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510(k) K881979

RESUBMITTAL OF MI 1000C MICROIMAGER by Ausonics Pty , Ltd. — Product Code JOP

K881979 is an FDA 510(k) premarket notification submitted by Ausonics Pty , Ltd. for the device "RESUBMITTAL OF MI 1000C MICROIMAGER". The FDA issued a decision of Substantially Equivalent on June 12, 1989. The device falls under product code JOP (Transducer, Ultrasonic), a Class II device regulated under 21 CFR 870.2880. Ausonics Pty , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1989
Date Received
May 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic
Device Class
Class II
Regulation Number
870.2880
Review Panel
CV
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)
  • 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)
  • 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)

Other clearances for product code JOP

  • K242662 — Falcon/Xpress (Falcon/Xpress) (December 18, 2024)
  • K233976 — VasoGuard (V10, V8, V6, V4, V2) (July 19, 2024)
  • K153762 — Smartdop XT6 (May 25, 2016)
  • K131623 — SMARTDOP XT (January 17, 2014)
  • K131860 — VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING (September 27, 2013)
  • K111416 — FALCON (July 15, 2011)
  • K071730 — STUDIODOP VICORDER (December 20, 2007)
  • K010482 — ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1 (March 20, 2001)
  • K002766 — NICOLET VASOGUARD (November 30, 2000)
  • K990642 — ECHOFLOW DOPPLER BLOOD VELOCITY METER (September 16, 1999)

FDA data resources