CINA-ASPECTS

GUDID B826CINAASPECTS150

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

AVICENNA.AI

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• Primary Device ID: B826CINAASPECTS150
• NIH Device Record Key: 9697623c-ce54-4a68-89b3-57b422338a6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CINA-ASPECTS
• Version Model Number: 1.5
• Company DUNS: 271198112
• Company Name: AVICENNA.AI
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B826CINAASPECTS150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233342

FDA Product Code

• POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-08
• Device Publish Date: 2024-03-29

Devices Manufactured by AVICENNA.AI

• B826CINAASPECTS150 - CINA-ASPECTS: 2024-04-08CINA-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
• B826CINAASPECTS150 - CINA-ASPECTS: 2024-04-08 CINA-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characteriz
• B826CINAIPE100 - CINA-iPE: 2024-04-08 CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-en
• B826CINACHEST100 - CINA CHEST: 2021-06-10 CINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thor
• B826CINA100 - CINA: 2020-12-22 CINA is a radiological computer-assisted triage and notification software device. The software system is based on algorithm-prog