FDA.reportPublic FDA data

Lunit INSIGHT CXR Triage

Primary DI
08800076000179
Brand
Lunit INSIGHT CXR Triage
Company
Lunit Inc.
Model
1.0
Device description
Lunit INSIGHT CXR Triage - Windows version
Published
2024-04-09
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
QFMRadiological Computer-Assisted Prioritization Software For Lesions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFMRadiological Computer-Assisted Prioritization Software For LesionsRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211733000Lunit INSIGHT CXR TriageLunit, Inc.2021-11-10QFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800076000179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800076000179088000760001798800076000179

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
690102406
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800076000056Lunit INSIGHT MMG1.12022-04-28
08800076000230Lunit INSIGHT DBT1.22026-04-17
08800076000162Lunit INSIGHT DBT1.12024-04-09
08800076000124Lunit INSIGHT CXR Triage1.02022-04-28
08800076000148Lunit INSIGHT DBT1.02023-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007434716Cognet AIMedcognetics IncQFM2026-05-21
07290018052365BriefCase TriageAIDOC MEDICAL LTDQFM2026-02-15
G140ANNALISECONTAINER60Annalise Critical Care AIHARRISON-AI MEDICAL PTY LTDQFM2025-07-28
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2025-07-24
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL 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
B761R60Rapid Ischemaview, Inc.QFM2025-05-07
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
07290018052273BriefCase TriageAIDOC MEDICAL LTDQFM2024-11-24
07290018052297BriefCase TriageAIDOC MEDICAL LTDQFM2024-11-24
08800045800342VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVUNO Inc.QFM2024-11-19
B826CINAVCF100CINA-VCFAVICENNA.AIQFM2024-06-20
M722XD24079P212210ClearRead Xray PneumothoraxRiverain Technologies, Inc.QFM2024-04-15
B761R51020RapidIschemaview, Inc.QFM2024-02-13
B761R610RapidIschemaview, Inc.QFM2024-02-13
G140ANNALISEENTP50Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2024-01-11
07290018052259BriefCase TriageAIDOC MEDICAL LTDQFM2023-12-27
G140ANNALISEENTP40Annalise TriageHARRISON-AI MEDICAL PTY LTDQFM2023-11-06
00860006442668cmTriageCuremetrix, Inc.QFM2023-10-31
00850057636017qXR-PTX-PEQURE.AI TECHNOLOGIES PRIVATE LIMITEDQFM2023-10-10
00860007434709Cognet AIMedcognetics IncQFM2023-09-11
G140ANNALISEENTP30Annalise EnterpriseHARRISON-AI MEDICAL PTY LTDQFM2023-07-24
07290018052211BriefCase TriageAIDOC MEDICAL LTDQFM2023-07-14
G140ANNALISEENTP20Annalise EnterpriseHARRISON-AI MEDICAL PTY LTDQFM2023-06-08
00811852030325Viz AAAVIZ.AI, INC.QFM2023-05-22