Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K042525 |
Device Name |
CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
800 BUSINESS CENTER DR. |
MOUNT PROSPECT,
IL
60056
|
|
Applicant Contact |
CAROL ALLOIAN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
333 PFINGSTEN RD. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
CHANTEL CARSON |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/17/2004 |
Decision Date | 10/01/2004 |
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
|
|
|