FDA.reportPublic FDA data

e-Lung

Primary DI
B720BX360ELUNG210
Brand
e-Lung
Company
BRAINOMIX LIMITED
Model
2.1
Published
2025-04-15
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
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242411000Brainomix 360 e-LungBrainomix Limited2025-02-19JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B720BX360ELUNG210PrimaryHIBCC0

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].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
216967482
Device count
1

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
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
08800025300299AVIEWCORELINE SOFT CO.,LTD.JAK2025-03-27
08800025300367AVIEW CACCORELINE SOFT CO.,LTD.JAK2025-03-24
00850025268318Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-03-21
00850025268325Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-11-21
00850025268301Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-20
00850025268257Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-09-05
00850025268295Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-08-13
10884521837102ILLUMISITECovidien LPJAK2024-08-09
10884521837126ILLUMISITECovidien LPJAK2024-08-09
10884521837133ILLUMISITECovidien LPJAK2024-08-09
10884521837140ILLUMISITECovidien LPJAK2024-08-09
10884521837157ILLUMISITECovidien LPJAK2024-08-09
10884521842915ILLUMISITECovidien LPJAK2024-08-09
07640167220021CAS-One IR Consumable Set GeneralCAScination AGJAK2024-06-17
00850025268240Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-05-02
08800025300237AVIEW CACCORELINE SOFT CO.,LTD.JAK2024-04-25
00850025268233Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-04-12
00850025268226Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2024-01-29