Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K122034 |
Device Name |
MRJ 3300 |
Applicant |
PARAMED SRL |
CORSO F.M. PERRONE 73R |
GENOA,
IT
16152
|
|
Applicant Contact |
LUISELLA DEBENEDETTI |
Correspondent |
PARAMED SRL |
CORSO F.M. PERRONE 73R |
GENOA,
IT
16152
|
|
Correspondent Contact |
LUISELLA DEBENEDETTI |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 07/11/2012 |
Decision Date | 12/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|