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IYN

1,181 FDA 510(k) clearances · Product code

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RecordFirmDate
EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (K182857)Philips Ultrasound, Inc.2018-11-09
Vivid T8, Vivid T9 (K181934)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2018-11-06
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System (K182596)Canon Medical Systems Corporation2018-11-02
Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System (K182427)Canon Medical Systems Corporation2018-11-02
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 (K182679)Canon Medical Systems Corporation2018-10-31
Vivid E80, Vivid E90, Vivid E95 (K181685)GE Medical Systems Ultrasound and Primary Care Diagnostics2018-10-25
Xperius Ultrasound System (K182529)Philips Ultrasound, Inc.2018-10-23
Vivid S60N, Vivid S70N (K182450)GE Medical Systems Ultrasound and Primary Care Diagnostics2018-10-19
E-CUBE 8 (K181617)Alpinion Medical Systems Co., Ltd.2018-10-11
E-CUBE 12 (K181277)Alpinion Medical Systems Co., Ltd.2018-09-28
LOGIQ P9; LOGIQ P7 (K181783)GE Healthcare2018-09-20
BenQ Diagnostic Ultrasound System (K181313)Qisda Corporation2018-08-27
CBit Series Digital Color Doppler Ultrasound System (K180974)CHISON Medical Technologies Co., Ltd.2018-08-17
Ultrasound Scanner System bk2300 (K180737)Bk Medical Aps2018-08-01
TE7/TE5 Diagnostic Ultrasound System (K180912)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-07-30
EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System (K181485)Philips Ultrasound, Inc.2018-07-27
ARIETTA 65 (K181376)Hitachi Healthcare Americas Corporation2018-07-18
NTU-USB Ultrasound USB Box (K173486)National Taiwan University2018-07-11
Transcranial Doppler Ultrasound System (K173801)Shenzhen Delica Medical Equipment Co., Ltd.2018-07-11
Vscan Extend (K180995)GE Medical Systems Ultrasound and Primary Care Diagnostics2018-06-25
ACUSON SC2000 Diagnostic Ultrasound System (K181098)Siemens Medical Solutions USA, Inc.2018-05-31
AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 (K180572)Supersonic Imagine2018-05-29
Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System (K180862)Edan Instruments, Inc.2018-05-24
NeuralBot (K180455)Neural Analytics, Inc.2018-05-22
Clarius Ultrasound Scanner (K180799)Clarius Mobile Health Corp.2018-05-14
Ventripoint Medical System Plus (VMS+) (K173810)Ventripoint Diagnostics , Ltd.2018-05-14
HS40 Diagnostic Ultrasound System (K180409)Samsung Medison Co., Ltd.2018-05-11
Navi e/Navi s/Navi X Diagnostic Ultrasound System (K180461)Shenzhen Wisonic Medical Technology Co. , Ltd.2018-05-09
Venue (K180599)GE Medical Systems Ultrasound and Primary Care Diagnostics2018-05-02
Viamo c100 TUS-VC100 Diagnostic Ultrasound System (K173962)Toshibamedical Systems Corporation2018-04-20
SonoSite iViz Ultrasound System (K180704)FUJIFILM Sonosite, Inc.2018-04-13
U60 Diagnostic Ultrasound System (K180408)Edan Instruments, Inc.2018-04-13
Voluson P6 and Voluson P8 (K180535)GE Healthcare2018-03-29
Voluson S8/ Voluson S10/ Voluson S10 Expert (K180374)GE Healthcare2018-03-13
HS70A Diagnostic Ultrasound System (K173713)Samsung Medison Co., Ltd.2018-03-08
ALOKA ARIETTA 850 (K173739)Hitachi Healthcare Americas Corporation2018-02-28
Ultrasound System 1300 (K173569)Bk Medical Aps2018-02-23
WS80A Diagnostic Ultrasound System (K173513)Samsung Medison Co., Ltd.2018-02-20
ACUSON X800 Diagnostic Ultrasound System (K180067)Siemens Medical Solutions USA, Inc.2018-02-07
RS85 Diagnostic Ultrasound System (K173204)Samsung Medison Co., Ltd.2018-02-05
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System (K173981)Siemens Medical Solutions USA, Inc. Ultrasound Group2018-02-02
ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System (K173957)Siemens Medical Solutions USA, Inc.2018-02-01
ACUSON P600 Diagnostic Ultrasound System (K180039)Siemens Medical Solutions USA, Inc.2018-02-01
6440 Ultrasound System (K173291)Esaote, S.p.A.2018-01-12
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 (K173090)Toshibamedical Systems Corporation2018-01-11
Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (K173021)Supersonic Imagine2018-01-09
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic (K173471)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-01-08
Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System (K172860)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-01-02
Clover 50/Clover60/Clover70 Diagnostic Ultrasound System (K163712)Shenzhen Wisonic Medical Technology Co. , Ltd.2018-01-02
LOGIQ E10 (K173555)GE Healthcare2017-12-20
E-CUBE 8 (K172732)Alpinion Medical Systems Co., Ltd.2017-12-14
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System (K173369)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2017-12-13
Xario 200 Diagnostic Ultrasound System V6.0 (K172276)Toshibamedical Systems Corporation2017-12-12
Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System (K173000)Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2017-12-07
P20 Series Digital Color Doppler Ultrasound System (K172993)Sonoscape Medical Corp.2017-12-05
P10 Series Digital Color Doppler Ultrasound System (K173058)Sonoscape Medical Corp.2017-12-01
U50 Diagnostic Ultrasound System (K173003)Edan Instruments, Inc.2017-11-15
Dolphin/IQ and Dolphin/4D (K170859)Viasonix , Ltd.2017-11-14
UltraVision 2 Diagnostic Ultrasound System (K173265)Winprobe Corporation2017-11-07
Vivid E80, Vivid E90, Vivid E95 (K173341)GE Medical Systems2017-11-02
ALOKA ARIETTA 850 (K171708)Hitachi Healthcare Americas Corporation2017-10-31
C5 Diagnostic Ultrasound System (K171926)Guangzhou Sonostar Technologies Co., Ltd.2017-10-27
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound (K172970)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-10-25
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System (K171579)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-10-18
SONON Ultrasound Imaging System, Model: 300L (K170085)Healcerion Co., Ltd.2017-10-12
LinkQuest Diagnostic Ultrasound System model SQ860 (K172059)Linkquest, Inc.2017-10-05
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System (K172607)Philips Health Care2017-10-04
Voluson E6, Voluson E8, Voluson E10 (K172342)GE Healthcare2017-09-29
U2 Diagnostic Ultrasound System (K172380)Edan Instruments, Inc.2017-09-29
ZS3 Ultrasound System, z.one pro Ultrasound System (K171891)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-09-21
S60 Series Digital Color Doppler Ultrasound System (K172082)Sonoscape Medical Corp.2017-09-21
Clarius Ultrasound System (K172385)Clarius Mobile Health Corp.2017-09-14
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (K171233)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2017-09-12
Poseidon Ultrasound System (K163510)Butterfly Network, Inc.2017-09-06
DUS-7000 Digital Color Doppler Ultrasound System (K172055)Advanced Instrumentations, Inc.2017-08-31
RS80A Diagnostic Ultrasound System (K171048)Samsung Medison Co., Ltd.2017-08-24
Acclarix AX4 Diagnostic Ultrasound System (K171900)Edan Instruments, Inc.2017-08-18
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems (K172162)Siemens Healthcare2017-08-16
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System (K172374)Siemens Medical Solutions USA, Inc.2017-08-15
SmartUs EXT-1M/3M (K163121)Telemed2017-08-10
WS80A Diagnostic Ultrasound System (K171070)Samsung Medison Co., Ltd.2017-08-09
HS40 Diagnostic Ultrasound System (K172129)Samsung Medison Co., Ltd.2017-08-08
U-Lite EXP (K171164)Sonoscanner2017-08-03
P50 Series Digital Color Doppler Ultrasound System (K170999)Sonoscape Medical Corp.2017-07-12
AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems (K171105)Supersonic Imagine2017-07-11
P60 Series Digital Color Doppler Ultrasound System (K171000)Sonoscape Medical Corp.2017-07-11
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System (K171034)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-07-10
Site~Rite Halcyon Diagnostic Ultrasound System (K170870)Chison Medical Imaging Co., Ltd.2017-07-06
Venue (K170714)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017-06-21
Vivid S60N, Vivid S70N (K170878)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2017-06-14
SonoSite X-Porte Ultrasound System (K171437)FUJIFILM Sonosite, Inc.2017-06-12
Vivid E80, Vivid E90, Vivid E95 (K170823)GE Medical Systems Ultrasound and Primary Care Diagnostics2017-06-12
SonoBook Series Diagnostic Ultrasound System (K170374)Chison Medical Imaging Co., Ltd.2017-06-06
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 (K163702)Toshibamedical Systems Corporation2017-05-30
ARIETTA PRECISION (K163505)Hitachi , Ltd.2017-05-30
TRINITY/3D PROSTATE SUITE (K170521)Koelis2017-05-30
E5 Series Digital Color Doppler Ultrasound System (K170303)Sonoscape Medical Corp.2017-05-19
Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley (K170078)Medisono, LLC2017-05-17
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System (K163690)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2017-04-20
Interson USB Ultrasound System (K163443)Interson Corporation2017-04-13
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