Device Classification Name |
system, nuclear magnetic resonance imaging
|
510(k) Number |
K052305 |
Device Name |
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
45 STILES ROAD |
SALEM,
NH
03079
|
|
Applicant Contact |
BARRY V ASHAR |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
LAURA DANIELSON |
Regulation Number | 892.1000
|
Classification Product Code |
|
Date Received | 08/24/2005 |
Decision Date | 09/08/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|