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

1-12 of 23

Cleared Oct 03, 1994

AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER

Radiology · 418d

Cleared Jul 02, 1992

CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER

Radiology · 268d

Cleared May 19, 1992

AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION

Radiology · 117d

Cleared Dec 18, 1991

DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN

Radiology · 376d

Cleared Feb 13, 1991

7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)

Radiology · 237d

Cleared Jun 11, 1990

Radiology · 194d

Cleared Jan 10, 1989

APA-C CATALOG NUMBER A-8001-C

Radiology · 89d

Cleared Dec 15, 1988

Radiology · 90d

Cleared Dec 14, 1988

WWDS-005 HUMAN RECTAL PROBE

Radiology · 146d

Cleared Nov 25, 1988

ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT

Radiology · 107d

Cleared Jan 30, 1987

ALPHA II DIAGNOSTIC X-RAY

Radiology · 43d

Cleared Oct 14, 1986

ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT

Radiology · 21d