Identifiers
- 510(k) Number
- K243350 FDA 510(k)
- FDA Product Code
- QIH 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)
Rapid Neuro3D is an AI-enabled medical device designed for the viewing, processing, and analysis of CT and MRI neuroimaging. It provides physicians with fast, fully automated, and easy-to-interpret imaging results to aid in the assessment of patients with suspected stroke, both ischemic and hemorrhagic.
The device is supplied as software and is intended for use in clinical settings. It has received FDA 510(k) clearance with marketing authorization (submission K243350, final decision 2025-01-22) and was reviewed by the Radiology advisory committee. The device is part of the comprehensive RAPID Enterprise™ Platform by iSchemaView, Inc.
Frequently asked questions
What is the Rapid Neuro3D device used for?
Rapid Neuro3D is an AI-enabled medical device designed for viewing, processing, and analyzing CT and MRI neuroimaging to aid in the assessment of patients with suspected stroke, including both ischemic and hemorrhagic types.
How is the Rapid Neuro3D device supplied?
The device is supplied as software and is intended for use in clinical settings as part of the comprehensive RAPID Enterprise™ Platform by iSchemaView, Inc.
What regulatory authorization has the Rapid Neuro3D received?
Rapid Neuro3D has received FDA 510(k) clearance with marketing authorization (submission K243350, final decision 2025-01-22) and was reviewed by the Radiology advisory committee.
What types of imaging can be processed with the Rapid Neuro3D?
The device is specifically designed for processing and analyzing CT and MRI neuroimaging, providing physicians with fast, fully automated, and easy-to-interpret results.
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, Inc.: Rapid Neuro3D (FDA-cleared AI medical device), Rapid Neuro3D Review: Pricing, FDA Status & Alternatives | Physician AI ..., iSchemaView Rapid Technology Now Installed in More Than 500 Stroke ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243350 | Class II | Active |
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Manufacturer
- Manufacturer
- iSchemaView, Inc.
Sources (1)
- FDA 510(k) K243350 24 fields · synced Sep 24, 2026