Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K121650 |
Device Name |
S-SCAN |
Applicant |
ESAOTE, S.P.A. |
9001 Wesleyan Road |
Suite 200 |
Indianapolis,
IN
46268
|
|
Applicant Contact |
Allison Scott |
Correspondent |
ESAOTE, S.P.A. |
9001 Wesleyan Road |
Suite 200 |
Indianapolis,
IN
46268
|
|
Correspondent Contact |
Allison Scott |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 06/05/2012 |
Decision Date | 07/09/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|