What is the purpose of the Rapid ICH software in clinical practice?
The software is designed to help physicians rapidly assess and diagnose intracerebral hemorrhage through analysis of medical imaging data. It provides notification capabilities to assist in the timely treatment of cerebrovascular conditions in radiology departments.
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: iSchemaView Launches Rapid ANGIO, iSchemaView Rapid Technology Now Installed in More Than 500 Stroke ..., iSchemaview, Inc. (operating as RapidAI): Products, FDA Status ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221456 | Class II | Active |
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Manufacturer
- Manufacturer
- iSchemaView, Inc.
Sources (1)
- FDA 510(k) K221456 24 fields · synced Sep 25, 2026