Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Tomtec Imaging Systems GmbH — Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

52 daysmedian FDA review time
87 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213544TOMTEC-ARENATomtec Imaging Systems GmbH2022-01-06590
K201632TOMTEC-ARENATomtec Imaging Systems GmbH2020-08-14590
K150122TOMTEC-ARENA TTA2Tomtec Imaging Systems GmbH2015-02-13240
K132544TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENATomtec Imaging Systems GmbH2013-11-251040
K122289IMAGE-COM 5.0Tomtec Imaging Systems GmbH2012-10-24860
K1201352D CARDIAC PERFORMANCE ANALYSIS MR 1.0Tomtec Imaging Systems GmbH2012-04-13870
K1107464D LV-ANALYSIS 3.0Tomtec Imaging Systems GmbH2011-05-24680
K110667IMAGE-ARENA AND IMAGE-ARENA APPLICATIONSTomtec Imaging Systems GmbH2011-04-08300
K1105954D SONO-SCAN 1.0Tomtec Imaging Systems GmbH2011-04-07360
K1037824D MV-ASSESSMENT 2.0Tomtec Imaging Systems GmbH2011-01-27310
K090461IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ATomtec Imaging Systems GmbH2009-05-22881
K083348IMAGE-ARENA APPLICATIONSTomtec Imaging Systems GmbH2008-12-23400
K082510IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0,Tomtec Imaging Systems GmbH2008-10-01330
K071232IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONSTomtec Imaging Systems GmbH2007-06-20480
K040546IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONSTomtec Imaging Systems GmbH2004-04-27560
K022824ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.XTomtec Imaging Systems GmbH2002-10-17520
K020561SONO-SCAN, SONO-SCAN PRO, CARDIO SCANTomtec Imaging Systems GmbH2002-05-09780
K003936PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNINGTomtec Imaging Systems GmbH2001-02-14560
K001592ECHOCOM, IMAGECOM, DOKUCOMTomtec Imaging Systems GmbH2000-06-16240
K993398ECHO VIEW, EASY VIEW, OMNI VIEWTomtec Imaging Systems GmbH1999-11-05280
K993394ECHO SCAN, EASY SCANTomtec Imaging Systems GmbH1999-11-05280

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda