Device Classification Name |
system, tomography, computed, emission
|
510(k) Number |
K942145 |
Device Name |
NON-UNIFORM ATTENUATION CORRECTION SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ROENTGEN ANGIOGRAPHY CHICAGO |
2501 N. BARRINGTON ROAD |
HOFFMAN ESTATES,
IL
60195 -7372
|
|
Applicant Contact |
IRENA KRUTULIS |
Correspondent |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ROENTGEN ANGIOGRAPHY CHICAGO |
2501 N. BARRINGTON ROAD |
HOFFMAN ESTATES,
IL
60195 -7372
|
|
Correspondent Contact |
IRENA KRUTULIS |
Regulation Number | 892.1200
|
Classification Product Code |
|
Date Received | 05/03/1994 |
Decision Date | 02/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|