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510(k) K980468

AU5 ULTRASOUND IMAGING SYSTEM by Biosound Esaote, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1998
Date Received
February 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Biosound Esaote, Inc.

  • K023255 — TECHNOS MP, MODEL AU6 (February 11, 2003)
  • K014168 — AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE (April 25, 2002)
  • K020164 — E-SCAN XQ (February 12, 2002)
  • K012728 — E-SCAN MRI SYSTEM (August 29, 2001)
  • K010405 — 7230 ULTRASOUND IMAGING SYSTEM WITH TEI (March 13, 2001)
  • K010057 — MODIFICATION TO ARTOSCAN M (February 2, 2001)
  • K001894 — MODIFICATION TO E-SCAN (July 6, 2000)
  • K000931 — AU5 ULTRASOUND IMAGING SYSTEM (June 8, 2000)
  • K000681 — AU5, AU6 (May 3, 2000)
  • K994369 — 7250 (MEGAS) (February 24, 2000)

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