Medical Device Manufacturer · US , Mchenry , IL

Ausonics Pty , Ltd. - FDA 510(k) Cleared Devices

27 submissions · 26 cleared · Since 1979
27
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ausonics Pty , Ltd. Radiology
23 devices
1-23 of 23
Cleared Oct 03, 1994
AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER
K933916 · IYN
Radiology · 418d
Cleared Jul 02, 1992
CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER
K915715 · IYO
Radiology · 268d
Cleared May 19, 1992
AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION
K920307 · ITX
Radiology · 117d
Cleared Dec 18, 1991
DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN
K905488 · LMB
Radiology · 376d
Cleared Feb 13, 1991
7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)
K902728 · ITX
Radiology · 237d
Cleared Jun 11, 1990
AUSONICS 5000
K896714 · IYO
Radiology · 194d
Cleared Jan 10, 1989
APA-C CATALOG NUMBER A-8001-C
K884299 · IYO
Radiology · 89d
Cleared Dec 15, 1988
UROIMAGER
K883925 · IYO
Radiology · 90d
Cleared Dec 14, 1988
WWDS-005 HUMAN RECTAL PROBE
K883079 · IYO
Radiology · 146d
Cleared Nov 25, 1988
ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K883372 · JAA
Radiology · 107d
Cleared Jan 30, 1987
ALPHA II DIAGNOSTIC X-RAY
K864958 · IZH
Radiology · 43d
Cleared Oct 14, 1986
ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K863710 · IZH
Radiology · 21d
Cleared Aug 18, 1986
SONORANGER
K862166 · IYO
Radiology · 70d
Cleared Mar 26, 1986
7.5 MHZ SHORT FOCUS FLUID OFFSET PROBE #041-726T
K860494 · ITX
Radiology · 44d
Cleared Aug 14, 1985
SONORANGER
K852549 · IYO
Radiology · 58d
Cleared May 22, 1985
AUSONICS 150
K851696 · IYO
Radiology · 28d
Cleared Apr 18, 1985
AUSONICS 150
K843971 · IYO
Radiology · 189d
Cleared Apr 18, 1985
AUSONICS 357
K843994 · IYO
Radiology · 189d
Cleared Apr 16, 1985
AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
K850173 · IZH
Radiology · 90d
Cleared Mar 17, 1983
ULTRASONIC ECHOSCOPE
K837171
Radiology · 29d
Cleared Jul 10, 1981
CIRAS ULTRASONIC SCANNING SYSTEM
K811633 · IYO
Radiology · 31d
Cleared Oct 23, 1980
U.I. OCTOSON
K801675 · LEJ
Radiology · 93d
Cleared Dec 20, 1979
OCTOSON
K792388 · IYO
Radiology · 24d
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