# Rapid ASPECTS (v3)

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/rapid-aspects-v3-pok>
- Manufacturer: [iSchemaView, Inc.](https://devicerts.com/manufacturers/ischemaview-inc) (United States)
- Device class: Class II (US FDA)
- FDA product code: POK

## Overview

*AI-generated summary, 2026-09-27. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K232156 · decision 2024-01-19 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K232156 [FDA 510(k)]
- FDA product code: POK [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.2060 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Rapid ASPECTS (v3), iSchemaView, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/rapid-aspects-v3-pok (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/rapid-aspects-v3-pok.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/rapid-aspects-v3-pok
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.