PMA
P030012: IMAGECHECKER CT CAD SOFTWARE SYSTEM
FDA PMA · Lung computed tomography system, computer-aided diagnosis · Hologic, Inc.
Key facts
| PMA number | P030012 |
|---|---|
| Trade name | IMAGECHECKER CT CAD SOFTWARE SYSTEM |
| Generic name | Lung computed tomography system, computer-aided diagnosis |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | NRR |
| Approval date | Jul 8, 2004 |
| Docket number | 04M-0323 |
| Notice date | Jul 22, 2004 |
| Establishment registration | 1222780 |
| FEI number | 1000120743 |
At a glance
- None Supplements
- Jul 8, 2004 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- No Withdrawn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: