Device Classification Name |
system, digital image communications, radiological
|
510(k) Number |
K923582 |
Device Name |
SIENET CAMERA SERVER |
Applicant |
SIEMENS GAMMASONICS, INC. |
2501 N. BARRINGTON RD. |
HOFFMAN ESTATES,
IL
60195 -7372
|
|
Applicant Contact |
IRENA KRUTULIS |
Correspondent |
SIEMENS GAMMASONICS, INC. |
2501 N. BARRINGTON RD. |
HOFFMAN ESTATES,
IL
60195 -7372
|
|
Correspondent Contact |
IRENA KRUTULIS |
Regulation Number | 892.2020
|
Classification Product Code |
|
Date Received | 07/20/1992 |
Decision Date | 10/14/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|