FDA.report

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
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
QASRadiological Computer-Assisted Triage And Notification Software

Product Code Classifications

CodeDeviceSpecialtyClass
QASRadiological Computer-Assisted Triage And Notification SoftwareRadiology2

Premarket Submissions

SubmissionSupplement
K233247000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K233247000Heuron ICHHeuron Co., Ltd.2024-05-15QAS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800086200217PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
694971646
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DIBrandModelCatalogPublished
08800086200408Veuron-Brain-pAb3AD-AWC032024-02-29

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B720BX360TRIAGELVO1110Triage LVOBRAINOMIX LIMITEDQAS2023-10-03
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00811852030301Viz LVOVIZ.AI, INC.QAS2022-04-06
00811852030318Viz ICHVIZ.AI, INC.QAS2022-04-06
08720299502338StrokeViewer LVO detectionNICo-Lab B.V.QAS2022-03-08
00860001219531AccipioIxMAXQ AI LTDQAS2021-09-14
00850003095011InferRead CT Stroke.AIInfervision US IncQAS2021-08-18
B826CINACHEST100CINA CHESTAVICENNA.AIQAS2021-06-02