FDA Product Code
FDA Product Code DXK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2330
510(k) Clearances — 78 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K181042 | Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter | Boston Scientific Corporation | 2018-05-17 | Special | PDF ↗ |
| 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 | Special | PDF ↗ |
| K031148 | IN-VISION IMAGING SYSTEM | Jomed, Inc. | 2003-05-28 | Special | PDF ↗ |
| K934887 | 9750 ATHENA ETHERNET OPTION | S & W Medico Teknik A/S | 1994-01-14 | Traditional | PDF ↗ |
| K913209 | ACCESSORY TO GENESIS III (GCFM) | Biosound, Inc. | 1992-05-15 | Traditional | PDF ↗ |
| K911384 | CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 | Endosonics Corp. | 1991-06-25 | Traditional | PDF ↗ |
| K904832 | MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST | Hewlett-Packard Co. | 1991-04-22 | Traditional | PDF ↗ |
| K904978 | SOFTWARE PROGRAM USED W/PRISM PRODUCTS | Prism Imaging, Inc. | 1991-02-25 | Traditional | PDF ↗ |
| K904977 | CINE/VIEW PLUS - CARDIOLOGY WORKSTATION | Prism Imaging, Inc. | 1991-02-25 | Traditional | PDF ↗ |
| K904976 | CINE'VIEW - STRESS ECHO & IMAGE REVIEW | Prism Imaging, Inc. | 1991-02-25 | Traditional | PDF ↗ |
| K904975 | VISTA VIEWING STATION | Prism Imaging, Inc. | 1991-02-25 | Traditional | PDF ↗ |
| K910029 | PATIENT CARE MANAGEMENT SYSTEM MODIFICATION | Spacelabs, Inc. | 1991-01-31 | Traditional | PDF ↗ |
| K903839 | INTERSPEC APOGEE | Interspec, Inc. | 1990-11-16 | Traditional | PDF ↗ |
| K903710 | WASHINGTON CARDIAC MONITOR | Washington Biolab, Inc. | 1990-11-09 | Traditional | PDF ↗ |
| K901592 | MODEL MD-5 DOPPLER | D. E. Hokanson, Inc. | 1990-10-22 | Traditional | PDF ↗ |
| K903414 | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN | Echo Ultrasound | 1990-09-19 | Traditional | PDF ↗ |
| K901657 | ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND | Hitachi Medical Corp. of America | 1990-09-04 | Traditional | PDF ↗ |
| K901658 | ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND | Hitachi Medical Corp. of America | 1990-09-04 | Traditional | PDF ↗ |
| K900350 | LEOCOR CORFLO(TM) PUMP | Leocor, Inc. | 1990-07-17 | Traditional | PDF ↗ |
| K901562 | CVIS INSIGHT IMAGING CATHETER | Cardiovascular Imaging Systems, Inc. | 1990-07-09 | Traditional | PDF ↗ |
| K900002 | DOPPLER OPTION FOR PLATINUM | Philips Medical Systems North America, Inc. | 1990-04-02 | Traditional | PDF ↗ |
| K895326 | EUB-165 | Hitachi Medical Corp. of America | 1990-03-22 | Traditional | PDF ↗ |
| K896543 | ULTRAMARK 7 ULTRASOUND SYSTEM | Advanced Technology Laboratories, Inc. | 1990-02-15 | Traditional | PDF ↗ |
| K894370 | GENESIS III, (MOD. 7003/7004) | Biosound, Inc. | 1990-01-29 | Traditional | PDF ↗ |
| K894632 | MODEL SSH-140A ULTRASOUND IMAGING SYSTEM | Toshiba America Medical Systems, In.C | 1989-10-19 | Traditional | PDF ↗ |
| K885349 | SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. | Sonotek Corp. | 1989-06-22 | Traditional | PDF ↗ |
| K883845 | RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER | Phoenix Imaging | 1989-02-03 | Traditional | PDF ↗ |
| K883888 | CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. | Advanced Biosearch Assn. | 1988-12-12 | Traditional | PDF ↗ |
| K880217 | SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN. | Ge Medical Systems Information Technologies | 1988-04-25 | Traditional | PDF ↗ |
| K870878 | EUB-305 DIAGNOSTIC ULTRASOUND DEVICE | Hitachi Medical Corp. of America | 1988-04-22 | Traditional | PDF ↗ |
| K871555 | RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA. | General Electric Co. | 1988-03-02 | Traditional | PDF ↗ |
| K873762 | SERIES 77000 ULTRASOUND IMAGING SYSTEM | Hewlett-Packard Co. | 1988-02-18 | Traditional | PDF ↗ |
| K873032 | GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN | Biosound, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K875272 | SONOLINE CF | Siemens Medical Laboratories, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K871697 | GENESIS II | Biosound, Inc. | 1987-11-06 | Traditional | PDF ↗ |
| K863387 | MULTIPLE | Del Mar Avionics | 1987-09-04 | Traditional | PDF ↗ |
| K871400 | SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING | Ge Medical Systems Information Technologies | 1987-07-24 | Traditional | PDF ↗ |
| K863589 | MODEL 600 VASCULAR DUPLEX IMAGER | Multigon Industries, Inc. | 1987-06-24 | Traditional | PDF ↗ |
| K864657 | ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM | Advanced Technology Laboratories, Inc. | 1987-02-02 | Traditional | PDF ↗ |
| K862859 | EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND | Biosound, Inc. | 1987-02-02 | Traditional | PDF ↗ |
| K863965 | KENZ-ECG 102 | Compumed, Inc. | 1986-12-22 | Traditional | PDF ↗ |
| K861710 | MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY | Johnson & Johnson Professionals, Inc. | 1986-07-09 | Traditional | PDF ↗ |
| K855229 | CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM | Vingmed, Inc. | 1986-03-25 | Traditional | PDF ↗ |
| K853115 | SONOLAYER S, SSH-60A/SDS-60A | Toshiba Medical Systems | 1986-03-12 | Traditional | PDF ↗ |
| K852739 | SONOLINE SX ULTRASOUND SCANNER | Siemens Medical Solutions USA, Inc. | 1986-03-10 | Traditional | PDF ↗ |
| K854606 | SONOLAYER S, SSH-65A | Toshiba Medical Systems | 1986-02-20 | Traditional | PDF ↗ |
| K853769 | IRREGULAR CURVE TRACING REVISITION & DOPPLER | Hewlett-Packard Co. | 1985-10-31 | Traditional | PDF ↗ |
| K851901 | 750 SD ULTRASOUND SCANNER(MODIFICATION) | Ultrasonix, Inc. | 1985-10-23 | Traditional | PDF ↗ |
| K852543 | KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM | Kontron Instruments, Inc. | 1985-09-20 | Traditional | PDF ↗ |
| K851426 | ACCUCOM CARDIAC OUTPUT MONITOR | Lawrence Medical Systems, Inc. | 1985-07-12 | Traditional | PDF ↗ |
| K844896 | DEL MAR AVIONICS 8300 SECTOR IMAGER SYS | Del Mar Avionics | 1985-06-10 | Traditional | PDF ↗ |
| K843643 | COLOR DOPPLER 880 | Irex Corp. | 1985-01-31 | Traditional | PDF ↗ |
| K841263 | CARDIOSCAN - TM BEING APPLIED FOR | Interspec, Inc. | 1984-10-19 | Traditional | PDF ↗ |
| K822425 | M-MODE ANALYSIS SYSTEM | User Resources, Inc. | 1982-10-04 | Traditional | PDF ↗ |
| K822236 | FRANKLIN QUANTIC 1200 | Bruce Franklin, Inc. | 1982-08-31 | Traditional | PDF ↗ |
| K820145 | ALLTEK BROMPTON ENCODER | Alltek Hospital Supplies , Ltd. | 1982-03-02 | Traditional | PDF ↗ |
| K813002 | MAVIS C | Philips Medical Systems (Cleveland), Inc. | 1982-03-01 | Traditional | PDF ↗ |
| K812646 | SKI 5000 | Smithkline Diagnostics, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K812209 | ULTRA COM | Ultranamics, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K812184 | ANGIOSCAN SPECTRUM ANALYZER | Unigon Industries, Inc. | 1981-09-09 | Traditional | PDF ↗ |
| K811595 | SP-100-B SMALL PARTS SCANNER SYSTEM | Highstoy | 1981-08-12 | Traditional | PDF ↗ |
| K811556 | DC-1 CARDIAC IMAGING MODULE | Diasonics, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K802917 | MARK III ULTRASONIC SCANNING SYSTEM | Advanced Technology Laboratories, Inc. | 1981-01-16 | Traditional | PDF ↗ |
| K802529 | PFIZONIC 100 ULTRASOUND SCANNER | Pfizer Medical Systems, Inc. | 1980-12-18 | Traditional | PDF ↗ |
| K802670 | CONTIUOUS WAVE DOPPLER ULTRASOUND | American Edwards Laboratories | 1980-11-26 | Traditional | PDF ↗ |
| K802030 | U.I. OCTOSON | Ausonics Pty , Ltd. | 1980-10-03 | Traditional | PDF ↗ |
| K800653 | SINVISION LINEAR ARRAY REAL TIME | Kt Medical, Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K800805 | LINEAR ARRAY SCANNER | Philips Medical Systems (Cleveland), Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K800850 | HIGH STOY SMALL PARTS SCANNER #SP-100B | Highstoy | 1980-07-21 | Traditional | PDF ↗ |
| K800553 | ULTRA IMAGER | Honeywell, Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K801224 | CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM | Cambridge Instruments, Inc. | 1980-06-26 | Traditional | PDF ↗ |
| K792373 | IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA- | Ipco Corp. | 1980-02-13 | Traditional | PDF ↗ |
| K792540 | SONACOLOR 6000 | Carolina Medical Electronics | 1980-01-17 | Traditional | PDF ↗ |
| K780332 | CATHODE RAY TUBE DISPLAY MODEL 1340A | Hewlett-Packard Co. | 1978-03-22 | Traditional | PDF ↗ |
| K771292 | HIGH-SPEED SECTOR SCANNING SSL-52H | Toshiba Medical Systems | 1977-08-16 | Traditional | PDF ↗ |
| K770756 | ECHOCARDIOGRAPHY SYS., MODEL 3860 | Honeywell, Inc. | 1977-05-09 | Traditional | PDF ↗ |
| K770755 | ECHOCARDIOGRAPHY SYS., MODEL 3830 | Honeywell, Inc. | 1977-05-09 | Traditional | PDF ↗ |
| K770073 | PRIMUS INTER PARESECHOCARDIOGRAPHY SYS. | Rohe Scientific Corp. | 1977-01-25 | Traditional | PDF ↗ |
Product code DXK · Class II · Cardiovascular. Data: openFDA.