Echocardiograph

Product Code: DXK

Cardiovascular Diagnostic Ultrasound Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 870.2330


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as DXK

818EchocardiographEchocardiograph.

Total Product Life Cycle (TPLC) Devices

818EchocardiographEchocardiograph.

Pre-market Notifications for DXK

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific Corporation
K160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific Corporation
K9348879750 ATHENA ETHERNET OPTIONS & W MEDICO TEKNIK A/S
K913209ACCESSORY TO GENESIS III (GCFM)BIOSOUND, INC.
K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600ENDOSONICS CORP.
K910029PATIENT CARE MANAGEMENT SYSTEM MODIFICATIONSPACELABS, INC.
K904976CINE'VIEW - STRESS ECHO & IMAGE REVIEWPRISM IMAGING, INC.
K904977CINE/VIEW PLUS - CARDIOLOGY WORKSTATIONPRISM IMAGING, INC.
K904978SOFTWARE PROGRAM USED W/PRISM PRODUCTSPRISM IMAGING, INC.
K904975VISTA VIEWING STATIONPRISM IMAGING, INC.
K904832MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYSTHEWLETT-PACKARD CO.
K903839INTERSPEC APOGEEINTERSPEC, INC.
K903710WASHINGTON CARDIAC MONITORWASHINGTON BIOLAB, INC.
K903414TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMNECHO ULTRASOUND
K901658ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUNDHITACHI MEDICAL CORP. OF AMERICA

Global Unique Device Identification Database

00817065021464Echocardiograph
00817065021426Echocardiograph
00817065021372Echocardiograph
00817065021365Echocardiograph
00817065021358Echocardiograph
00817065021334Echocardiograph
00817065021327Echocardiograph
00817065021310Echocardiograph
00817065021303Echocardiograph
08714729982500Echocardiograph

Maude Adverse Events

ULTRA ICE PLUS - PIBOSTON SCIENTIFIC CORPORATION2019-09-23
ULTRA ICE PLUS?BOSTON SCIENTIFIC - COSTA RICA (COYOL)2018-05-22
ULTRA ICE PLUS?BOSTON SCIENTIFIC - COSTA RICA (COYOL)2018-03-22
ULTRA ICE PLUS?BOSTON SCIENTIFIC - COSTA RICA (COYOL)2018-03-15
ULTRA ICE PLUS?BOSTON SCIENTIFIC - COSTA RICA (COYOL)2018-03-06
INTRACARDIAC ECHO CATHETERABBOTT2017-09-25
ULTRA ICE PLUS?BOSTON SCIENTIFIC - COSTA RICA (COYOL)2017-08-15
ULTRA ICE PLUS?BOSTON SCIENTIFIC - COSTA RICA (COYOL)2017-06-06
ULTRA ICE PLUS?BOSTON SCIENTIFIC - COSTA RICA (COYOL)2017-06-06
GE HEALTHCARE 6TC TEE PROBEGE VINGMED ULTRASOUND AS2012-08-07
GE MEDICAL SYSTEMSGE MEDICAL SYSTEMS2006-01-09
GE MEDICALGE MEDICAL2005-09-21
*ECHOCARDIOGRAPHY EQUIPMENTUNK1998-12-16
UNKECHO-CARDIOGRAPH ELECTRODEUNK1997-07-29
HP ECHOTRANSDUCERHEWLETT PACKARD1997-07-01
VINGMEDDIASONICS1996-09-10
ECHOCARDIOGRAPH DEVICEUNKNOWN1996-03-19
COLOR DOPPLER ULTRASOUNDHEWLETT PACKARD CO.1994-01-10

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