FDA.report

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

Primary DI
08800045800342
Brand
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
Company
VUNO Inc.
Model
VN-M-30
Published
2024-11-19
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
true

Related Records

Product Codes

CodeName
QFMRadiological Computer-Assisted Prioritization Software For Lesions

Product Code Classifications

CodeDeviceSpecialtyClass
QFMRadiological Computer-Assisted Prioritization Software For LesionsRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800045800342PrimaryGS10

GMDN Terms

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

Regulatory Flags

DUNS number
694219059
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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 DIBrandModelCatalogPublished
08800045800106VUNO Med-DeepBrainVN-M-062023-12-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
G140ANNALISECONTAINER70Annalise TriageANNALISE-AI PTY LTDQFM2025-07-02
M722X25122P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
M722XC25114P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
M722XD25114P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-06-17
03770024774016SmartChestMILVUEQFM2025-03-31
M722X25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
M722XC25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
M722XD25064P250640ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2025-03-27
B826CINAVCF100CINA-VCFAVICENNA.AIQFM2024-06-20
M722XD24079P212210ClearRead Xray | PneumothoraxRiverain Technologies, Inc.QFM2024-04-15
08800076000179Lunit INSIGHT CXR TriageLunit Inc.QFM2024-04-09
00860006442668cmTriageCuremetrix, Inc.QFM2023-10-31
00850057636017qXR-PTX-PEQURE.AI TECHNOLOGIES PRIVATE LIMITEDQFM2023-10-10
00860007434709Cognet AIMedcognetics IncQFM2023-09-11
G140ANNALISEENTP30Annalise EnterpriseANNALISE-AI PTY LTDQFM2023-07-24
G140ANNALISEENTP20Annalise EnterpriseANNALISE-AI PTY LTDQFM2023-06-08
00811852030325Viz AAAVIZ.AI, INC.QFM2023-05-22
00811852030196Viz ANEURYSMVIZ.AI, INC.QFM2022-07-05
M722X22145P212210ClearRead Xray | PneumothoraxRiverain Technologies, Inc.QFM2022-07-05
M722XC22145P212210ClearRead Xray | PneumothoraxRiverain Technologies, Inc.QFM2022-07-05
M722XD22145P212210ClearRead Xray | PneumothoraxRiverain Technologies, Inc.QFM2022-07-05
00195278217981Critical Care SuiteGE MEDICAL SYSTEMS, INC.QFM2022-05-04
08800076000124Lunit INSIGHT CXR TriageLunit Inc.QFM2022-04-28
07290018016107HealthPPTZEBRA MEDICAL VISION LTDQFM2021-12-30
00860005144006Saige-QDeephealth, Inc.QFM2021-04-28
00840682147231Critical Care SuiteGE MEDICAL SYSTEMS, INC.QFM2020-11-23
07290018016060HealthMammoZEBRA MEDICAL VISION LTDQFM2020-09-21
07290018016084HealthVCFZEBRA MEDICAL VISION LTDQFM2020-09-21
07290018016077HealthPNXNANO-X AI LTDQFM2020-06-12
07290018016046HealthCXRZEBRA MEDICAL VISION LTDQFM2020-01-03