Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K071964 |
Device Name |
MIM 4.1 (SEASTAR) |
Applicant |
MIMVISTA CORP. |
25200 CHAGRIN BLVD. SUITE 200 |
CLEVELAND,
OH
44122
|
|
Applicant Contact |
PETER SIMMELINK |
Correspondent |
MIMVISTA CORP. |
25200 CHAGRIN BLVD. SUITE 200 |
CLEVELAND,
OH
44122
|
|
Correspondent Contact |
PETER SIMMELINK |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 07/16/2007 |
Decision Date | 09/26/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|