FDA.reportPublic FDA data

Lunit INSIGHT DBT

Primary DI
08800076000162
Brand
Lunit INSIGHT DBT
Company
Lunit Inc.
Model
1.1
Published
2024-04-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDQRadiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For CancerRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231470000
K242652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231470000Lunit INSIGHT DBTLunit, Inc.2023-11-06QDQ
K242652000Lunit INSIGHT DBT v1.1Lunit, Inc.2024-10-04QDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800076000162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800076000162088000760001628800076000162

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
Lot or batch
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
08800076000179Lunit INSIGHT CXR Triage1.02024-04-09
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
08800076000230Lunit INSIGHT DBTLunit Inc.QDQ2026-04-17
00850008977541ProFound DetectionIcad, Inc.QDQ2026-03-23
08437021468236QP-Prostate® CADQUIBIM SOCIEDAD LIMITADA.QDQ2026-03-06
08437021468168QP-Prostate® CADQUIBIM SOCIEDAD LIMITADA.QDQ2025-05-02
08437021468120QP-Prostate® CADQUIBIM SOCIEDAD LIMITADA.QDQ2025-03-28
08720387058051TransparaScreenpoint Medical B.V.QDQ2024-11-28
00860006305727See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QDQ2024-11-22
08800076000148Lunit INSIGHT DBTLunit Inc.QDQ2023-12-01
00860009082601Bot Image, Inc.Bot Image, Inc.QDQ2023-03-17
00860009082625Bot Image, Inc.Bot Image, Inc.QDQ2023-03-17
08720387058013TransparaScreenpoint Medical B.V.QDQ2023-03-03
00860009082618Bot Image, Inc.Bot Image, Inc.QDQ2023-01-11
00860005144013Saige-DxDeephealth, Inc.QDQ2022-05-26
08800076000056Lunit INSIGHT MMGLunit Inc.QDQ2022-04-28
B885MAML2US0MammoScreenTHERAPIXELQDQ2022-01-20
08719326450131TransparaScreenpoint Medical B.V.QDQ2021-07-23
00850008977176ProFound AI V3.0Icad, Inc.QDQ2021-05-17
B885MAML0MammoScreenTHERAPIXELQDQ2020-06-23
08719326450117TransparaScreenpoint Medical B.V.QDQ2020-03-16
08719326450124TransparaScreenpoint Medical B.V.QDQ2019-12-12
00858012005960ProFound AIIcad, Inc.QDQ2019-07-11
08719326450100TransparaScreenpoint Medical B.V.QDQ2019-02-04
00858012005939PowerLook Tomo Detection (ProFound AI)Icad, Inc.QDQ2018-12-27