System, Imaging, Pulsed Doppler, Ultrasonic

Product Code: IYN

Radiology Diagnostic Ultrasound Devices

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

Code of Federal Regulations: 892.1550


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as IYN

5328System, Imaging, Pulsed Doppler, UltrasonicUltrasonic Pulsed Doppler Imaging System.

Total Product Life Cycle (TPLC) Devices

5328System, Imaging, Pulsed Doppler, UltrasonicUltrasonic Pulsed Doppler Imaging System.

FDA Consensus Standards

System, Imaging, Pulsed Doppler, Ultrasonic [33222]21 CFR §892.1550 🔎
System, Imaging, Pulsed Doppler, Ultrasonic [37049]21 CFR §892.1550 🔎
System, Imaging, Pulsed Doppler, Ultrasonic [29909]21 CFR §892.1550 🔎
System, Imaging, Pulsed Doppler, Ultrasonic [37172]21 CFR §892.1550 🔎
System, Imaging, Pulsed Doppler, Ultrasonic [32093]21 CFR §892.1550 🔎
System, Imaging, Pulsed Doppler, Ultrasonic [32394]21 CFR §892.1550 🔎
System, Imaging, Pulsed Doppler, Ultrasonic [37039]21 CFR §892.1550 🔎
System, Imaging, Pulsed Doppler, Ultrasonic [33119]21 CFR §892.1550 🔎
System, Imaging, Pulsed Doppler, Ultrasonic [32393]21 CFR §892.1550 🔎

Pre-market Notifications for IYN

K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems
K212100KosmosEchoNous, Inc.
K2120216430 MyLabX75, 6430 MyLab XPro75Esaote S.p.A.
K211945V8 Diagnostic Ultrasound SystemSamsung Medison CO., LTD.
K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.
K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems
K211527Exo IrisExo Imaging Inc.
K211524LOGIQ E10s, LOGIQ FortisGE Healthcare
K211488LOGIQ E10GE Healthcare
K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., LTD
K211299X-CUBE 70Alpinion Medical Systems Co., Ltd.
K211232Apache Ultrasound SystemAco Healthcare Co,. Ltd.
K211216Vivid S60N / Vivid S70NGE Medical Systems Ultrasound And Primary Care Diagnostics
K210959RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison CO., LTD.
K210743ACUSON Redwood Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc

Global Unique Device Identification Database

00382830041799System, Imaging, Pulsed Doppler, Ultrasonic
00382830037679System, Imaging, Pulsed Doppler, Ultrasonic
00382830037181System, Imaging, Pulsed Doppler, Ultrasonic
00382830037068System, Imaging, Pulsed Doppler, Ultrasonic
00382830037051System, Imaging, Pulsed Doppler, Ultrasonic
00382830036757System, Imaging, Pulsed Doppler, Ultrasonic
00382830032223System, Imaging, Pulsed Doppler, Ultrasonic
00382830032117System, Imaging, Pulsed Doppler, Ultrasonic
00382830032094System, Imaging, Pulsed Doppler, Ultrasonic
00382830031530System, Imaging, Pulsed Doppler, Ultrasonic
20613994871002System, imaging, pulsed doppler, ultrasonic
20613994802259System, imaging, pulsed doppler, ultrasonic
20613994801511System, imaging, pulsed doppler, ultrasonic
00643169071995System, imaging, pulsed doppler, ultrasonic
00643169944268System, imaging, pulsed doppler, ultrasonic

Maude Adverse Events

ELITENATUS NEUROLOGY INCORPORATED2020-03-27
ELITENATUS NEUROLOGY INCORPORATED2020-03-20
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2020-03-16
LOGIQ E BT12GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)2020-03-12
AFFINITI 70 - 795210PHILIPS ULTRASOUND, INC2020-03-12
L12-3 COMPACT, ROHS - 989605412071PHILIPS ULTRASOUND, INC2020-03-10
EPIQ 7W - 795202PHILIPS ULTRASOUND, INC2020-03-04
EPIQ 7W - 795202PHILIPS ULTRASOUND, INC2020-03-04
3SC-RS PROBE W/VIVID IQGE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI)2020-02-27
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2020-02-20
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2020-02-20
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2020-02-19
EPIQ 5G - 795204PHILIPS ULTRASOUND, INC2020-02-19
VIVID E95GE VINGMED ULTRASOUND AS2020-02-19
AFFINITI 70 - 795210PHILIPS ULTRASOUND, INC2020-01-22
VIEWFLEX? PLUS ICE CATHETER INTERFACE MODULE FOR VIEWMATE Z INTRACARDIAC ULTRASOST. JUDE MEDICAL, INC.2020-01-02
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2019-12-24
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2019-12-11
LOGIQ P9GE ULTRASOUND KOREA, LTD.2019-11-21
EPIQ 5G - 795204PHILIPS ULTRASOUND, INC2019-11-12
VIEWMATE? Z ULTRASOUND CONSOLE WBATTERY ZS3ZONARE MEDICAL SYSTEMS, INC2019-11-06
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2019-10-31
IU22 DIAGNOSTIC ULTRASOUND SYSTEMPHILIPS ULTRASOUND, INC.2019-10-21
EPIQ 5G - 795204PHILIPS ULTRASOUND, INC2019-10-08
EVIS EUS ENDOSCOPIC ULTRASOUND CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-10-03
EVIS EUS ENDOSCOPIC ULTRASOUND CENTEROLYMPUS MEDICAL SYSTEMS CORP.2019-10-03
IE 33 ULTRASOUND SYSTEMPHILIPS ULTRASOUND, INC2019-09-04
VENUE R2SEEH102019-09-04
EPIQ DIAGNOSTIC ULTRASOUND SYSTEMPHILIPS ULTRASOUND, INC2019-08-30
EPIQ DIAGNOSTIC ULTRASOUND SYSTEMPHILIPS ULTRASOUND, INC2019-08-29
AFFINITI 70 - 795210PHILIPS ULTRASOUND, INC2019-08-22
AFFINITI 70 - 795210PHILIPS ULTRASOUND, INC2019-08-22
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2019-08-19
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2019-08-19
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2019-08-13
AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEMPHILIPS ULTRASOUND, INC2019-08-07
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2019-08-02
GE VT-DGE VINGMED ULTRASOUND AS2019-07-12
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2019-07-12
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2019-07-10
EPIQ 7C - 795201PHILIPS ULTRASOUND, INC2019-07-09
AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEMPHILIPS ULTRASOUND, INC2019-07-09
EPIQ 7G - 795200PHILIPS ULTRASOUND, INC2019-07-09
VSCAN EXTEND DUALGE VINGMED ULTRASOUND AS2019-06-26
SYSTEM, IMAGING, PULSED ECHO, ULTRASONICPHILIPS ULTRASOUND, INC2019-06-20
VOLUSON P8GE ULTRASOUND KOREA, LTD.2019-05-29
VOLUSON P8GE ULTRASOUND KOREA, LTD.2019-05-24
AFFINITI 70 DIAGNOSTIC ULTRASOUND SYSTEMPHILIPS ULTRASOUND, INC2019-04-29
LOGIQ E9SEE H102019-04-26
SYSTEM, IMAGING, PULSED ECHO, ULTRASONICPHILIPS ULTRASOUND, INC2019-04-24

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