Device Classification Name |
system, digital image communications, radiological
|
510(k) Number |
K920310 |
Device Name |
SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE |
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 | 01/23/1992 |
Decision Date | 03/30/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|