Device Classification Name |
Coil, Magnetic Resonance, Specialty
|
510(k) Number |
K012728 |
Device Name |
E-SCAN MRI SYSTEM |
Applicant |
BIOSOUND ESAOTE, INC. |
8000 CASTLEWAY DR. |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
COLLEEN HITTLE |
Correspondent |
BIOSOUND ESAOTE, INC. |
8000 CASTLEWAY DR. |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
COLLEEN HITTLE |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 08/15/2001 |
Decision Date | 08/29/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|