Home / 510(k) Clearances / K110667

510(k) K110667

IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS by Tomtec Imaging Systems GmbH — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2011
Date Received
March 9, 2011
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)
  • K110595 — 4D SONO-SCAN 1.0 (April 7, 2011)
  • K103782 — 4D MV-ASSESSMENT 2.0 (January 27, 2011)
  • K090461 — IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 (May 22, 2009)

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)