Company ยท US
Ausonics Pty , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1994. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 12 |
| ITX | Transducer, Ultrasonic, Diagnostic | 3 |
| IZH | System, X-Ray, Mammographic | 3 |
| JOP | Transducer, Ultrasonic | 2 |
| DXK | Echocardiograph | 1 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
| LEJ | Booth, Sun Tan | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 3, 1994 | K933916 | AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER Ausonics Pty , Ltd. | IYN |
| Jul 2, 1992 | K915715 | CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER Ausonics Pty , Ltd. | IYO |
| May 19, 1992 | K920307 | AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION Ausonics Pty , Ltd. | ITX |
| Dec 18, 1991 | K905488 | DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN Ausonics Pty , Ltd. | LMB |
| Feb 13, 1991 | K902728 | 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) Ausonics Pty , Ltd. | ITX |
| Jun 11, 1990 | K896714 | AUSONICS 5000 Ausonics Pty , Ltd. | IYO |
| Jun 12, 1989 | K881979 | RESUBMITTAL OF MI 1000C MICROIMAGER Ausonics Pty , Ltd. | JOP |
| Jan 10, 1989 | K884299 | APA-C CATALOG NUMBER A-8001-C Ausonics Pty , Ltd. | IYO |
| Dec 15, 1988 | K883925 | UROIMAGER Ausonics Pty , Ltd. | IYO |
| Dec 14, 1988 | K883079 | WWDS-005 HUMAN RECTAL PROBE Ausonics Pty , Ltd. | IYO |
| Nov 25, 1988 | K883372 | ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT Ausonics Pty , Ltd. | JAA |
| Jan 30, 1987 | K864958 | ALPHA II DIAGNOSTIC X-RAY Ausonics Pty , Ltd. | IZH |
| Oct 14, 1986 | K863710 | ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT Ausonics Pty , Ltd. | IZH |
| Aug 18, 1986 | K862166 | SONORANGER Ausonics Pty , Ltd. | IYO |
| Aug 1, 1986 | K862627 | SONORANGER TRANSVAGINAL PROBE Ausonics Pty , Ltd. | HEM |
| Mar 26, 1986 | K860494 | 7.5 MHZ SHORT FOCUS FLUID OFFSET PROBE #041-726T Ausonics Pty , Ltd. | ITX |
| Aug 14, 1985 | K852549 | SONORANGER Ausonics Pty , Ltd. | IYO |
| Jul 29, 1985 | K851616 | 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA Ausonics Pty , Ltd. | JOP |
| May 22, 1985 | K851696 | AUSONICS 150 Ausonics Pty , Ltd. | IYO |
| Apr 18, 1985 | K843994 | AUSONICS 357 Ausonics Pty , Ltd. | IYO |
| Apr 18, 1985 | K843971 | AUSONICS 150 Ausonics Pty , Ltd. | IYO |
| Apr 16, 1985 | K850173 | AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT Ausonics Pty , Ltd. | IZH |
| Mar 17, 1983 | K837171 | ULTRASONIC ECHOSCOPE Ausonics Pty , Ltd. | |
| Jul 10, 1981 | K811633 | CIRAS ULTRASONIC SCANNING SYSTEM Ausonics Pty , Ltd. | IYO |
| Oct 23, 1980 | K801675 | U.I. OCTOSON Ausonics Pty , Ltd. | LEJ |
| Oct 3, 1980 | K802030 | U.I. OCTOSON Ausonics Pty , Ltd. | DXK |
| Dec 20, 1979 | K792388 | OCTOSON Ausonics Pty , Ltd. | IYO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||