FDA.report

Veuron-Brain-pAb3

Primary DI
08800086200408
Brand
Veuron-Brain-pAb3
Company
Heuron Co., Ltd.
Model
AD-AWC03
Published
2024-02-29
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
LLZSystem, Image Processing, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions

SubmissionSupplement
K231642000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231642000Veuron-Brain-pAb3Heuron Co., Ltd.2023-10-13LLZ

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800086200408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800086200408088000862004088800086200408

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
08800086200217Heuron ICHST-ICT012024-06-24

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