Device Classification Name |
liver iron concentration imaging companion diagnostic for deferasirox
|
De Novo Number |
DEN130012 |
510(K) Number |
K124065
|
Device Name |
FERRISCAN R2-MRI ANALYSIS SYSTEM |
Requester |
resonance health analysis services pty ltd |
3722 ave. sausalito |
irvine,
CA
92606
|
|
Contact |
greg holland |
|
Regulation Number | 892.1001
|
Classification Product Code |
|
Date Received | 01/02/2013 |
Decision Date | 01/23/2013 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Radiology
|
Review Advisory Committee |
Radiology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|