FDA.reportPublic FDA data

Brainomix 360 Hyperdensity

Primary DI
B720BX360HYPERDENSI1440
Brand
Brainomix 360 Hyperdensity
Company
BRAINOMIX LIMITED
Model
14.4
Published
2026-09-18
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

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260406000Brainomix 360 HyperdensityBrainomix Limited2026-06-12QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B720BX360HYPERDENSI1440PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Brain CT/MRI clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire computed tomography (CT) and/or magnetic resonance imaging (MRI) data of the brain (includes intracranial vessels), to support a healthcare provider with clinical assessment (e.g., diagnosis, triage) of a brain condition (e.g., occlusion, aneurysm, haemorrhage, stroke, neurodegenerative disease). It is not dedicated to treatment planning or surgical navigation, and does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
216967482
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
B720BX360EASPECTS1430e-ASPECTS14.32026-05-06
B720BX360ECTA1430e-CTA14.32026-05-06
B720BX360ECTP1430e-CTP14.32026-05-06
B720BX360EMRI1430e-MRI14.32026-05-06
B720BX360TRIAGELVO1430Triage LVO14.32026-05-06
B720BX360TRIAGESTRO1430Triage Stroke14.32026-05-06
B720BX360EASPECTS1210Brainomix e-ASPECTS12.12026-03-30
B720BX360ECTA1210Brainomix 360 e-CTA12.12026-03-30
B720BX360ECTP1210Brainomix 360 e-CTP12.12026-03-30
B720BX360ELUNG230Brainomix 360 e-Lung2.32026-03-30
B720BX360EMRI1210Brainomix 360 e-MRI12.12026-03-30
B720BX360EASPECTS1420e-ASPECTS14.22026-02-03
B720BX360ECTA1420e-CTA14.22026-02-03
B720BX360ECTP1420e-CTP14.22026-02-03
B720BX360EMRI1420e-MRI14.22026-02-03
B720BX360TRIAGESTRO142Triage Stroke14.22026-02-03
B720BX360TRIAGESTRO141Triage Stroke14.12025-11-28
B720BX360TRIAGELVO1410Triage LVO14.12025-10-16
B720BX360EASPECTS1200e-ASPECTS12.02025-10-15
B720BX360ECTA1200Brainomix 360 e-CTA12.02025-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
04262352350059DS Core CBCT AnatomyZetta25 AGQIH2026-08-26
00884838129924AV Cardiovascular Suite V1Philips Medical Systems Nederland B.V.QIH2026-08-23
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07
04068151012453syngo.CT Coronary CockpitSiemens Healthcare GmbHQIH2026-07-17
04068151034202syngo DynamicsSiemens Healthineers AGQIH2026-07-16
00889024707092OrthoGrid®Orthogrid Systems, Inc.QIH2026-07-15
04068151086584LungMapsSiemens Healthineers AGQIH2026-06-24
03663999000429VEA AlignEOS IMAGINGQIH2026-06-12
04068151049923MI View&GOSIEMENS MEDICAL SOLUTIONS USA, INC.QIH2026-06-10
04068151018226syngo Application SoftwareSiemens Healthcare GmbHQIH2026-05-15
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00860013927820Overjet Iris Intelligent Imaging SystemOverjet, Inc.QIH2026-05-13
08437021722093ADAS 3DADAS3D MEDICAL S.L.QIH2026-05-12
00198715128956AngiowaveAngioWave Imaging, LLCQIH2026-05-09
07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.QIH2026-05-08
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06
B720BX360ECTA1430e-CTABRAINOMIX LIMITEDQIH2026-05-06