Doppler Option for Platinum
FDA 510(k) K900002 · Philips Medical Systems North America, Inc.
510(k) numberK900002
Submission
- Device name
- Doppler Option for Platinum
- Applicant
- Philips Medical Systems North America, Inc.
Santa Ana, CA, US - Received
- January 2, 1990
- Decision date
- April 2, 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 |
|---|---|---|
| K101311 | Ep Navigator R3LLZ · Traditional | 09/30/2010SE |
| K102005 | Allura Xper or Table SeriesOWB · Traditional | 08/09/2010SE |
| K090625 | Wireless Portable Detector FD-W17MQB · Traditional | 03/24/2009SE |
| K090590 | Veradius, Model 718-130OWB · Traditional | 03/16/2009SE |
| K082280 | Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital…MHX · Special | 10/08/2008SE |
| K063781 | Philips Xd-S Direct Radiography Workstation/PackageLLZ · Traditional | 01/05/2007SE |
| K062233 | Heartstart MRX Monitor/DefibrillatorMKJ · Special | 11/22/2006SE |
| K062268 | Masimo Set SPO2 Module for Philips and M3001A Multi-Measurement Server Option A03DQA · Special | 10/18/2006SE |
| K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsMHX · Special | 09/20/2006SE |
| K061685 | PulseraIZL · Traditional | 09/15/2006SE |
Questions and answers
When was Doppler Option for Platinum cleared by the FDA?
Doppler Option for Platinum (K900002) received a 510(k) decision of Substantially Equivalent on April 2, 1990, 90 days after the submission was received.
What is the product code of K900002?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.