Device Classification Name |
System, Nuclear Magnetic Resonance Imaging
|
510(k) Number |
K110802 |
Device Name |
A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 |
Applicant |
ESAOTE S.P.A. |
11460 N MERIDIAN ST |
SUITE 150 |
CARMEL,
IN
46032
|
|
Applicant Contact |
Allison Scott |
Correspondent |
ESAOTE S.P.A. |
11460 N MERIDIAN ST |
SUITE 150 |
CARMEL,
IN
46032
|
|
Correspondent Contact |
Allison Scott |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 03/23/2011 |
Decision Date | 04/08/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|