PMA
P200003: Imagio Breast Imaging System
FDA PMA · Optoacoustic Imaging System · Seno Medical Instruments, Inc.
Key facts
| PMA number | P200003 |
|---|---|
| Trade name | Imagio Breast Imaging System |
| Generic name | Optoacoustic Imaging System |
| Applicant | Seno Medical Instruments, Inc. |
| Owner/operator | Seno Medical Instruments, Inc. |
| Product code | QNK |
| Approval date | Jan 11, 2021 |
| Docket number | 21M-0070 |
| Notice date | Jan 13, 2021 |
| Establishment registration | 3014755924 |
| FEI number | 3014755924 |
At a glance
- 1–9 Supplements
- Jun 17, 2022 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: