FDA.report

Veuron-Brain-mN1

Primary DI
08800086200019
Brand
Veuron-Brain-mN1
Company
Heuron Co.,Ltd.
Model
V-B-mN1-01
Published
2022-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LNHSystem, Nuclear Magnetic Resonance Imaging

Product Code Classifications

CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800086200019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800086200019088000862000198800086200019

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 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
08800086200064Veuron-Brain-pAb2V-B-pAb-022022-02-18
08800086200026Veuron-Brain-pAbV-B-pAb-012021-11-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00857534006929Neuro II-SEIMRIS Imaging, Inc.LNH2026-03-20
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B6693300MRIaudio Over-Ear HeadphonesMRIAUDIO, INC.LNH2026-03-06
B66915070MRIaudioMRIAUDIO, INC.LNH2026-03-03
04068151995268MAGNETOM LuminaSiemens Healthineers AGLNH2026-02-23
04068151995312MAGNETOM Sola FitSiemens Healthineers AGLNH2026-02-23
00884838104402IngeniaPhilips Medical Systems Nederland B.V.LNH2026-01-27
04056869299594MAGNETOM Flow.NeoSiemens Healthcare GmbHLNH2026-01-19
04068151034196MAGNETOM Flow.EliteSiemens Healthcare GmbHLNH2026-01-19
00884838128415Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128422Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128439Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128446Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128453Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128460Ingenia Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128477Ingenia, MR5300, MR7700, AchievaPhilips Medical Systems Nederland B.V.LNH2026-01-07
00884838128484Ingenia 3.0TPhilips Medical Systems Nederland B.V.LNH2026-01-07
00884838128514IngeniaPhilips Medical Systems Nederland B.V.LNH2026-01-07
00884838128521Ingenia ElitionPhilips Medical Systems Nederland B.V.LNH2026-01-07
00884838128552IngeniaPhilips Medical Systems Nederland B.V.LNH2026-01-07
00884838128569MR 7700Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838128576MR 7700Philips Medical Systems Nederland B.V.LNH2026-01-07
00884838108707Magnetic Resonance Imaging SystemsPhilips Medical Systems Nederland B.V.LNH2025-12-23
00850043319160Swoop Portable MR Imaging ScannerHyperfine Operations, Inc.LNH2025-12-04
04547410565195ECHELON SynergyFUJIFILM CORPORATIONLNH2025-11-30
B672MYOSTRAIN060100MyoStrainMYOCARDIAL SOLUTIONS, INC.LNH2025-11-11
00884838098886Ingenia, Achevia, MR 5300Philips Medical Systems Nederland B.V.LNH2025-10-16
00884838105805IngeniaPhilips Medical Systems Nederland B.V.LNH2025-10-16
00884838105812IngeniaPhilips Medical Systems Nederland B.V.LNH2025-10-16
00884838105829IngeniaPhilips Medical Systems Nederland B.V.LNH2025-10-16