Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K072986 |
Device Name |
INTEGRADWEB PACS SYSTEM |
Applicant |
GE HEALTHCARE |
25 WALNUT STREET |
MONROE,
CT
06468
|
|
Applicant Contact |
JILLIAN M REED |
Correspondent |
GE HEALTHCARE |
25 WALNUT STREET |
MONROE,
CT
06468
|
|
Correspondent Contact |
JILLIAN M REED |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 10/23/2007 |
Decision Date | 11/20/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|