Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K122006 |
Device Name |
G-SCAN BRIO |
Applicant |
ESAOTE, S.P.A. |
9001 Wesleyan Road |
Suite 200 |
Indianapolis,
IN
46268
|
|
Applicant Contact |
ALLISON SCOTT, RAC |
Correspondent |
ESAOTE, S.P.A. |
9001 Wesleyan Road |
Suite 200 |
Indianapolis,
IN
46268
|
|
Correspondent Contact |
ALLISON SCOTT, RAC |
Regulation Number | 892.1000
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/09/2012 |
Decision Date | 08/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|