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510(k) K003936

PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING by Tomtec Imaging Systems GmbH — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2001
Date Received
December 20, 2000
Clearance Type
Traditional
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

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  • 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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