# K200760: Rapid ASPECTS

- Pathway: 510(k) (Traditional)
- Applicant: Ischemaview, Inc.
- Decided: Jun 26, 2020 after 94 days
- Product code: POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170022 (2017). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170022: QuantX, Quantitative Insights, Inc. (2017) Summary page 4.

## Most influential descendants
- K221564: Brainomix 360 e-ASPECTS (2023), 2 descendants of its own
- K250221: StrokeSENS ASPECTS Software Application (2025), 0 descendants of its own
- K243294: Brainomix 360 e-ASPECTS (2025), 0 descendants of its own
- K233342: Cina-Aspects (2024), 0 descendants of its own
- K232156: Rapid ASPECTS (v3) (2024), 0 descendants of its own

## Indications for use
Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and segments and analyzes ASPECTS Regions of lnterest (ROIs). Rapid ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. Rapid ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device provides information that may be useful in the characterization of early ischemic brain tissue injury during image interpretation (within 6 hours). Rapid ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROIs and numerical scoring. Limitations: 1. Rapid ASPECTS is not intended for primary interpretation of CT images, it is used to assist physician evaluation. 2. Rapid ASPECTS has been validated in patients with known MCA or ICA Occlusion prior to ASPECT scoring. 3. Use of the Rapid ASPECTS Module in clinical settings other than early brain ischemia (within 6 hours) caused by known ICA or MCA occlusions has not been tested. 4. Rapid ASPECTS has been validated and is intended to be used on GE Lightspeed VCT Scanners. Contraindications/Exclusions/Cautions: • Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. • Hemorrhagic Transformation, Hematoma • Very thin or no Ventricles

Source page: https://510kreport.com/device/K200760
Methodology: https://510kreport.com/methodology