De Novo
DEN100016: PROSTATE MECHANICAL IMAGER
FDA De Novo · artann laboratories, inc · decided Apr 27, 2012
Key facts
| De Novo number | DEN100016 |
|---|---|
| Device name | PROSTATE MECHANICAL IMAGER |
| Applicant | artann laboratories, inc |
| Product code | OQT |
| Date received | May 21, 2010 |
| Decision date | Apr 27, 2012 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Gastroenterology & Urology |
At a glance
- None 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: