Ausonics Pty , Ltd.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Ausonics Pty , Ltd.” (first 1979, latest 1994), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ausonics Pty , Ltd.?
FDA lists 27 510(k) clearances under the applicant name “Ausonics Pty , Ltd.” (first 1979, latest 1994), across 11 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ausonics Pty , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ausonics Pty , Ltd. is 90 days.
Which FDA product codes appear under Ausonics Pty , Ltd.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 12); ITX (Transducer, Ultrasonic, Diagnostic, 3); IZH (System, X-Ray, Mammographic, 3).
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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.