FDA-cleared K260320

Lunit INSIGHT MMG (v1.1.10)

Lunit, Inc.

Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2026-04-23
FDA-cleared K253796

Lunit INSIGHT DBT (V1.2)

Lunit, Inc.

Concurrent CADe/x aid for interpreting physicians to detect and characterize breast-cancer-suspicious lesions in screening DBT exams from compatible systems, marking soft-tissue...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2026-03-26
FDA-cleared K242652

Lunit INSIGHT DBT v1.1

Lunit Inc.

Concurrent CADe/x aid for interpreting physicians to detect and characterize breast-cancer-suspicious lesions in screening DBT exams from compatible systems.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2024-10-04
FDA-cleared K231470

Lunit INSIGHT DBT

Lunit Inc.

Concurrent CADe/x aid for interpreting physicians to detect and characterize suspected breast-cancer lesions in screening DBT exams from compatible systems.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2023-11-06
FDA-cleared K211678

Lunit INSIGHT MMG

Lunit Inc.

Aid interpreting physicians in detecting, localizing, and characterizing suspicious breast-cancer areas on mammograms from compatible FFDM systems, viewed after the physician...

Modality
Mammography/DBT
Anatomy
Breast.
Decision
2021-11-17
FDA-cleared K211733

Lunit INSIGHT CXR Triage

Lunit Inc.

Lunit INSIGHT CXR Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2021-11-10