FDA.reportPublic FDA data

InferRead CT Stroke.AI

Primary DI
00850003095011
Brand
InferRead CT Stroke.AI
Company
Infervision US Inc
Model
1.1.0.0
Device description
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH).
Published
2021-08-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K211179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211179000InferRead CT Stroke.AIInfervision Medical Technology Co., Ltd.2021-08-12QAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003095011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003095011008500030950118500030950110850003095011

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstationA freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.

Regulatory Flags#

DUNS number
117164757
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003095004InferRead Lung CT.AI 2.1.2.12.1.2.12021-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811852030370Viz ICHVIZ.AI, INC.QAS2026-08-03
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
B761R60RapidIschemaview, 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