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Rapid ASPECTS (v3)

by iSchemaView, Inc.

510(k) K232156

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232156 Date19 Jan 2024ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
POK
Device class
Class II
Regulation
21 CFR Part 892.2060
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under K232156

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K232156
UDI-DISize and differences
Rapid 6.x
iSchemaView, Inc.
6.xB761R60 —On the market

Similar devices

Other devices filed under FDA product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

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