CINA-CSpine

Primary DI
B826CINACSPINE100
Brand
CINA-CSpine
Company
AVICENNA.AI
Model
1.0
Device description
CINA-CSpine is a radiological computer-assisted triage and notification software device. CINA-CSpine runs on a standard “off the shelf” server/workstation and consists of CSpine Image Processing Application, which can be integrated, deployed and used with the CINA Platform or other medical image communications devices. CINA-CSpine receives cervical spine CT scans identified by the CINA Platform or other medical image communications device, processes them using algorithmic methods involving execution of multiple computational steps to identify the suspected positive findings compatible with acute cervical spine fractures and generates results files to be transferred by CINA Platform or a similar medical image communications device for output to a PACS system or workstation for worklist prioritization.To identify the suspected presence of cervical fractures, the device uses a deep learning model trained end-to-end on 1,338 cases acquired from US and France, representing a distribution of fracture presentations, locations and acquisition protocols, including multiple scanner models. Additional deep learning models are used to locate the individual vertebrae to exclude images that do not conform to the expected field of view.DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspected positive findings of a cervical spine fracture, then active notifications on the flagged series are sent to the worklist application. The Worklist Application displays the active notification of new studies with suspected findings when they come in. All the cervical spine CT studies which include at least 5 visible cervical vertebrae received by CINA-CSpine device are displayed in the worklist and those on which the algorithms have detected a suspected finding are marked with an icon [...].
Published
2024-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QASRadiological Computer-Assisted Triage And Notification Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QASRadiological Computer-Assisted Triage And Notification SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240942000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240942000CINA-CSpineAvicenna.Ai2024-09-12QAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B826CINACSPINE100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
271198112
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B826CINAVCF100CINA-VCF1.02024-06-20
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B826CINAIPE100CINA-iPE1.02024-03-29
B826CINACHEST100CINA CHEST1.02021-06-02
B826CINA100CINA1.02020-12-14

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