PMA
P150043: QVCAD SYSTEM
FDA PMA · Analyzer, medical image · Qview Medical, Inc.
Key facts
| PMA number | P150043 |
|---|---|
| Trade name | QVCAD SYSTEM |
| Generic name | Analyzer, medical image |
| Applicant | Qview Medical, Inc. |
| Owner/operator | QView Medical, Inc. |
| Product code | MYN |
| Approval date | Nov 9, 2016 |
| Docket number | 16M-3914 |
| Notice date | Nov 16, 2016 |
| Establishment registration | 3012035824 |
| FEI number | 3012035824 |
At a glance
- 1–9 Supplements
- Dec 14, 2017 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- No Withdrawn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: