FDA-cleared K211431
breastscape v1.0
Olea Medical
Image analysis/processing for Breast using Mammography/DBT.
- Modality
- Mammography/DBT
- Anatomy
- Breast
- Decision
- 2021-08-02
Vendor
Olea Medical
3 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K223502
MR Diffusion Perfusion Mismatch V1.0
Olea Medical
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-01-13
FDA-cleared K230552
MR DWI/FLAIR Measurement V1.0
Olea Medical
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2023-04-26