Ausonics Pty , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K933916AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNEROctober 3, 1994
K915715CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNERJuly 2, 1992
K920307AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTIONMay 19, 1992
K905488DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCANDecember 18, 1991
K9027287.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)February 13, 1991
K896714AUSONICS 5000June 11, 1990
K881979RESUBMITTAL OF MI 1000C MICROIMAGERJune 12, 1989
K884299APA-C CATALOG NUMBER A-8001-CJanuary 10, 1989
K883925UROIMAGERDecember 15, 1988
K883079WWDS-005 HUMAN RECTAL PROBEDecember 14, 1988
K883372ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNITNovember 25, 1988
K864958ALPHA II DIAGNOSTIC X-RAYJanuary 30, 1987
K863710ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNITOctober 14, 1986
K862166SONORANGERAugust 18, 1986
K862627SONORANGER TRANSVAGINAL PROBEAugust 1, 1986
K8604947.5 MHZ SHORT FOCUS FLUID OFFSET PROBE #041-726TMarch 26, 1986
K852549SONORANGERAugust 14, 1985
K8516163.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CAJuly 29, 1985
K851696AUSONICS 150May 22, 1985
K843971AUSONICS 150April 18, 1985