Atlas FDA

DXK

78 FDA 510(k) clearances · Product code

94 daysmedian time to decision
207 days90th percentile
78clearances measured

FDA profile

Official device name
Echocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2330
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 1996: 2 · 1997: 2 · 1998: 1 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (K181042)Boston Scientific Corporation2018-05-17
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) (K160173)Boston Scientific Corporation2016-02-26
IN-VISION IMAGING SYSTEM (K031148)Jomed, Inc.2003-05-28
9750 ATHENA ETHERNET OPTION (K934887)S & W Medico Teknik A/S1994-01-14
ACCESSORY TO GENESIS III (GCFM) (K913209)Biosound, Inc.1992-05-15
CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600 (K911384)Endosonics Corp.1991-06-25
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST (K904832)Hewlett-Packard Co.1991-04-22
VISTA VIEWING STATION (K904975)Prism Imaging, Inc.1991-02-25
SOFTWARE PROGRAM USED W/PRISM PRODUCTS (K904978)Prism Imaging, Inc.1991-02-25
CINE'VIEW - STRESS ECHO & IMAGE REVIEW (K904976)Prism Imaging, Inc.1991-02-25
CINE/VIEW PLUS - CARDIOLOGY WORKSTATION (K904977)Prism Imaging, Inc.1991-02-25
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION (K910029)Spacelabs, Inc.1991-01-31
INTERSPEC APOGEE (K903839)Interspec, Inc.1990-11-16
WASHINGTON CARDIAC MONITOR (K903710)Washington Biolab, Inc.1990-11-09
MODEL MD-5 DOPPLER (K901592)D. E. Hokanson, Inc.1990-10-22
TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN (K903414)Echo Ultrasound1990-09-19
ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND (K901657)Hitachi Medical Corp. of America1990-09-04
ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND (K901658)Hitachi Medical Corp. of America1990-09-04
LEOCOR CORFLO(TM) PUMP (K900350)Leocor, Inc.1990-07-17
CVIS INSIGHT IMAGING CATHETER (K901562)Cardiovascular Imaging Systems, Inc.1990-07-09
DOPPLER OPTION FOR PLATINUM (K900002)Philips Medical Systems North America, Inc.1990-04-02
EUB-165 (K895326)Hitachi Medical Corp. of America1990-03-22
ULTRAMARK 7 ULTRASOUND SYSTEM (K896543)Advanced Technology Laboratories, Inc.1990-02-15
GENESIS III, (MOD. 7003/7004) (K894370)Biosound, Inc.1990-01-29
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM (K894632)Toshiba America Medical Systems, In.C1989-10-19
SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD. (K885349)Sonotek Corp.1989-06-22
RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER (K883845)Phoenix Imaging1989-02-03
CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. (K883888)Advanced Biosearch Assn.1988-12-12
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN. (K880217)Ge Medical Systems Information Technologies1988-04-25
EUB-305 DIAGNOSTIC ULTRASOUND DEVICE (K870878)Hitachi Medical Corp. of America1988-04-22
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA. (K871555)General Electric Co.1988-03-02
SONOLINE CF (K875272)Siemens Medical Laboratories, Inc.1988-02-18
GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN (K873032)Biosound, Inc.1988-02-18
SERIES 77000 ULTRASOUND IMAGING SYSTEM (K873762)Hewlett-Packard Co.1988-02-18
GENESIS II (K871697)Biosound, Inc.1987-11-06
MULTIPLE (K863387)Del Mar Avionics1987-09-04
SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING (K871400)Ge Medical Systems Information Technologies1987-07-24
MODEL 600 VASCULAR DUPLEX IMAGER (K863589)Multigon Industries, Inc.1987-06-24
EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND (K862859)Biosound, Inc.1987-02-02
ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM (K864657)Advanced Technology Laboratories, Inc.1987-02-02
KENZ-ECG 102 (K863965)Compumed, Inc.1986-12-22
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY (K861710)Johnson & Johnson Professionals, Inc.1986-07-09
CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM (K855229)Vingmed, Inc.1986-03-25
SONOLAYER S, SSH-60A/SDS-60A (K853115)Toshiba Medical Systems1986-03-12
SONOLINE SX ULTRASOUND SCANNER (K852739)Siemens Medical Solutions USA, Inc.1986-03-10
SONOLAYER S, SSH-65A (K854606)Toshiba Medical Systems1986-02-20
IRREGULAR CURVE TRACING REVISITION & DOPPLER (K853769)Hewlett-Packard Co.1985-10-31
750 SD ULTRASOUND SCANNER(MODIFICATION) (K851901)Ultrasonix, Inc.1985-10-23
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM (K852543)Kontron Instruments, Inc.1985-09-20
ACCUCOM CARDIAC OUTPUT MONITOR (K851426)Lawrence Medical Systems, Inc.1985-07-12
DEL MAR AVIONICS 8300 SECTOR IMAGER SYS (K844896)Del Mar Avionics1985-06-10
COLOR DOPPLER 880 (K843643)Irex Corp.1985-01-31
CARDIOSCAN - TM BEING APPLIED FOR (K841263)Interspec, Inc.1984-10-19
M-MODE ANALYSIS SYSTEM (K822425)User Resources, Inc.1982-10-04
FRANKLIN QUANTIC 1200 (K822236)Bruce Franklin, Inc.1982-08-31
ALLTEK BROMPTON ENCODER (K820145)Alltek Hospital Supplies , Ltd.1982-03-02
MAVIS C (K813002)Philips Medical Systems (Cleveland), Inc.1982-03-01
SKI 5000 (K812646)Smithkline Diagnostics, Inc.1981-11-16
ULTRA COM (K812209)Ultranamics, Inc.1981-11-16
ANGIOSCAN SPECTRUM ANALYZER (K812184)Unigon Industries, Inc.1981-09-09
SP-100-B SMALL PARTS SCANNER SYSTEM (K811595)Highstoy1981-08-12
DC-1 CARDIAC IMAGING MODULE (K811556)Diasonics, Inc.1981-07-10
MARK III ULTRASONIC SCANNING SYSTEM (K802917)Advanced Technology Laboratories, Inc.1981-01-16
PFIZONIC 100 ULTRASOUND SCANNER (K802529)Pfizer Medical Systems, Inc.1980-12-18
CONTIUOUS WAVE DOPPLER ULTRASOUND (K802670)American Edwards Laboratories1980-11-26
U.I. OCTOSON (K802030)Ausonics Pty , Ltd.1980-10-03
SINVISION LINEAR ARRAY REAL TIME (K800653)Kt Medical, Inc.1980-07-21
LINEAR ARRAY SCANNER (K800805)Philips Medical Systems (Cleveland), Inc.1980-07-21
ULTRA IMAGER (K800553)Honeywell, Inc.1980-07-21
HIGH STOY SMALL PARTS SCANNER #SP-100B (K800850)Highstoy1980-07-21
CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM (K801224)Cambridge Instruments, Inc.1980-06-26
IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA- (K792373)Ipco Corp.1980-02-13
SONACOLOR 6000 (K792540)Carolina Medical Electronics1980-01-17
CATHODE RAY TUBE DISPLAY MODEL 1340A (K780332)Hewlett-Packard Co.1978-03-22
HIGH-SPEED SECTOR SCANNING SSL-52H (K771292)Toshiba Medical Systems1977-08-16
ECHOCARDIOGRAPHY SYS., MODEL 3830 (K770755)Honeywell, Inc.1977-05-09
ECHOCARDIOGRAPHY SYS., MODEL 3860 (K770756)Honeywell, Inc.1977-05-09
PRIMUS INTER PARESECHOCARDIOGRAPHY SYS. (K770073)Rohe Scientific Corp.1977-01-25

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Every clearance here is in the API, with alerts when new ones post.