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510(k) K920307

AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION by Ausonics Pty , Ltd. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1992
Date Received
January 23, 1992
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 Ausonics Pty , Ltd.

  • K933916 — AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER (October 3, 1994)
  • K915715 — CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER (July 2, 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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