FDA-cleared K211733
Lunit INSIGHT CXR Triage
Lunit Inc.
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2021-11-10
Vendor
Lunit Inc.
4 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K211678
Lunit INSIGHT MMG
Lunit Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2021-11-17
FDA-cleared K231470
Lunit INSIGHT DBT
Lunit Inc.
Image analysis/processing for Breast using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2023-11-06
FDA-cleared K242652
Lunit INSIGHT DBT v1.1
Lunit Inc.
Image analysis/processing for Breast using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2024-10-04