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510(k) K023772

KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM by Acuson Corp. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2002
Date Received
November 12, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • 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)
  • K973079 — L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM (November 5, 1997)

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