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

K222754ViewMate Multi Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., LTD
K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W)Philips Ultrasound LLC
K222441Ultrasound System 2300BK Medical Aps
K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40SuperSonic Imagine
K222198Exo Iris (El2001)Exo Imaging Inc.
K221599HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.
K221568KOLO Evolution XHD Series Ultrasound Diagnostic SystemKolo Medical (Suzhou) Co., Ltd
K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound SystemShenzhen Mindray Bio-medical Electronics Co., Ltd
K221500ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc
K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, ConsShenzhen Mindray Bio-Medical Electronics Co.,LTD
K221190ACUSON Juniper Diagnostic Ultrasound System And ACUSON Juniper Select Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.
K221148Vivid IqGE Medical Systems Ultrasound & Primary Care Diagnostics LLC
K221147Vivid T8, Vivid T9GE Medical Systems Ultrasound And Primary Care Diagnostics,
K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.
K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.

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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