Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K043415 |
Device Name |
CENTRICITY PACS SYSTEM |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
800 BUSINESS CENTER DR. |
mount prospect,
IL
60056
|
|
Applicant Contact |
carol alloian |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
camas,
WA
98607 -9526
|
|
Correspondent Contact |
marc m mouser |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/13/2004 |
Decision Date | 01/21/2005 |
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
|
|
|