De Novo DEN130012
- Device
- FERRISCAN R2-MRI ANALYSIS SYSTEM
- Contact
- greg holland
- De Novo number
- DEN130012
- Product code
- PCS
- Regulation
- 892.1001
- Classification name
- liver iron concentration imaging companion diagnostic for deferasirox
- Decision
- granted (DENG)
- Decision date
- 2013-01-23
- Date received
- 2013-01-02
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- PCS
- Device name
- Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.1001
- Implant
- N
- Life sustain/support
- N