Skip to contentDe Novo DEN100016
- Device
- PROSTATE MECHANICAL IMAGER
- Contact
- gerard j prud'homme
- De Novo number
- DEN100016
- Product code
- OQT
- Regulation
- 876.2050
- Classification name
- prostate lesion, documentation, system
- Decision
- granted (DENG)
- Decision date
- 2012-04-27
- Date received
- 2010-05-21
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OQT
- Device name
- Prostate Lesion, Documentation, System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.2050
- Implant
- N
- Life sustain/support
- N