Cina

CINA is a radiological computer-assisted triage and notification software device. The software system is based on algorithm-programmed components and is comprised of a standard…

Registry build 21.09.26

CINA is a radiological computer-assisted triage and notification software device. The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image processing applications. DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspicious results of an intracranial hemorrhage (ICH) or a large vessel occlusion (LVO), then notifications on the flagged series are sent to the Worklist Application. The Worklist Application (on premise) displays the pop-up notifications of new studies with suspected findings when they come in, and provides both active and passive notifications. Active notifications are in the form of a small pop-up containing patient name, accession number and the type of suspected findings (ICH or LVO). All the non-enhanced head CT images and head CT angiographies studies received by CINA device are displayed in the worklist and those on which the algorithms have detected a suspected finding (ICH or LVO) are marked with an icon (i.e., passive notification). In addition, a compressed, small black and white image that is marked “not for diagnostic use” is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.

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
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) K200855
Record published 2020-12-14
Record revised 2023-12-04 (version 5)

Specifications

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

Catalogue Numbers

Catalogue numbers for Cina
Catalogue number Size Status
1.0 In distribution

Same Product Code

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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