Tomtec Imaging Systems GmbH - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
Denied
FDA 510(k) cleared devices by Tomtec Imaging Systems GmbH Radiology ✕
19 devices
Cleared
Jan 06, 2022
TOMTEC-ARENA
Radiology
59d
Cleared
Aug 14, 2020
TOMTEC-ARENA
Radiology
59d
Cleared
Feb 13, 2015
TOMTEC-ARENA TTA2
Radiology
24d
Cleared
Nov 25, 2013
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
Radiology
104d
Cleared
Oct 24, 2012
IMAGE-COM 5.0
Radiology
86d
Cleared
Apr 13, 2012
2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
Radiology
87d
Cleared
May 24, 2011
4D LV-ANALYSIS 3.0
Radiology
68d
Cleared
Apr 08, 2011
IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
Radiology
30d
Cleared
Apr 07, 2011
4D SONO-SCAN 1.0
Radiology
36d
Cleared
May 22, 2009
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
Radiology
88d
Cleared
Dec 23, 2008
IMAGE-ARENA APPLICATIONS
Radiology
40d
Cleared
Oct 01, 2008
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS...
Radiology
33d