DXK · Echocardiograph
Cardiovascular · 21 CFR 870.2330 · Class 2
Overview
| Product Code | DXK |
|---|---|
| Device Name | Echocardiograph |
| Regulation | 21 CFR 870.2330 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 78)
Showing 20 most recent of 78 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K181042 | Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | May 17, 2018 | SESE |
| K160173 | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) | Boston Scientific Corporation | Feb 26, 2016 | SESE |
| K031148 | IN-VISION IMAGING SYSTEM | Jomed, Inc. | May 28, 2003 | SESE |
| K934887 | 9750 ATHENA ETHERNET OPTION | S & W Medico Teknik A/S | Jan 14, 1994 | SESE |
| K913209 | ACCESSORY TO GENESIS III (GCFM) | Biosound, Inc. | May 15, 1992 | SESE |
| K911384 | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 | Endosonics Corp. | Jun 25, 1991 | SESE |
| K904832 | MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST | Hewlett-Packard Co. | Apr 22, 1991 | SESE |
| K904978 | SOFTWARE PROGRAM USED W/PRISM PRODUCTS | Prism Imaging, Inc. | Feb 25, 1991 | SESE |
| K904977 | CINE/VIEW PLUS - CARDIOLOGY WORKSTATION | Prism Imaging, Inc. | Feb 25, 1991 | SESE |
| K904976 | CINE'VIEW - STRESS ECHO & IMAGE REVIEW | Prism Imaging, Inc. | Feb 25, 1991 | SESE |
| K904975 | VISTA VIEWING STATION | Prism Imaging, Inc. | Feb 25, 1991 | SESE |
| K910029 | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION | Spacelabs, Inc. | Jan 31, 1991 | SESE |
| K903839 | INTERSPEC APOGEE | Interspec, Inc. | Nov 16, 1990 | SESE |
| K903710 | WASHINGTON CARDIAC MONITOR | Washington Biolab, Inc. | Nov 9, 1990 | SESE |
| K901592 | MODEL MD-5 DOPPLER | D. E. Hokanson, Inc. | Oct 22, 1990 | SESE |
| K903414 | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN | Echo Ultrasound | Sep 19, 1990 | SESE |
| K901658 | ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND | Hitachi Medical Corp. of America | Sep 4, 1990 | SESE |
| K901657 | ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND | Hitachi Medical Corp. of America | Sep 4, 1990 | SESE |
| K900350 | LEOCOR CORFLO(TM) PUMP | Leocor, Inc. | Jul 17, 1990 | SESE |
| K901562 | CVIS INSIGHT IMAGING CATHETER | Cardiovascular Imaging Systems, Inc. | Jul 9, 1990 | SESE |
Top Applicants
- Biosound, Inc. — 5 clearances
- Hewlett-Packard Co. — 4 clearances
- Hitachi Medical Corp. of America — 4 clearances
- Prism Imaging, Inc. — 4 clearances
- Advanced Technology Laboratories, Inc. — 3 clearances
