|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
tomtec-arena tta2
|
TOMTEC IMAGING SYSTEMS, GMBH
|
K150122 |
02/13/2015
|
tomtec-arena 1.0, tomtec-arena 3d echo, cardio-arena
|
TOMTEC IMAGING SYSTEMS, GMBH
|
K132544 |
11/25/2013
|
2d cardiac performance analysis mr 1.0
|
TOMTEC IMAGING SYSTEMS, GMBH
|
K120135 |
04/13/2012
|
4d lv-analysis 3.0
|
TOMTEC IMAGING SYSTEMS, GMBH
|
K110746 |
05/24/2011
|
image-arena and image-arena applications
|
TOMTEC IMAGING SYSTEMS, GMBH
|
K110667 |
04/08/2011
|
4d sono-scan 1.0
|
TOMTEC IMAGING SYSTEMS, GMBH
|
K110595 |
04/07/2011
|
image-arena 4.0 and ia applications 2d cardiac performance analysis 1.0
|
TOMTEC IMAGING SYSTEMS, GMBH
|
K090461 |
05/22/2009
|
image-arena applications
|
TOMTEC IMAGING SYSTEMS, GMBH
|
K083348 |
12/23/2008
|
image-arena applications, model image-arena va platform 1.0, 4d lv-analysis 2.5, 4d lv-analysis mr 1.0
|
TOMTEC IMAGING SYSTEMS, GMBH
|
K082510 |
10/01/2008
|
image-arena applications and research-arena applications
|
TOMTEC IMAGING SYSTEMS, GMBH
|
K071232 |
06/20/2007
|