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Tomtec Imaging Systems GmbH

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K213544 TOMTEC-ARENAQIH2022-01-06 View
510(k) K201632 TOMTEC-ARENALLZ2020-08-14 View
510(k) K132544 TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENALLZ2013-11-25 View
510(k) K122289 IMAGE-COM 5.0LLZ2012-10-24 View
510(k) K120135 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0LLZ2012-04-13 View
510(k) K110746 4D LV-ANALYSIS 3.0DQK2011-05-24 View
510(k) K110667 IMAGE-ARENA AND IMAGE-ARENA APPLICATIONSLLZ2011-04-08 View
510(k) K110595 4D SONO-SCAN 1.0LLZ2011-04-07 View
510(k) K103782 4D MV-ASSESSMENT 2.0DQK2011-01-27 View
510(k) K090461 IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0LLZ2009-05-22 View
510(k) K083348 IMAGE-ARENA APPLICATIONSLLZ2008-12-23 View
510(k) K082510 IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0LLZ2008-10-01 View
510(k) K071232 IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONSLLZ2007-06-20 View
510(k) K040546 IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONSLLZ2004-04-27 View
510(k) K022824 ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.XLLZ2002-10-17 View
510(k) K020561 SONO-SCAN, SONO-SCAN PRO, CARDIO SCANIYO2002-05-09 View
510(k) K003936 PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNINGIYO2001-02-14 View
510(k) K001592 ECHOCOM, IMAGECOM, DOKUCOMDQK2000-06-16 View
510(k) K993394 ECHO SCAN, EASY SCANIYO1999-11-05 View
510(k) K993398 ECHO VIEW, EASY VIEW, OMNI VIEWIYO1999-11-05 View
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