Echocardiograph
FDA product code DXK · Class II (moderate risk) · 21 CFR 870.2330 · Cardiovascular
78510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Biosound, Inc. 5
- Hewlett-Packard Co. 4
- Hitachi Medical Corp. of America 4
- Prism Imaging, Inc. 4
- Honeywell, Inc. 3
- Toshiba Medical Systems 3
- Advanced Technology Laboratories, Inc. 3
- Interspec, Inc. 2
- Del Mar Avionics 2
- Boston Scientific Corporation 2
- Highstoy 2
- Philips Medical Systems (Cleveland) Inc 2
- Ge Medical Systems Information Technologies 2
- Ausonics Pty , Ltd. 1
- American Edwards Laboratories 1
- Pfizer Medical Systems, Inc. 1
- Cambridge Instruments, Inc. 1
- Smithkline Diagnostics, Inc. 1
- Alltek Hospital Supplies , Ltd. 1
- Ipco Corp. 1
510(k) clearances
| 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 |
| K904975 | Vista Viewing StationDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
| K910029 | Patient Care Management System ModificationDXK · Traditional | Spacelabs, Inc. | 01/31/1991SE |
| K903839 | Interspec ApogeeDXK · Traditional | Interspec, Inc. | 11/16/1990SE |
| K903710 | Washington Cardiac MonitorDXK · Traditional | Washington Biolab, Inc. | 11/09/1990SE |
| K901592 | Model MD-5 DopplerDXK · Traditional | D. E. Hokanson, Inc. | 10/22/1990SE |
| K903414 | Transesophageal Probe Holder & Disinfecting ColumnDXK · Traditional | Echo Ultrasound | 09/19/1990SE |
| K901658 | Add'L Transducer for Use W/EUB-165 UltrasoundDXK · Traditional | Hitachi Medical Corp. of America | 09/04/1990SE |
| K901657 | Add'L Transducer for Use W/EUB-565 UltrasoundDXK · Traditional | Hitachi Medical Corp. of America | 09/04/1990SE |
| K900350 | Leocor Corflo(Tm) PumpDXK · Traditional | Leocor, Inc. | 07/17/1990SE |
| K901562 | Cvis Insight Imaging CatheterDXK · Traditional | Cardiovascular Imaging Systems, Inc. | 07/09/1990SE |
| K900002 | Doppler Option for PlatinumDXK · Traditional | Philips Medical Systems North America, Inc. | 04/02/1990SE |
| K895326 | EUB-165DXK · Traditional | Hitachi Medical Corp. of America | 03/22/1990SE |
| K896543 | Ultramark 7 Ultrasound SystemDXK · Traditional | Advanced Technology Laboratories, Inc. | 02/15/1990SE |
| K894370 | Genesis III, (Mod. 7003/7004)DXK · Traditional | Biosound, Inc. | 01/29/1990SE |
| K894632 | Model SSH-140A Ultrasound Imaging SystemDXK · Traditional | Toshiba America Medical Systems, In.C | 10/19/1989SE |
| K885349 | Sonomicrometer, Ultrasonic Dimension System, Card.DXK · Traditional | Sonotek Corp. | 06/22/1989SE |
| K883845 | Resubmitted Ai 5200 Ultrasound TransducerDXK · Traditional | Phoenix Imaging | 02/03/1989SE |
| K883888 | Cathscanner Intravascular Ultrasonic Imaging Syst.DXK · Traditional | Advanced Biosearch Assn. | 12/12/1988SE |
| K880217 | SSD-870 Cardio Vascular Phased Array Sector Scann.DXK · Traditional | Ge Medical Systems Information Technologies | 04/25/1988SE |
| K870878 | EUB-305 Diagnostic Ultrasound DeviceDXK · Traditional | Hitachi Medical Corp. of America | 04/22/1988SE |
| K871555 | RT5000 W/Quanti. Spec. Doppler, CW Dopp. Modifica.DXK · Traditional | General Electric Co. | 03/02/1988SE |
| K875272 | Sonoline CFDXK · Traditional | Siemens Medical Laboratories, Inc. | 02/18/1988SE |
| K873762 | Series 77000 Ultrasound Imaging SystemDXK · Traditional | Hewlett-Packard Co. | 02/18/1988SE |
| K873032 | Genesis II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM anDXK · Traditional | Biosound, Inc. | 02/18/1988SE |
| K871697 | Genesis IIDXK · Traditional | Biosound, Inc. | 11/06/1987SE |
| K863387 | MultipleDXK · Traditional | Del Mar Avionics | 09/04/1987SE |
| K871400 | SSD-650 Linear, Convex Sector, Ultrasound ScanningDXK · Traditional | Ge Medical Systems Information Technologies | 07/24/1987SE |
| K863589 | Model 600 Vascular Duplex ImagerDXK · Traditional | Multigon Industries, Inc. | 06/24/1987SE |
| K864657 | Atl's Ultramark 6 Ultrasound SystemDXK · Traditional | Advanced Technology Laboratories, Inc. | 02/02/1987SE |
| K862859 | Eub 151 Ultrasound System/Eub 150 UltrasoundDXK · Traditional | Biosound, Inc. | 02/02/1987SE |
| K863965 | Kenz-Ecg 102DXK · Traditional | Compumed, Inc. | 12/22/1986SE |
| K861710 | Model Ust-Ssd 880L1-5 Tranesophageal Phased ArrayDXK · Traditional | Johnson & Johnson Professionals, Inc. | 07/09/1986SE |
| K855229 | CFM-10 Vingmed Color Flow Mapping SystemDXK · Traditional | Vingmed, Inc. | 03/25/1986SE |
| K853115 | Sonolayer S, SSH-60A/SDS-60ADXK · Traditional | Toshiba Medical Systems | 03/12/1986SE |
| K852739 | Sonoline SX Ultrasound ScannerDXK · Traditional | Siemens Medical Solutions USA, Inc. | 03/10/1986SE |
| K854606 | Sonolayer S, SSH-65ADXK · Traditional | Toshiba Medical Systems | 02/20/1986SE |
| K853769 | Irregular Curve Tracing Revisition & DopplerDXK · Traditional | Hewlett-Packard Co. | 10/31/1985SE |
| K851901 | 750 SD Ultrasound Scanner(Modification)DXK · Traditional | Ultrasonix, Inc. | 10/23/1985SE |
| K852543 | Kontron Sigma Isc Echocardiograph SystemDXK · Traditional | Kontron Instruments, Inc. | 09/20/1985SE |
| K851426 | Accucom Cardiac Output MonitorDXK · Traditional | Lawrence Medical Systems, Inc. | 07/12/1985SE |
| K844896 | Del Mar Avionics 8300 Sector Imager SysDXK · Traditional | Del Mar Avionics | 06/10/1985SE |
| K843643 | Color Doppler 880DXK · Traditional | Irex Corp. | 01/31/1985SE |
| K841263 | Cardioscan - TM Being Applied forDXK · Traditional | Interspec, Inc. | 10/19/1984SE |
| K822425 | M-Mode Analysis SystemDXK · Traditional | User Resources, Inc. | 10/04/1982SE |
| K822236 | Franklin Quantic 1200DXK · Traditional | Bruce Franklin, Inc. | 08/31/1982SE |
| K820145 | Alltek Brompton EncoderDXK · Traditional | Alltek Hospital Supplies , Ltd. | 03/02/1982SE |
| K813002 | Mavis CDXK · Traditional | Philips Medical Systems (Cleveland), Inc. | 03/01/1982SE |
| K812646 | Ski 5000DXK · Traditional | Smithkline Diagnostics, Inc. | 11/16/1981SE |
| K812209 | Ultra ComDXK · Traditional | Ultranamics, Inc. | 11/16/1981SE |
| K812184 | Angioscan Spectrum AnalyzerDXK · Traditional | Unigon Industries, Inc. | 09/09/1981SE |
| K811595 | SP-100-B Small Parts Scanner SystemDXK · Traditional | Highstoy | 08/12/1981SE |
| K811556 | DC-1 Cardiac Imaging ModuleDXK · Traditional | Diasonics, Inc. | 07/10/1981SE |
| K802917 | Mark III Ultrasonic Scanning SystemDXK · Traditional | Advanced Technology Laboratories, Inc. | 01/16/1981SE |
| K802529 | Pfizonic 100 Ultrasound ScannerDXK · Traditional | Pfizer Medical Systems, Inc. | 12/18/1980SE |
| K802670 | Contiuous Wave Doppler UltrasoundDXK · Traditional | American Edwards Laboratories | 11/26/1980SE |
| K802030 | U.I. OctosonDXK · Traditional | Ausonics Pty , Ltd. | 10/03/1980SE |
| K800850 | High Stoy Small Parts Scanner #SP-100BDXK · Traditional | Highstoy | 07/21/1980SE |
| K800805 | Linear Array ScannerDXK · Traditional | Philips Medical Systems (Cleveland), Inc. | 07/21/1980SE |
| K800653 | Sinvision Linear Array Real TimeDXK · Traditional | Kt Medical, Inc. | 07/21/1980SE |
| K800553 | Ultra ImagerDXK · Traditional | Honeywell, Inc. | 07/21/1980SE |
| K801224 | Cambridge Cardiac Diagnostic SystemDXK · Traditional | Cambridge Instruments, Inc. | 06/26/1980SE |
| K792373 | Ipco M-101 Echocardiograph (Ipco Ultra-DXK · Traditional | Ipco Corp. | 02/13/1980SE |
| K792540 | Sonacolor 6000DXK · Traditional | Carolina Medical Electronics | 01/17/1980SE |
| K780332 | Cathode Ray Tube Display Model 1340ADXK · Traditional | Hewlett-Packard Co. | 03/22/1978SE |
| K771292 | High-Speed Sector Scanning SSL-52HDXK · Traditional | Toshiba Medical Systems | 08/16/1977SE |
| K770756 | Echocardiography Sys., Model 3860DXK · Traditional | Honeywell, Inc. | 05/09/1977SE |
| K770755 | Echocardiography Sys., Model 3830DXK · Traditional | Honeywell, Inc. | 05/09/1977SE |
| K770073 | Primus Inter Paresechocardiography Sys.DXK · Traditional | Rohe Scientific Corp. | 01/25/1977SE |