FDA-authorized DEN180005
OsteoDetect
Imagen Technologies, Inc.
Computer-aided detection/diagnosis
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- N/A
- Decision
- 2018-05-24
Vendor
Imagen Technologies, Inc.
6 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K193417
FractureDetect (FX)
Imagen Technologies, Inc.
Image analysis/processing for Bone using PET/SPECT/Nuclear Medicine.
- Modality
- PET/SPECT/Nuclear Medicine
- Anatomy
- Bone
- Decision
- 2020-07-30
FDA-cleared K210666
Chest-CAD
Imagen Technologies, Inc
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2021-07-20
FDA-cleared K213353
Aorta-CAD
Imagen Technologies, Inc
Image analysis/processing for Cardiovascular using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Cardiovascular
- Decision
- 2022-09-20
FDA-cleared K223811
Lung-CAD
Imagen Technologies, Inc
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2023-09-13
FDA-cleared K230085
Lung-CAD
Imagen Technologies, Inc
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2023-10-03