Device Classification Name |
System, Tomography, Computed, Emission
|
510(k) Number |
K942146 |
Device Name |
PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER |
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 | 09/23/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|