Product code DXK
- Device name
- Echocardiograph
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2330
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181042 | Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2018-05-17 |
| K160173 | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) | Boston Scientific Corporation | 2016-02-26 |
| K031148 | IN-VISION IMAGING SYSTEM | Jomed, Inc. | 2003-05-28 |
| K934887 | 9750 ATHENA ETHERNET OPTION | S & W Medico Teknik A/S | 1994-01-14 |
| K913209 | ACCESSORY TO GENESIS III (GCFM) | Biosound, Inc. | 1992-05-15 |
| K911384 | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 | Endosonics Corp. | 1991-06-25 |
| K904832 | MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST | Hewlett-Packard Co. | 1991-04-22 |
| K904978 | SOFTWARE PROGRAM USED W/PRISM PRODUCTS | Prism Imaging, Inc. | 1991-02-25 |
| K904977 | CINE/VIEW PLUS - CARDIOLOGY WORKSTATION | Prism Imaging, Inc. | 1991-02-25 |
| K904976 | CINE'VIEW - STRESS ECHO & IMAGE REVIEW | Prism Imaging, Inc. | 1991-02-25 |
| K904975 | VISTA VIEWING STATION | Prism Imaging, Inc. | 1991-02-25 |
| K910029 | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION | Spacelabs, Inc. | 1991-01-31 |
| K903839 | INTERSPEC APOGEE | Interspec, Inc. | 1990-11-16 |
| K903710 | WASHINGTON CARDIAC MONITOR | Washington Biolab, Inc. | 1990-11-09 |
| K901592 | MODEL MD-5 DOPPLER | D. E. Hokanson, Inc. | 1990-10-22 |
| K903414 | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN | Echo Ultrasound | 1990-09-19 |
| K901658 | ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND | Hitachi Medical Corp. of America | 1990-09-04 |
| K901657 | ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND | Hitachi Medical Corp. of America | 1990-09-04 |
| K900350 | LEOCOR CORFLO(TM) PUMP | Leocor, Inc. | 1990-07-17 |
| K901562 | CVIS INSIGHT IMAGING CATHETER | Cardiovascular Imaging Systems, Inc. | 1990-07-09 |
| K900002 | DOPPLER OPTION FOR PLATINUM | Philips Medical Systems North America, Inc. | 1990-04-02 |
| K895326 | EUB-165 | Hitachi Medical Corp. of America | 1990-03-22 |
| K896543 | ULTRAMARK 7 ULTRASOUND SYSTEM | Advanced Technology Laboratories, Inc. | 1990-02-15 |
| K894370 | GENESIS III, (MOD. 7003/7004) | Biosound, Inc. | 1990-01-29 |
| K894632 | MODEL SSH-140A ULTRASOUND IMAGING SYSTEM | Toshiba America Medical Systems, In.C | 1989-10-19 |
| K885349 | SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. | Sonotek Corp. | 1989-06-22 |
| K883845 | RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER | Phoenix Imaging | 1989-02-03 |
| K883888 | CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. | Advanced Biosearch Assn. | 1988-12-12 |
| K880217 | SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN. | Ge Medical Systems Information Technologies | 1988-04-25 |
| K870878 | EUB-305 DIAGNOSTIC ULTRASOUND DEVICE | Hitachi Medical Corp. of America | 1988-04-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729982500 | Ultra ICE™ Plus - PI | BOSTON SCIENTIFIC CORPORATION | 2021-02-02 |
| 00817065021303 | Hokanson | D.E.HOKANSON, INC. | 2016-09-16 |
| 00817065021327 | Hokanson | D.E.HOKANSON, INC. | 2016-09-16 |
| 00817065021334 | Hokanson | D.E.HOKANSON, INC. | 2016-09-16 |
| 00817065021358 | Hokanson | D.E.HOKANSON, INC. | 2016-09-16 |
| 00817065021365 | Hokanson | D.E.HOKANSON, INC. | 2016-09-16 |
| 00817065021372 | Hokanson | D.E.HOKANSON, INC. | 2016-09-16 |
| 00817065021426 | Hokanson | D.E.HOKANSON, INC. | 2016-09-16 |
| 00817065021464 | Hokanson | D.E.HOKANSON, INC. | 2016-09-16 |
| 00817065021310 | Hokanson | D.E.HOKANSON, INC. | 2016-08-31 |