Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K093982 |
Device Name |
XELERIS 3 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. |
1285 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
CASEY CONRY |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/24/2009 |
Decision Date | 01/08/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|