Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K182290 |
Device Name |
IBM iConnect Access |
Applicant |
Merge Healthcare Incorporated |
900 Walnut Ridge Drive |
Hartland,
WI
53209
|
|
Applicant Contact |
Tracey Fox |
Correspondent |
Merge Healthcare Incorporated |
900 Walnut Ridge Drive |
Hartland,
WI
53209
|
|
Correspondent Contact |
Tracey Fox |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 08/23/2018 |
Decision Date | 09/25/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|