Imagio® Breast Imaging system
FDA premarket approval P200003/S001 · decided 2022-06-17
Approval details
- PMA number
- P200003
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Imagio® Breast Imaging system
- Generic name
- Optoacoustic Imaging System
- Applicant
- Seno Medical Instruments, Inc.
- Date received
- 2021-11-01
- Decision date
- 2022-06-17
- Days to decision
- 228 days
- Decision code
- APPR
- Product code
- QNK
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- San Antonio, TX
- Statement
- Approval for the Imagio® Breast Imaging System. This device is indicated for use by a trained and qualified healthcare provider for evaluation ofpalpable and non-palpable breast abnormalities in adult patients who are referred for a diagnostic imaging breast work-up, following clinical presentation or either screening or diagnostic mammography or other imaging examinations. The ultrasound mode should be initially used in a targeted fashion, to assess any focal area(s) of clinical or imaging conc
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Imagio Ultrasound Imaging System (K182628) | Seno Medical Instruments, Inc. | 2019-03-05 |