Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PhilipsLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list TomTec Imaging Systems with 23 510(k) clearances, 2 AI-enabled devices and 1 device recall. The most recent is a 510(k) clearance dated Jan 6, 2022: TOMTEC-ARENA.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jan 6, 2022 | TOMTEC-ARENAK213544 · QIH | 510(k) clearances |
| Jan 6, 2022 | TOMTEC-ARENAK213544 · Radiology | AI-enabled devices |
| Aug 14, 2020 | TOMTEC-ARENAK201632 · LLZ | 510(k) clearances |
| Aug 14, 2020 | TOMTEC-ARENAK201632 · Radiology | AI-enabled devices |
| Sep 23, 2019 | TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI:Class II · The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface f | Device recalls |
| Feb 13, 2015 | TOMTEC-ARENA TTA2K150122 · LLZ | 510(k) clearances |
| Nov 25, 2013 | TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENAK132544 · LLZ | 510(k) clearances |
| Oct 24, 2012 | IMAGE-COM 5.0K122289 · LLZ | 510(k) clearances |
| Apr 13, 2012 | 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0K120135 · LLZ | 510(k) clearances |
| May 24, 2011 | 4D LV-ANALYSIS 3.0K110746 · DQK | 510(k) clearances |
| Apr 8, 2011 | IMAGE-ARENA AND IMAGE-ARENA APPLICATIONSK110667 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
