CINA-CSpine

CINA-CSpine is radiological triage and notification software for analysis of cervical spine CT images. Its stated role is to flag cases with suspected findings compatible with acute…

Registry build 21.09.26

CINA-CSpine is radiological triage and notification software for analysis of cervical spine CT images. Its stated role is to flag cases with suspected findings compatible with acute cervical spine fractures, including nondisplaced fracture lines or displaced fragments.

The software receives cervical spine CT scans and processes them to identify suspected positive findings compatible with acute cervical spine fractures, then generates results files.

Listed Item

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 […].

Image Analysis and Review

The application uses artificial intelligence to analyze images and highlight detected findings. Clinicians remain responsible for reviewing full images under standard care.

1manufacturer
1catalogue number
5510(k) clearances naming this product code

Who Else Makes It

Registered in Beijing.

Chinese manufacturers registered for FDA product code QAS
Manufacturer City Province Registered as Device types
Beijing Infervision Healthcare Medical Technology Co., Ltd. Beijing Beijing Complaint-file establishment 4

Record

Regulatory record for CINA-CSpine
Listed by Avicenna.ai, France
FDA product code QAS
Device type Radiological Computer-Assisted Triage And Notification Software
Device class Class 2
Regulation 21 CFR 892.2080
Establishment Complaint-file establishment, Manufacturer
510(k) K240942
Record published 2024-10-07

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for CINA-CSpine
Catalogue number Size Status
1.0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Viz LVO Viz.ai, Inc. 12
Triage Stroke Brainomix Limited 5
BriefCase Triage Aidoc Medical Ltd. 5
Triage LVO Brainomix Limited 5
BriefCase Aidoc Medical Ltd. 3
HealthICH Nano-X AI Ltd. 3
Annalise Triage Harrison-AI Medical Pty Ltd 3
Triage ICH Brainomix Limited 3
syngo.CT Brain Hemorrhage Siemens Healthcare Limited 2
AccipioIx Maxq AI Ltd 2
Viz ICH Viz.ai, Inc. 2
qER Qure.ai Technologies Private Limited 1

Showing 12 of 29. All products under Radiological Computer-Assisted Triage And Notification Software

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K240942 2024-09-12
K233968 2024-03-13
K221716 2022-11-22
K210237 2021-05-19
K200855 2020-06-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer