PMA
P200040: SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
FDA PMA · Automated breast ultrasound · Delphinus Medical Technologies
Key facts
| PMA number | P200040 |
|---|---|
| Trade name | SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly |
| Generic name | Automated breast ultrasound |
| Applicant | Delphinus Medical Technologies |
| Owner/operator | AB Medical Technologies, Inc. |
| Product code | PAA |
| Approval date | Oct 6, 2021 |
| Docket number | 21M-1352 |
| Notice date | Dec 23, 2021 |
| Establishment registration | 3010356635 |
| FEI number | 1000123848 |
At a glance
- 1–9 Supplements
- Apr 11, 2024 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- No Withdrawn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: