CINA-VCF

GUDID B826CINAVCF100

CINA-VCF is a radiological computer aided triage and notification software indicated for use in patients aged 50 years and over undergoing non-enhanced or contrast-enhanced CT scans which include the chest and/or abdomen. The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCF) findings. CINA-VCF uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. This document is the property of Avicenna.AI and cannot be reproduced without written authorisation. The results of CINA-VCF are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.

AVICENNA.AI

Radiology DICOM image processing application software

• Primary Device ID: B826CINAVCF100
• NIH Device Record Key: b9606c62-4b4b-43b0-8339-09f557feb245
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CINA-VCF
• Version Model Number: 1.0
• 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	B826CINAVCF100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240612

FDA Product Code

• QFM: Radiological Computer-Assisted Prioritization Software For Lesions

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: 2024-06-28
• Device Publish Date: 2024-06-20

Devices Manufactured by AVICENNA.AI

• B826CINAVCF100 - CINA-VCF: 2024-06-28CINA-VCF is a radiological computer aided triage and notification software indicated for use in patients aged 50 years and over undergoing non-enhanced or contrast-enhanced CT scans which include the chest and/or abdomen. The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCF) findings. CINA-VCF uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. This document is the property of Avicenna.AI and cannot be reproduced without written authorisation. The results of CINA-VCF are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
• B826CINAVCF100 - CINA-VCF: 2024-06-28 CINA-VCF is a radiological computer aided triage and notification software indicated for use in patients aged 50 years and over
• 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