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IYN

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

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RecordFirmDate
Voluson SWIFT, Voluson SWIFT+ (K201828)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-10-11
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 (K201972)Canon Medical Systems Corporation2020-10-08
Butterfly iQ Ultrasound System (K202406)Butterfly Network, Inc.2020-09-16
Vivid iq (K200708)Ge Medical Systems Ultrasound And2020-09-09
Vivid T8, Vivid T9 (K200851)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-09-09
EPIQ Series Diagnostic Ultrasound Systems (K202216)Philips Ultrasound, Inc.2020-09-02
Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System (K202160)FUJIFILM Sonosite, Inc.2020-09-01
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System (K201693)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-08-21
XBit Series Digital Color Doppler Ultrasound System (K200780)CHISON Medical Technologies Co., Ltd.2020-08-05
S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System (K201059)Sonoscape Medical Corp.2020-07-30
Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous (K200643)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-07-24
Vivid E80/ Vivid E90/ Vivid E95 (K200743)Ge Medical Systems Ultrasound And2020-07-23
Vivid S60N, Vivid S70N (K200497)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-07-16
X-Cube 70 (K200450)Alpinion Medical Systems Co., Ltd.2020-07-10
X-Cube 90 (K200449)Alpinion Medical Systems Co., Ltd.2020-07-10
Terason uSmart 3200T Plus Ultrasound System (K201633)Teratech Corporation2020-07-02
Versana Premier (K200138)Ge Medical Systems Ultrasound And2020-07-01
ACUSON Sequoia Diagnostic Ultrasound System (K201462)Siemens Medical Solutions USA, Inc.2020-06-24
Versana Active (K200998)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-06-11
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System (K200979)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-05-28
ACUSON Juniper Diagnostic Ultrasound System (K201130)Siemens Medical Solutions USA, Inc.2020-05-26
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System (K192879)Edan Instruments, Inc.2020-05-21
Sonosite PX Ultrasound System (K200964)FUJIFILM Sonosite, Inc.2020-05-08
HS70A Diagnostic Ultrasound System (K200699)Samsung Medison Co., Ltd.2020-05-07
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System (K201012)Philips Ultrasound, Inc.2020-05-01
Acuson SC2000 Diagnostic Ultrasound System (K200585)Siemens Medical Solutions USA, Inc.2020-04-22
LOGIQ E10 (K200158)GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2020-04-17
ACUSON Sequoia Diagnostic Ultrasound System (K200707)Siemens Medical Solutions USA, Inc.2020-04-15
ACUSON Freestyle Diagnostic Ultrasound System (K200644)Siemens Medical Solutions USA, Inc.2020-04-10
MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System (K200001)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-04-09
Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System (K200411)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-04-08
HS40 Diagnostic Ultrasound System (K200339)Samsung Medison Co., Ltd.2020-04-07
Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System (K200251)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2020-04-02
LOGIQ E10s (K200119)GE Medical Systems Ultrasound and Primary Care Diagnostics2020-04-01
KOSMOS (K193518)EchoNous, Inc.2020-03-26
SonoVision Ultrasound Imaging System (K192388)Tissue Differentiation Intelligence, LLC2020-03-12
EPIQ Diagnostic Ultrasound System (K200304)Philips Ultrasound, Inc.2020-03-06
Leltek Ultrasound Imaging System (K191235)Leltek, Inc.2020-02-12
Paragon XHD Diagnostic Ultrasound System (K191347)Shenzhen Wisonic Medical Technology Co. , Ltd.2020-02-07
ACUSON Sequoia Diagnostic Ultrasound System (K193257)Siemens Medical Solutions USA, Inc.2020-01-31
Terason uSmart3200T Ultrasound System (K193510)Teratech Corporation2020-01-28
VINNO 8, VINNO 6, VINNO 5 (K190120)Vinno Technology (Suzhou) Co.,Ltd2020-01-23
RS85 Diagnostic Ultrasound System (K192903)Samsung Medison Co., Ltd.2020-01-06
ZS3 and z.one pro Ultrasound Systems (K192410)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2019-12-19
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System (K192152)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2019-12-13
HS50/HS60 Diagnostics Ultrasound System (K192505)Samsung Medison Co., Ltd.2019-12-12
HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System (K192319)Samsung Medison Co., Ltd.2019-12-10
6450 Ultrasound system (K192157)Esaote, S.p.A.2019-11-22
Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems (K191007)Supersonic Imagine2019-10-25
ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System (K192835)Siemens Medical Solutions USA, Inc.2019-10-22
ExactVu High Resolution Micro-Ultrasound System (K192303)Exact Imaging, Inc.2019-10-01
RS80 EVO Diagnostic Ultrasound System (K192030)Samsung Medison Co., Ltd.2019-09-19
Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 (K191663)Canon Medical Systems Corporation2019-09-18
InnoSight Diagnostic Ultrasound System (K192254)Qisda Corporation2019-09-18
Lumify Diagnostic Ultrasound System (K192226)Philips Health Care2019-09-06
Clarius Ultrasound Scanner (K192107)Clarius Mobile Health Corp.2019-08-29
Voluson E6, Voluson E8, Voluson E10 (K192159)GE Healthcare2019-08-29
ACUSON P200 Diagnostic Ultrasound System (K191922)Siemens Medical Solutions USA, Inc.2019-08-15
Versana Balance (K191792)GE Medical Systems Ultrasound and Primary Care Diagnostics2019-08-09
Versana Active (K191798)GE Medical Systems Ultrasound and Primary Care Diagnostics2019-08-09
ARIETTA 750 (K191233)Hitachi Healthcare Americas2019-08-09
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 (K191467)Canon Medical Systems Corporation2019-07-19
Full Digital Colour Doppler Ultrasonic Diagnostic System (K183041)Wuhan Zoncare Bio-medical Electronics Co., Ltd.2019-07-10
Transcranial Doppler Ultrasound System (K190228)Shenzhen Delica Medical Equipment Co., Ltd.2019-06-13
RS85 Diagnostic Ultrasound System (K191115)Samsung Medison Co., Ltd.2019-06-12
HS40 Diagnostic Ultrasound System (K191055)Samsung Medison Co., Ltd.2019-06-12
7410 Ultrasound System (MyLabSigma) (K191072)Esaote, S.p.A.2019-06-10
HERA I10 Diagnostic Ultrasound System (K190444)Samsung Medison Co., Ltd.2019-05-22
Dolphin/IQ, Dolphin/4D and Dolphin/MAX (K191023)Viasonix , Ltd.2019-05-16
6400 Ultrasound System (MyLabX6, MyLabX7) (K190989)Esaote, S.p.A.2019-05-10
ExactVu High Resolution Micro-Ultrasound System (K190995)Exact Imaging, Inc.2019-05-10
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System (K183660)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2019-04-09
TCD-X (K182175)Atys2019-04-05
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System (K183377)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2019-04-04
ARIETTA 50 (K190248)Hitachi Healthcare Americas2019-04-02
7400 Ultrasound Systems (K190447)Navigant Consulting - on Behalf of Esaote S.P.A.2019-04-01
ACUSON S3000, S2000 Diagnostic Ultrasound System (K183575)Siemens Healthineers2019-03-20
FUJIFILM Sonosite Vevo MD Imaging System (K190476)FUJIFILM Sonosite, Inc.2019-03-15
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System (K190206)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2019-03-08
Imagio Ultrasound Imaging System (K182628)Seno Medical Instruments, Inc.2019-03-05
RS85 Diagnostic Ultrasound System (K182932)Samsung Medison Co., Ltd.2019-02-15
SonoSite SII Ultrasound System (K183235)FUJIFILM Sonosite, Inc.2019-02-07
X5 Series Digital Color Doppler Ultrasound System (K182648)Sonoscape Medical Corp.2019-01-29
Venue GO (K183362)GE Medical Systems Ultrasound and Primary Care Diagnostics2019-01-28
Aloka Arietta 850 (K183456)Hitachi Healthcare Americas2019-01-28
E-CUBE i7 (K182594)Alpinion Medical Systems Co., Ltd.2019-01-24
HM70A Diagnostic Ultrasound System (K182894)Samsung Medison Co., Ltd.2019-01-22
DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System (K182636)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2019-01-10
DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System (K181637)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2019-01-09
HS30 Diagnostic Ultrasound System (K182632)Samsung Medison Co., Ltd.2019-01-08
minisono (K182845)Alpinion Medical Systems Co., Ltd.2018-12-27
Color Doppler Ultrasound System; Model: mEye1 and mEye2 (K182165)Shenzhen Well.D Medical Electronics Co., Ltd.2018-12-20
HERA W10 Diagnostic Ultrasound System (K182595)Samsung Medison Co., Ltd.2018-12-18
Vivid iq (K181727)GE Medical Systems Ultrasound and Primary Care Diagnostics2018-12-06
6420 Ultrasound System (K183191)Esaote, S.p.A.2018-12-04
HS50 / HS60 Diagnostic Ultrasound System (K181336)Samsung Medison Co., Ltd.2018-12-04
Versana Premier (K182277)GE Medical Systems Ultrasound and Primary Care Diagnostics2018-11-21
Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System (K182715)Shenzhen Wisonic Medical Technology Co. , Ltd.2018-11-20
Voluson E6, Voluson E8, Voluson E10 (K181985)GE Healthcare2018-11-15
Z6 Diagnostic Ultrasound System (K182603)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2018-11-14
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