CINA-iPE

GUDID B826CINAIPE100

CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-enhanced CT scans (not dedicated CTPA protocol) for other clinical indications than pulmonary embolism suspicion, including at least a part of the lung. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (iPE). The device is indicated for adults and transitional adolescents (18 to 21 years old but treated as adults). CINA-iPE uses an artificial intelligence algorithm to analyze images and highlight cases with detected incidental PE on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected incidental PE findings. The device is not designed to detect PE in subsegmental arteries. Notifications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. The results of CINA-iPE are intended to be used in conjunction with other patient information and based on professional judgment to assist with the 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: B826CINAIPE100
• NIH Device Record Key: c7290824-1311-43fe-a191-265dd9ec0af4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CINA-iPE
• 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	B826CINAIPE100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233968

FDA Product Code

• QAS: Radiological Computer-Assisted Triage And Notification Software

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

• 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: 2024-04-08CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-enhanced CT scans (not dedicated CTPA protocol) for other clinical indications than pulmonary embolism suspicion, including at least a part of the lung. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (iPE). The device is indicated for adults and transitional adolescents (18 to 21 years old but treated as adults). CINA-iPE uses an artificial intelligence algorithm to analyze images and highlight cases with detected incidental PE on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected incidental PE findings. The device is not designed to detect PE in subsegmental arteries. Notifications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a diagnostic device. The results of CINA-iPE are intended to be used in conjunction with other patient information and based on professional judgment to assist with the triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
• 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