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510(k) K020561

SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN by Tomtec Imaging Systems GmbH — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2002
Date Received
February 20, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Tomtec Imaging Systems GmbH

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  • 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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