U.I. Octoson
FDA 510(k) K802030 · Ausonics Pty , Ltd.
510(k) numberK802030
Submission
- Device name
- U.I. Octoson
- Applicant
- Ausonics Pty , Ltd.
Mchenry, IL, US - Received
- August 21, 1980
- Decision date
- October 3, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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| K181042 | Ultra ICE Plus PI 9 MHz Peripheral Imaging CatheterDXK · Special | Boston Scientific Corporation | 05/17/2018SE |
| K160173 | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac…DXK · Special | Boston Scientific Corporation | 02/26/2016SE |
| K031148 | In-Vision Imaging SystemDXK · Special | Jomed, Inc. | 05/28/2003SE |
| K934887 | 9750 Athena Ethernet OptionDXK · Traditional | S & W Medico Teknik A/S | 01/14/1994SE |
| K913209 | Accessory to Genesis III (GCFM)DXK · Traditional | Biosound, Inc. | 05/15/1992SE |
| K911384 | Cathscanner(R) Visions(Tm) 3.5F 54700/5.0F 54600DXK · Traditional | Endosonics Corp. | 06/25/1991SE |
| K904832 | Modified Syst: Sonos 500/1000 Ultrsound Imag SystDXK · Traditional | Hewlett-Packard Co. | 04/22/1991SE |
| K904978 | Software Program Used W/Prism ProductsDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904977 | Cine/View Plus - Cardiology WorkstationDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K904976 | Cine'View - Stress Echo & Image ReviewDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
More from Prism Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933916 | Ausonics Opus 2 Realtime Ultrasound ScannerIYN · Traditional | 10/03/1994SE |
| K915715 | Cine Recall Function/Opus 1 Real Time ScannerIYO · Traditional | 07/02/1992SE |
| 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 |
| K896714 | Ausonics 5000IYO · Traditional | 06/11/1990SE |
| 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 |
Questions and answers
When was U.I. Octoson cleared by the FDA?
U.I. Octoson (K802030) received a 510(k) decision of Substantially Equivalent on October 3, 1980, 43 days after the submission was received.
What is the product code of K802030?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.