FDA-approved P200003
Imagio Breast Imaging System
Seno Medical Instruments, Inc.
Computer-aided detection/diagnosis
- Modality
- Modality not specified in FDA list
- Anatomy
- Breast
- Decision
- 2021-01-11
Modality
Modality not specified in FDA list radiology AI tools
3 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
FDA-authorized DEN230023
Rho
16 Bit Inc
Computer-aided detection/diagnosis
- Modality
- Modality not specified in FDA list
- Anatomy
- N/A
- Decision
- 2024-04-09
FDA-authorized DEN240047
Allix5
Clairity, Inc.
Computer-aided detection/diagnosis
- Modality
- Modality not specified in FDA list
- Anatomy
- N/A
- Decision
- 2025-05-30