FDA-approved P160009
PowerLook® Tomo Detection Software
iCAD Inc
Image analysis/processing
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- N/A
- Decision
- 2017-03-24
Vendor
iCAD Inc
6 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K182373
PowerLook Tomo Detection V2 Software
iCAD Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2018-12-06
FDA-cleared K191994
ProFound AI Software V2.1
iCAD Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2019-10-04
FDA-cleared K203822
ProFound AI Software V3.0
iCAD Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2021-03-12
FDA-cleared K211506
PowerLook Density Assessment V4.0
iCAD, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2021-07-12
FDA-cleared K240417
ProFound Detection (V4.0)
iCAD, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2024-11-08