Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K090461 |
Device Name |
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 |
Applicant |
TOMTEC IMAGING SYSTEMS, GMBH |
EDISONSTRASSE 6 |
UNTERSCHLEISSHEIM,
DE
D-85716
|
|
Applicant Contact |
INGE SCHEIDT |
Correspondent |
TOMTEC IMAGING SYSTEMS, GMBH |
EDISONSTRASSE 6 |
UNTERSCHLEISSHEIM,
DE
D-85716
|
|
Correspondent Contact |
INGE SCHEIDT |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/23/2009 |
Decision Date | 05/22/2009 |
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
|
|
|