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510(k) K103782

4D MV-ASSESSMENT 2.0 by Tomtec Imaging Systems GmbH — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2011
Date Received
December 27, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Tomtec Imaging Systems GmbH

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  • 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)
  • K090461 — IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0 (May 22, 2009)

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