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510(k) K973079

L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM by Acuson Corp. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1997
Date Received
August 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Acuson Corp.

  • K023772 — KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM (November 22, 2002)
  • K022896 — CSV12 SOFTWARE VIEWER (October 3, 2002)
  • K022567 — SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM (August 13, 2002)
  • K021497 — CYPRESS ULTRASOUND SYSTEM (July 9, 2002)
  • K010950 — CYPRESS SYSTEM (June 27, 2001)
  • K002807 — 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING (December 1, 2000)
  • K992631 — ACUNAV DIAGNOSTIC ULTRASOUND CATHETER (December 15, 1999)
  • K992580 — FETAL ASSESSMENT CAP (October 18, 1999)
  • K991805 — ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION (August 2, 1999)
  • K973767 — HARMONIC IMAGING WITH CONTRAST (December 23, 1997)

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