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510(k) K071232

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2007
Date Received
May 3, 2007
Clearance Type
Special
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)

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