De Novo
DEN130012: FERRISCAN R2-MRI ANALYSIS SYSTEM
FDA De Novo · resonance health analysis services pty ltd · decided Jan 23, 2013
Key facts
| De Novo number | DEN130012 |
|---|---|
| Device name | FERRISCAN R2-MRI ANALYSIS SYSTEM |
| Applicant | resonance health analysis services pty ltd |
| Product code | PCS |
| Date received | Jan 2, 2013 |
| Decision date | Jan 23, 2013 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Radiology |
| FEI number | 3005450718 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: