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CINA-CSpine

FDA UDIEUDAMED

Class II (US FDA UDI)

by Avicenna.ai

Identity

Trade Name
CINA-CSpine FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
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 [...]. FDA UDI
Model / Reference
1.0 FDA UDI
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 [...]. FDA UDI

Identifiers

Primary DI / UDI-DI
B826CINACSPINE100 FDA UDI
510(k) Number
K240942 FDA UDI
FDA Product Code
QAS FDA UDI
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology DICOM image processing application software

CINA-CSpine by Avicenna.ai — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Radiology DICOM image processing application software.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avicenna.ai

Sources (2)

  • FDA UDI 1fefa648-ccf6-4d0c-ae51-c975945b983e 34 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 3, 2026