Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K130884 |
Device Name |
XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION |
Applicant |
GE MEDICAL SYSTEMS F.I. HAIFA |
4 HAYOZMA ST. |
TIRAT HACARMEL,
IL
30200
|
|
Applicant Contact |
ELI WERNER |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
NED DEVINE |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/29/2013 |
Decision Date | 04/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|