Ausonics Pty, Ltd.
Mchenry, IL, US
Ausonics Pty , Ltd. appears in FDA device records in Mchenry, IL. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Ausonics Pty, Ltd. between 1979 and 1994. The busiest year on record is 1985, with 6. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 2 |
| 1981 | 1 |
| 1983 | 1 |
| 1985 | 6 |
| 1986 | 4 |
| 1987 | 1 |
| 1988 | 3 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 2 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K933916 | AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER | IYN | Substantially Equivalent | |
| K915715 | CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER | IYO | Substantially Equivalent | |
| K920307 | AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION | ITX | Substantially Equivalent | |
| K905488 | DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN | LMB | Substantially Equivalent | |
| K902728 | 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) | ITX | Substantially Equivalent | |
| K896714 | AUSONICS 5000 | IYO | Substantially Equivalent | |
| K881979 | RESUBMITTAL OF MI 1000C MICROIMAGER | JOP | Substantially Equivalent | |
| K884299 | APA-C CATALOG NUMBER A-8001-C | IYO | Substantially Equivalent | |
| K883925 | UROIMAGER | IYO | Substantially Equivalent | |
| K883079 | WWDS-005 HUMAN RECTAL PROBE | IYO | Substantially Equivalent | |
| K883372 | ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT | JAA | Substantially Equivalent | |
| K864958 | ALPHA II DIAGNOSTIC X-RAY | IZH | Substantially Equivalent | |
| K863710 | ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT | IZH | Substantially Equivalent | |
| K862166 | SONORANGER | IYO | Substantially Equivalent | |
| K862627 | SONORANGER TRANSVAGINAL PROBE | HEM | Substantially Equivalent for Some Indications | |
| K860494 | 7.5 MHZ SHORT FOCUS FLUID OFFSET PROBE #041-726T | ITX | Substantially Equivalent | |
| K852549 | SONORANGER | IYO | Substantially Equivalent | |
| K851616 | 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA | JOP | Substantially Equivalent | |
| K851696 | AUSONICS 150 | IYO | Substantially Equivalent | |
| K843994 | AUSONICS 357 | IYO | Substantially Equivalent | |
| K843971 | AUSONICS 150 | IYO | Substantially Equivalent | |
| K850173 | AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT | IZH | Substantially Equivalent | |
| K837171 | ULTRASONIC ECHOSCOPE | Substantially Equivalent | ||
| K811633 | CIRAS ULTRASONIC SCANNING SYSTEM | IYO | Substantially Equivalent | |
| K801675 | U.I. OCTOSON | LEJ | Substantially Equivalent | |
| K802030 | U.I. OCTOSON | DXK | Substantially Equivalent | |
| K792388 | OCTOSON | IYO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LEJBooth, Sun Tan
- LMBDevice, Digital Image Storage, Radiological
- DXKEchocardiograph
- HEMImager, Ultrasonic Obstetric-Gynecologic
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZHSystem, X-Ray, Mammographic
- JOPTransducer, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain