FDA.reportPublic FDA data

Heuron ICH

Primary DI
08800086200217
Brand
Heuron ICH
Company
Heuron Co., Ltd.
Model
ST-ICT01
Published
2024-06-24
Public version status
New
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
K233247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233247000Heuron ICHHeuron Co., Ltd.2024-05-15QAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800086200217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800086200217088000862002178800086200217

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 quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694971646
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800086200408Veuron-Brain-pAb3AD-AWC032024-02-29
08800086200064Veuron-Brain-pAb2V-B-pAb-022022-02-18
08800086200026Veuron-Brain-pAbV-B-pAb-012021-11-09
08800086200019Veuron-Brain-mN1V-B-mN1-012022-07-19

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
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
B826CINAIPE100CINA-iPEAVICENNA.AIQAS2024-03-29
B761R51011RapidIschemaview, Inc.QAS2024-02-13
B761R51020RapidIschemaview, Inc.QAS2024-02-13
B761R5711RapidIschemaview, Inc.QAS2024-02-13
B761R5721RapidIschemaview, Inc.QAS2024-02-13
B761R610RapidIschemaview, Inc.QAS2024-02-13