Identifiers
- 510(k) Number
- K232156 FDA 510(k)
- FDA Product Code
- POK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2060 FDA 510(k)
- Regulation Number
- 892.2060 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Rapid ASPECTS (v3) is a computer-assisted diagnostic software tool designed to assist clinicians in evaluating brain CT images for early ischemic stroke. The software automatically analyzes specific brain regions to generate an ASPECT score, which helps characterize ischemic damage by providing standardized, AI-derived scores and annotated images.
This Class II medical device is categorized under radiology and is regulated under FDA 510(k) clearance K232156. It is intended for use by radiologists to facilitate accurate and consistent stroke assessment.
Frequently asked questions
What is the primary function of the Rapid ASPECTS (v3) software?
Rapid ASPECTS (v3) is a computer-assisted diagnostic tool designed to assist radiologists in evaluating brain CT images. It automatically analyzes specific brain regions to generate an ASPECT score and provides annotated images to help characterize ischemic damage.
Who is the intended user for this diagnostic software?
This software is intended for use by radiologists. It is designed to facilitate accurate and consistent stroke assessment by providing standardized, AI-derived scores during the evaluation of brain CT images.
What is the regulatory status of Rapid ASPECTS (v3)?
Rapid ASPECTS (v3) is a Class II medical device that has received FDA 510(k) clearance under the number K232156. It is categorized under radiology and is regulated under the product code POK.
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 Rapid Aspects (v3) - allmed.wiki, Rapid ASPECTS (v3) | FDA Radiology AI Device - radaislice.com, K232156 FDA 510 (k) - Rapid ASPECTS (v3) | Ischemaview, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232156 | Class II | Active |
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Manufacturer
- Manufacturer
- iSchemaView, Inc.
Sources (1)
- FDA 510(k) K232156 24 fields · synced Sep 27, 2026