Device Classification Name |
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
|
510(k) Number |
K103429 |
Device Name |
BIOGRAPH MMR |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA INC. |
810 INNOVATION DRIVE |
KNOXVILLE,
TN
37932
|
|
Applicant Contact |
ALAINE MEDIO |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA INC. |
810 INNOVATION DRIVE |
KNOXVILLE,
TN
37932
|
|
Correspondent Contact |
ALAINE MEDIO |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 11/22/2010 |
Decision Date | 06/08/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|