FDA.reportPublic FDA data

Brainomix 360 e-CTA

Primary DI
B720BX360ECTA1210
Brand
Brainomix 360 e-CTA
Company
BRAINOMIX LIMITED
Model
12.1
Published
2026-03-30
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
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B720BX360ECTA1210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
X-ray image interpretive softwareAn interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].

Regulatory Flags#

DUNS number
216967482
Device count
1
Lot or batch
true
Manufacturing date on label
true

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
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
B720BX360ECTP1200e-CTP12.02025-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.QIH2026-05-12
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.QIH2026-05-08
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800124700136SwiftMRAIRS Medical Inc.QIH2026-04-01
G703AIORTAPLAN0AiORTA - PlanVitaa Medical Solutions Inc.QIH2026-03-30
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200626MEDIHUB PROSTATEJLK, Inc.QIH2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
10603295562108VELYS Hip NavigationDEPUY ORTHOPAEDICS, INC.QIH2026-03-24
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.QIH2026-02-24