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 Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device IDB826CINAVCF100
NIH Device Record Keyb9606c62-4b4b-43b0-8339-09f557feb245
Commercial Distribution StatusIn Commercial Distribution
Brand NameCINA-VCF
Version Model Number1.0
Company DUNS271198112
Company NameAVICENNA.AI
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB826CINAVCF100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFMRadiological Computer-Assisted Prioritization Software For Lesions

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-28
Device Publish Date2024-06-20

Devices Manufactured by AVICENNA.AI

B826CINAVCF100 - CINA-VCF2024-06-28CINA-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-VCF2024-06-28 CINA-VCF is a radiological computer aided triage and notification software indicated for use in patients aged 50 years and over
B826CINAASPECTS150 - CINA-ASPECTS2024-04-08 CINA-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characteriz
B826CINAIPE100 - CINA-iPE2024-04-08 CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-en
B826CINACHEST100 - CINA CHEST2021-06-10 CINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thor
B826CINA100 - CINA2020-12-22 CINA is a radiological computer-assisted triage and notification software device. The software system is based on algorithm-prog
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