Radiology
Imagio Breast Imaging System
Seno Medical Instruments, Inc.
FDA-cleared AI medical device
The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis
FDA Submission Metadata
- Submission number
- P200003
- Decision date
- January 2021
- FDA panel
- Radiology
- Product code
- QNK
- Clinical task (npj)
- diagnosis
- Data modality (npj)
- Images
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.