# K233342: Cina-Aspects

- Pathway: 510(k) (Traditional)
- Applicant: Avicenna.Ai
- Decided: Mar 15, 2024 after 168 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: 2 generations back to DEN170022 (2017). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200760: Rapid ASPECTS, Ischemaview, Inc. (2020) Summary page 4.

## Indications for use
CINA-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 reorients images, segments and analyzes ASPECTS Regions of lnterest (ROIs). CINA-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. CINA-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 (acute) brain tissue injury during image interpretation. CINA-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS region definitions and highlighting ROIs and numerical scoring. Limitations: 1. CINA-ASPECT is not intended for primary interpretation of CT images. It is used to assist physician evaluation. 2. CINA-ASPECT has been validated in patients with known MCA or ICA unilateral occlusion prior to ASPECTS scoring. 3. CINA-ASPECTS is not suitable for use on brain scans displaying neurological pathologies other than acute stroke, such as tumors or abscesses, traumatic brain injuries, hemorrhagic transformation and hematoma. 4. Use of CINA-ASPECT in clinical settings other than brain ischemia within 12 hours from time last known well, caused by known ICA or MCA occlusions has not been tested. 5. CINA-ASPECTS has only been validated and is intended to be used in patient populations aged over 21. 6. CINA-ASPECTS has been validated and is intended to be used with images acquired with Canon Medical Systems Corporation, GE Healthcare, Philips Healthcare and Siemens Healthineers scanners. Contraindications/Exclusions/Cautions: ▪ Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate. ▪ Important streak artifacts and noisy images: Presence of important streak artifact and significant noise within the NCCT images that make the scan technically inadequate. ▪ Hemorrhagic Transformation, Hematoma.

Source page: https://510kreport.com/device/K233342
Methodology: https://510kreport.com/methodology