Ausonics Pty , Ltd.: FDA clearances and approvals
Ausonics Pty , Ltd. has 27 FDA 510(k) clearances (first 1979, latest 1994), across 11 product codes in 4 review panels. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 12 | 12 |
| ITX | Transducer, Ultrasonic, Diagnostic | 3 | 3 |
| IZH | System, X-Ray, Mammographic | 3 | 3 |
| JOP | Transducer, Ultrasonic | 2 | 2 |
| DXK | Echocardiograph | 1 | 1 |
| HEM | Imager, Ultrasonic Obstetric-Gynecologic | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| LEJ | Booth, Sun Tan | 1 | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Ausonics Pty , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933916 | AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER | IYN | 1994-10-03 | 418 |
| K915715 | CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER | IYO | 1992-07-02 | 268 |
| K920307 | AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION | ITX | 1992-05-19 | 117 |
| K905488 | DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN | LMB | 1991-12-18 | 376 |
| K902728 | 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) | ITX | 1991-02-13 | 237 |
| K896714 | AUSONICS 5000 | IYO | 1990-06-11 | 194 |
| K881979 | RESUBMITTAL OF MI 1000C MICROIMAGER | JOP | 1989-06-12 | 396 |
| K884299 | APA-C CATALOG NUMBER A-8001-C | IYO | 1989-01-10 | 89 |
| K883925 | UROIMAGER | IYO | 1988-12-15 | 90 |
| K883079 | WWDS-005 HUMAN RECTAL PROBE | IYO | 1988-12-14 | 146 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ausonics Pty , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ausonics Pty , Ltd. have?
Ausonics Pty , Ltd. has 27 FDA 510(k) clearances (first 1979, latest 1994), across 11 product codes in 4 review panels.
How long does FDA take to clear Ausonics Pty , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Ausonics Pty , Ltd.'s cleared 510(k)s is 90 days.
What devices does Ausonics Pty , Ltd. make?
Its most frequent FDA product codes are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 12); ITX (Transducer, Ultrasonic, Diagnostic, 3); IZH (System, X-Ray, Mammographic, 3).
Has Ausonics Pty , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ausonics Pty , Ltd. Related entities may recall under other names.
Next steps
- See all 27 Ausonics Pty , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Ausonics Pty , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.