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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 14 Results
ProductCode: LLZ Applicant: TOMTEC IMAGING SYSTEMS, GMBH Decision Date To: 05/04/2024
 
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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
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