510(k) DEN130012
- Device
- FERRISCAN R2-MRI ANALYSIS SYSTEM
- Applicant
- Resonance Health Analysis Services Pty, Ltd.
- 510(k) number
- DEN130012
- Product code
- PCS
- Decision
- Unknown (DENG)
- Decision date
- 2013-01-23
- Date received
- 2013-01-02
- Regulation
- 892.1001
- Classification name
- Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- GREG HOLLAND
- Address
- 3722 Ave. Sausalito Irvine CA US 92606 92606
FDA Registration Numbers#
- 3005450718
Source Documents#
510(k) summary PDF not indicated by FDA