DXK — Echocardiograph Class II
FDA product code DXK covers "Echocardiograph", a Class II medical device regulated under 21 CFR 870.2330. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DXK
- Device Class
- Class II
- Regulation Number
- 870.2330
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K181042 | boston scientific corporation | Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter | May 17, 2018 |
| K160173 | boston scientific corporation | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz Intr | February 26, 2016 |
| K031148 | jomed | IN-VISION IMAGING SYSTEM | May 28, 2003 |
| K934887 | s and w medico teknik | 9750 ATHENA ETHERNET OPTION | January 14, 1994 |
| K913209 | biosound | ACCESSORY TO GENESIS III (GCFM) | May 15, 1992 |
| K911384 | endosonics | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 | June 25, 1991 |
| K904832 | hewlett-packard | MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST | April 22, 1991 |
| K904976 | prism imaging | CINE'VIEW - STRESS ECHO & IMAGE REVIEW | February 25, 1991 |
| K904977 | prism imaging | CINE/VIEW PLUS - CARDIOLOGY WORKSTATION | February 25, 1991 |
| K904975 | prism imaging | VISTA VIEWING STATION | February 25, 1991 |
| K904978 | prism imaging | SOFTWARE PROGRAM USED W/PRISM PRODUCTS | February 25, 1991 |
| K910029 | spacelabs | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION | January 31, 1991 |
| K903839 | interspec | INTERSPEC APOGEE | November 16, 1990 |
| K903710 | washington biolab | WASHINGTON CARDIAC MONITOR | November 9, 1990 |
| K901592 | d. e. hokanson | MODEL MD-5 DOPPLER | October 22, 1990 |
| K903414 | echo ultrasound | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN | September 19, 1990 |
| K901658 | hitachi medical corp. of america | ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND | September 4, 1990 |
| K901657 | hitachi medical corp. of america | ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND | September 4, 1990 |
| K900350 | leocor | LEOCOR CORFLO(TM) PUMP | July 17, 1990 |
| K901562 | cardiovascular imaging systems | CVIS INSIGHT IMAGING CATHETER | July 9, 1990 |