CINA CHEST - CINA CHEST is a radiological computer aided - AVICENNA.AI

Duns Number:271198112

Device Description: CINA CHEST is a radiological computer aided triage and notification software indicated for CINA CHEST is a radiological computer aided triage and notification software indicated for use in the analysis of Chest and Thoraco-abdominal CT angiographies. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communicating suspected positive findings of (1) Chest CT angiographies for Pulmonary Embolism (PE) and (2) Chest or Thoraco-abdominal CT angiographies for Aortic Dissection (AD). CINA CHEST uses an artificial intelligence algorithm to analyze images and highlight cases with detected PE and AD on a standalone Web application in parallel to the ongoing standard of care image interpretation.The user is presented with notifications for cases with suspected PE or AD findings. 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 CHEST 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.

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More Product Details

Catalog Number

-

Brand Name

CINA CHEST

Version/Model Number

1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K210237

Product Code Details

Product Code

QAS

Product Code Name

Radiological Computer-Assisted Triage And Notification Software

Device Record Status

Public Device Record Key

c38713af-6ae8-4d13-87b0-8a42139af976

Public Version Date

June 10, 2021

Public Version Number

1

DI Record Publish Date

June 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVICENNA.AI" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2