Panels › Cardiovascular › Product code DXK · Class 2
Echocardiograph
Regulation 870.2330
0510(k)s in 12 months (78 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DXK
| Company | 510(k)s | Recalls |
|---|---|---|
| Biosound, Inc. | 5 | 0 |
| Hewlett-Packard Co. | 4 | 0 |
| Hitachi Medical Corp. of America | 4 | 0 |
| Prism Imaging, Inc. | 4 | 0 |
| Advanced Technology Laboratories, Inc. | 3 | 0 |
| Honeywell, Inc. | 3 | 0 |
| Toshiba Medical Systems | 3 | 0 |
| Boston Scientific Corporation | 2 | 0 |
| Del Mar Avionics | 2 | 0 |
| Ge Medical Systems Information Technologies | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 17, 2018 | K181042 | Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter Boston Scientific Corporation | DXK |
| Feb 26, 2016 | K160173 | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) Boston Scientific Corporation | DXK |
| May 28, 2003 | K031148 | IN-VISION IMAGING SYSTEM Jomed, Inc. | DXK |
| Jan 14, 1994 | K934887 | 9750 ATHENA ETHERNET OPTION S & W Medico Teknik A/S, DK | DXK |
| May 15, 1992 | K913209 | ACCESSORY TO GENESIS III (GCFM) Biosound, Inc. | DXK |
| Jun 25, 1991 | K911384 | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 Endosonics Corp. | DXK |
| Apr 22, 1991 | K904832 | MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST Hewlett-Packard Co. | DXK |
| Feb 25, 1991 | K904978 | SOFTWARE PROGRAM USED W/PRISM PRODUCTS Prism Imaging, Inc. | DXK |
| Feb 25, 1991 | K904977 | CINE/VIEW PLUS - CARDIOLOGY WORKSTATION Prism Imaging, Inc. | DXK |
| Feb 25, 1991 | K904976 | CINE'VIEW - STRESS ECHO & IMAGE REVIEW Prism Imaging, Inc. | DXK |
| Feb 25, 1991 | K904975 | VISTA VIEWING STATION Prism Imaging, Inc. | DXK |
| Jan 31, 1991 | K910029 | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION Spacelabs, Inc. | DXK |
| Nov 16, 1990 | K903839 | INTERSPEC APOGEE Interspec, Inc. | DXK |
| Nov 9, 1990 | K903710 | WASHINGTON CARDIAC MONITOR Washington Biolab, Inc. | DXK |
| Oct 22, 1990 | K901592 | MODEL MD-5 DOPPLER D. E. Hokanson, Inc. | DXK |
| Sep 19, 1990 | K903414 | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN Echo Ultrasound | DXK |
| Sep 4, 1990 | K901658 | ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND Hitachi Medical Corp. of America | DXK |
| Sep 4, 1990 | K901657 | ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND Hitachi Medical Corp. of America | DXK |
| Jul 17, 1990 | K900350 | LEOCOR CORFLO(TM) PUMP Leocor, Inc. | DXK |
| Jul 9, 1990 | K901562 | CVIS INSIGHT IMAGING CATHETER Cardiovascular Imaging Systems, Inc. | DXK |
| Apr 2, 1990 | K900002 | DOPPLER OPTION FOR PLATINUM Philips Medical Systems North America, Inc. | DXK |
| Mar 22, 1990 | K895326 | EUB-165 Hitachi Medical Corp. of America | DXK |
| Feb 15, 1990 | K896543 | ULTRAMARK 7 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. | DXK |
| Jan 29, 1990 | K894370 | GENESIS III, (MOD. 7003/7004) Biosound, Inc. | DXK |
| Oct 19, 1989 | K894632 | MODEL SSH-140A ULTRASOUND IMAGING SYSTEM Toshiba America Medical Systems, In.C | DXK |
| Jun 22, 1989 | K885349 | SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. Sonotek Corp. | DXK |
| Feb 3, 1989 | K883845 | RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER Phoenix Imaging | DXK |
| Dec 12, 1988 | K883888 | CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. Advanced Biosearch Assn. | DXK |
| Apr 25, 1988 | K880217 | SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN. Ge Medical Systems Information Technologies | DXK |
| Apr 22, 1988 | K870878 | EUB-305 DIAGNOSTIC ULTRASOUND DEVICE Hitachi Medical Corp. of America | DXK |
| Mar 2, 1988 | K871555 | RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA. General Electric Co. | DXK |
| Feb 18, 1988 | K875272 | SONOLINE CF Siemens Medical Laboratories, Inc. | DXK |
| Feb 18, 1988 | K873762 | SERIES 77000 ULTRASOUND IMAGING SYSTEM Hewlett-Packard Co. | DXK |
| Feb 18, 1988 | K873032 | GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN Biosound, Inc. | DXK |
| Nov 6, 1987 | K871697 | GENESIS II Biosound, Inc. | DXK |
| Sep 4, 1987 | K863387 | MULTIPLE Del Mar Avionics | DXK |
| Jul 24, 1987 | K871400 | SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING Ge Medical Systems Information Technologies | DXK |
| Jun 24, 1987 | K863589 | MODEL 600 VASCULAR DUPLEX IMAGER Multigon Industries, Inc. | DXK |
| Feb 2, 1987 | K864657 | ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM Advanced Technology Laboratories, Inc. | DXK |
| Feb 2, 1987 | K862859 | EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND Biosound, Inc. | DXK |
| Dec 22, 1986 | K863965 | KENZ-ECG 102 Compumed, Inc. | DXK |
| Jul 9, 1986 | K861710 | MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY Johnson & Johnson Professionals, Inc. | DXK |
| Mar 25, 1986 | K855229 | CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM Vingmed, Inc. | DXK |
| Mar 12, 1986 | K853115 | SONOLAYER S, SSH-60A/SDS-60A Toshiba Medical Systems | DXK |
| Mar 10, 1986 | K852739 | SONOLINE SX ULTRASOUND SCANNER Siemens Medical Solutions USA, Inc. | DXK |
| Feb 20, 1986 | K854606 | SONOLAYER S, SSH-65A Toshiba Medical Systems | DXK |
| Oct 31, 1985 | K853769 | IRREGULAR CURVE TRACING REVISITION & DOPPLER Hewlett-Packard Co. | DXK |
| Oct 23, 1985 | K851901 | 750 SD ULTRASOUND SCANNER(MODIFICATION) Ultrasonix, Inc. | DXK |
| Sep 20, 1985 | K852543 | KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM Kontron Instruments, Inc. | DXK |
| Jul 12, 1985 | K851426 | ACCUCOM CARDIAC OUTPUT MONITOR Lawrence Medical Systems, Inc. | DXK |
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