CINA

Primary DI
B826CINA100
Brand
CINA
Company
AVICENNA.AI
Model
1.0
Device description
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. Activenotifications 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.
Published
2020-12-14
Public version status
Update
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
K200855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200855000CINAAvicenna.Ai2020-06-24QAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B826CINA100PrimaryHIBCC0

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 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B826CINACSPINE100CINA-CSpine1.02024-10-07
B826CINAVCF100CINA-VCF1.02024-06-20
B826CINAASPECTS150CINA-ASPECTS1.52024-03-29
B826CINAIPE100CINA-iPE1.02024-03-29
B826CINACHEST100CINA CHEST1.02021-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B720BX360TRIAGELVO1430Triage LVOBRAINOMIX LIMITEDQAS2026-05-06
B720BX360TRIAGESTRO1430Triage StrokeBRAINOMIX LIMITEDQAS2026-05-06
00199874323862NeuroICHNEUROCAREAI INCQAS2026-04-24
08800066200589JLK-ICHJLK, Inc.QAS2026-03-25
08800066200596JLK-LVOJLK, Inc.QAS2026-03-25
08800066200602JLK-SDHJLK, Inc.QAS2026-03-25
07290018052365BriefCase TriageAIDOC MEDICAL LTDQAS2026-02-15
B720BX360TRIAGESTRO142Triage StrokeBRAINOMIX LIMITEDQAS2026-02-03
B720BX360TRIAGESTRO141Triage StrokeBRAINOMIX LIMITEDQAS2025-11-28
04056869959023syngo.CT Brain HemorrhageSiemens Healthcare GmbHQAS2025-11-21
04056869967844Update Label 127046Siemens Healthcare GmbHQAS2025-11-21
B720BX360TRIAGELVO1410Triage LVOBRAINOMIX LIMITEDQAS2025-10-16
B720BX360TRIAGEICH1120Triage ICHBRAINOMIX LIMITEDQAS2025-10-15
B720BX360TRIAGELVO1120Triage LVOBRAINOMIX LIMITEDQAS2025-10-15
B720BX360TRIAGEICH1400Triage ICHBRAINOMIX LIMITEDQAS2025-08-18
B720BX360TRIAGELVO1400Triage LVOBRAINOMIX LIMITEDQAS2025-08-18
B720BX360TRIAGESTRO1400Triage StrokeBRAINOMIX LIMITEDQAS2025-08-18
G140ANNALISECONTAINER60Annalise Critical Care AIHARRISON-AI MEDICAL PTY LTDQAS2025-07-28
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTDQAS2025-07-24
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL PTY LTDQAS2025-07-02
B761R60Rapid Ischemaview, Inc.QAS2025-05-07
00882916001025StrokeSENS LVOCircle Cardiovascular Imaging IncQAS2025-02-05
07290018052273BriefCase TriageAIDOC MEDICAL LTDQAS2024-11-24
07290018052297BriefCase TriageAIDOC MEDICAL LTDQAS2024-11-24
B826CINACSPINE100CINA-CSpineAVICENNA.AIQAS2024-10-07
08800086200217Heuron ICHHeuron Co., Ltd.QAS2024-06-24
B826CINAIPE100CINA-iPEAVICENNA.AIQAS2024-03-29
B761R51011RapidIschemaview, Inc.QAS2024-02-13
B761R51020RapidIschemaview, Inc.QAS2024-02-13
B761R5711RapidIschemaview, Inc.QAS2024-02-13