PMA
P050022: SYNGO LUNG CAD
FDA PMA · Lung computed tomography system, computer-aided diagnosis · Siemens Medical Solutions USA, Inc.
Key facts
| PMA number | P050022 |
|---|---|
| Trade name | SYNGO LUNG CAD |
| Generic name | Lung computed tomography system, computer-aided diagnosis |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Owner/operator | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Product code | NRR |
| Approval date | Oct 18, 2006 |
| Docket number | 06M-0456 |
| Notice date | Nov 8, 2006 |
| Establishment registration | 2240869 |
| FEI number | 2240869 |
At a glance
- None Supplements
- Oct 18, 2006 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: