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510(k) K933916

AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER by Ausonics Pty , Ltd. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1994
Date Received
August 11, 1993
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 Ausonics Pty , Ltd.

  • K915715 — CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER (July 2, 1992)
  • K920307 — AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION (May 19, 1992)
  • K905488 — DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN (December 18, 1991)
  • K902728 — 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) (February 13, 1991)
  • K896714 — AUSONICS 5000 (June 11, 1990)
  • K881979 — RESUBMITTAL OF MI 1000C MICROIMAGER (June 12, 1989)
  • K884299 — APA-C CATALOG NUMBER A-8001-C (January 10, 1989)
  • K883925 — UROIMAGER (December 15, 1988)
  • K883079 — WWDS-005 HUMAN RECTAL PROBE (December 14, 1988)
  • K883372 — ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT (November 25, 1988)

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