Home / 510(k) Clearances / K090461

510(k) K090461

IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 by Tomtec Imaging Systems GmbH — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2009
Date Received
February 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Tomtec Imaging Systems GmbH

  • K213544 — TOMTEC-ARENA (January 6, 2022)
  • K201632 — TOMTEC-ARENA (August 14, 2020)
  • K150122 — TOMTEC-ARENA TTA2 (February 13, 2015)
  • K132544 — TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA (November 25, 2013)
  • K122289 — IMAGE-COM 5.0 (October 24, 2012)
  • K120135 — 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0 (April 13, 2012)
  • K110746 — 4D LV-ANALYSIS 3.0 (May 24, 2011)
  • K110667 — IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS (April 8, 2011)
  • K110595 — 4D SONO-SCAN 1.0 (April 7, 2011)
  • K103782 — 4D MV-ASSESSMENT 2.0 (January 27, 2011)

Other clearances for product code LLZ

  • K260479 — TheraSphere 360™ Y-90 Management Platform (March 13, 2026)
  • K253111 — Aeka Imaging (March 13, 2026)
  • K251964 — Mimics Thoracic Planner (March 12, 2026)
  • K253551 — VELYS™ Hip Navigation (March 6, 2026)
  • K253486 — SKIA-Head (Model: SKIA-ST00) (February 23, 2026)
  • K260205 — AS Software Version Asera (February 19, 2026)
  • K253927 — LiveMedica Enterprise PACS (February 6, 2026)
  • K251577 — LAIA XR (February 6, 2026)
  • K253639 — View (January 8, 2026)
  • K253784 — 3DICOM MD Cloud (January 8, 2026)