PMA supplement
P200003 S001: Imagio® Breast Imaging system
FDA PMA supplement · Normal 180 Day Track · Seno Medical Instruments, Inc.
Key facts
| Original PMA | P200003 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Imagio® Breast Imaging system |
| Generic name | Optoacoustic Imaging System |
| Applicant | Seno Medical Instruments, Inc. |
| Product code | QNK |
| Received date | Nov 1, 2021 |
| Decision date | Jun 17, 2022 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: