Add'L Transducer for Use W/EUB-565 Ultrasound
FDA 510(k) K901657 · Hitachi Medical Corp. of America
510(k) numberK901657
Submission
- Device name
- Add'L Transducer for Use W/EUB-565 Ultrasound
- Applicant
- Hitachi Medical Corp. of America
Tarrytown, NY, US - Received
- April 10, 1990
- Decision date
- September 4, 1990
- 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
Other 510(k)s with product code DXK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K994026 | EUB-6000 Ultrasound Diagnostic ScannerIYN · Traditional | 03/29/2000SE |
| K991535 | Convergence CDR for Hitachi Spectradigital V250DSP Gamma CamerasKPS · Traditional | 07/30/1999SE |
| K991318 | Convergence Nua for Hitachi Spectradigital V250DSP Gamma CamerasKPS · Traditional | 06/18/1999SE |
| K991129 | Hitachi Spectradigital V250DSP Gamma Camera System with Thick Nal(Ti) CrystalKPS · Traditional | 05/13/1999SE |
| K981434 | EUP-OL334 LaparascopicprobeITX · Traditional | 07/27/1998SE |
| K954220 | EUB-8000IYN · Traditional | 05/07/1997SE |
| K962308 | EUB-905IYO · Traditional | 07/17/1996SE |
| K954143 | Hitachi Spectradigital Series Gamma Camera SystemsKPS · Traditional | 12/22/1995SE |
| K954129 | Spectradigital Series V250DSPKPS · Traditional | 12/22/1995SE |
| K945400 | Hitachi Dynamic 3D Imaging SYSTEM,SF-VA100IZI · Traditional | 11/20/1995SE |
Questions and answers
When was Add'L Transducer for Use W/EUB-565 Ultrasound cleared by the FDA?
Add'L Transducer for Use W/EUB-565 Ultrasound (K901657) received a 510(k) decision of Substantially Equivalent on September 4, 1990, 147 days after the submission was received.
What is the product code of K901657?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.