Ausonics 5000
FDA 510(k) K896714 · Ausonics Pty , Ltd.
510(k) numberK896714
Submission
- Device name
- Ausonics 5000
- Applicant
- Ausonics Pty , Ltd.
Suffield, CT, US - Received
- November 29, 1989
- Decision date
- June 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K933916 | Ausonics Opus 2 Realtime Ultrasound ScannerIYN · Traditional | 10/03/1994SE |
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| K920307 | Ausonics Opus 1 System, Annular Array OptionITX · Traditional | 05/19/1992SE |
| K905488 | Doppler Upgrade for Ausonics Opus 1 Real Time ScanLMB · Traditional | 12/18/1991SE |
| K902728 | 7.5 MHZ Bi Plane Rectal Probe (P/N: 041-815)ITX · Traditional | 02/13/1991SE |
| K881979 | Resubmittal of Mi 1000C MicroimagerJOP · Traditional | 06/12/1989SE |
| K884299 | Apa-C Catalog Number A-8001-CIYO · Traditional | 01/10/1989SE |
| K883925 | UroimagerIYO · Traditional | 12/15/1988SE |
| K883079 | WWDS-005 Human Rectal ProbeIYO · Traditional | 12/14/1988SE |
| K883372 | Alpha MC-9S Mobil C-Arm Image Intensifier UnitJAA · Traditional | 11/25/1988SE |
Questions and answers
When was Ausonics 5000 cleared by the FDA?
Ausonics 5000 (K896714) received a 510(k) decision of Substantially Equivalent on June 11, 1990, 194 days after the submission was received.
What is the product code of K896714?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.