PMA
P130025: KONING BREAST CT (MODEL CBCT1000)
FDA PMA · Cross-sectional mammographic xray system · Koning Corporation
Key facts
| PMA number | P130025 |
|---|---|
| Trade name | KONING BREAST CT (MODEL CBCT1000) |
| Generic name | Cross-sectional mammographic xray system |
| Applicant | Koning Corporation |
| Owner/operator | Koning Corporation |
| Product code | OLQ |
| Approval date | Jan 14, 2015 |
| Docket number | 15M-0200 |
| Notice date | Feb 9, 2015 |
| Establishment registration | 3008513054 |
| FEI number | 3008513054 |
At a glance
- 1–9 Supplements
- Oct 12, 2023 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- No Withdrawn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: