Imagio Ultrasound Imaging System
FDA 510(k) clearance K182628 · decided 2019-03-05
Clearance details
- K-number
- K182628
- Device name
- Imagio Ultrasound Imaging System
- Applicant
- Seno Medical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-09-24
- Decision date
- 2019-03-05
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Imagio® Breast Imaging system (P200003/S001) | Seno Medical Instruments, Inc. | 2022-06-17 |
| Imagio Breast Imaging System (P200003) | Seno Medical Instruments, Inc. | 2021-01-11 |