Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ausonics Pty , Ltd. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
376 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K933916 | AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER | Ausonics Pty , Ltd. | 1994-10-03 | 418 | 0 |
| K915715 | CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER | Ausonics Pty , Ltd. | 1992-07-02 | 268 | 0 |
| K920307 | AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION | Ausonics Pty , Ltd. | 1992-05-19 | 117 | 0 |
| K905488 | DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN | Ausonics Pty , Ltd. | 1991-12-18 | 376 | 0 |
| K902728 | 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) | Ausonics Pty , Ltd. | 1991-02-13 | 237 | 0 |
| K896714 | AUSONICS 5000 | Ausonics Pty , Ltd. | 1990-06-11 | 194 | 0 |
| K881979 | RESUBMITTAL OF MI 1000C MICROIMAGER | Ausonics Pty , Ltd. | 1989-06-12 | 396 | 0 |
| K884299 | APA-C CATALOG NUMBER A-8001-C | Ausonics Pty , Ltd. | 1989-01-10 | 89 | 0 |
| K883925 | UROIMAGER | Ausonics Pty , Ltd. | 1988-12-15 | 90 | 0 |
| K883079 | WWDS-005 HUMAN RECTAL PROBE | Ausonics Pty , Ltd. | 1988-12-14 | 146 | 0 |
| K883372 | ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT | Ausonics Pty , Ltd. | 1988-11-25 | 107 | 0 |
| K864958 | ALPHA II DIAGNOSTIC X-RAY | Ausonics Pty , Ltd. | 1987-01-30 | 43 | 0 |
| K863710 | ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT | Ausonics Pty , Ltd. | 1986-10-14 | 21 | 0 |
| K862166 | SONORANGER | Ausonics Pty , Ltd. | 1986-08-18 | 70 | 0 |
| K862627 | SONORANGER TRANSVAGINAL PROBE | Ausonics Pty , Ltd. | 1986-08-01 | 22 | 0 |
| K860494 | 7.5 MHZ SHORT FOCUS FLUID OFFSET PROBE #041-726T | Ausonics Pty , Ltd. | 1986-03-26 | 44 | 0 |
| K852549 | SONORANGER | Ausonics Pty , Ltd. | 1985-08-14 | 58 | 0 |
| K851616 | 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA | Ausonics Pty , Ltd. | 1985-07-29 | 102 | 0 |
| K851696 | AUSONICS 150 | Ausonics Pty , Ltd. | 1985-05-22 | 28 | 0 |
| K843971 | AUSONICS 150 | Ausonics Pty , Ltd. | 1985-04-18 | 189 | 0 |
| K843994 | AUSONICS 357 | Ausonics Pty , Ltd. | 1985-04-18 | 189 | 0 |
| K850173 | AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT | Ausonics Pty , Ltd. | 1985-04-16 | 90 | 0 |
| K837171 | ULTRASONIC ECHOSCOPE | Ausonics Pty , Ltd. | 1983-03-17 | 29 | 0 |
| K811633 | CIRAS ULTRASONIC SCANNING SYSTEM | Ausonics Pty , Ltd. | 1981-07-10 | 31 | 0 |
| K801675 | U.I. OCTOSON | Ausonics Pty , Ltd. | 1980-10-23 | 93 | 0 |
| K802030 | U.I. OCTOSON | Ausonics Pty , Ltd. | 1980-10-03 | 43 | 0 |
| K792388 | OCTOSON | Ausonics Pty , Ltd. | 1979-12-20 | 24 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda