ClearanceBrief
Panels › Radiology › Product code IYN · Class 2

System, Imaging, Pulsed Doppler, Ultrasonic

Regulation 892.1550

55510(k)s in 12 months (1,189 all time)
10recalls in 12 months (300 all time)
288recalls that name a 510(k)
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Top companies in IYN

Company510(k)sRecalls
Philips Ultrasound5293
Siemens Medical Solutions USA, Inc.7562
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.850
Samsung Medison Co., Ltd.700
GE Healthcare5215
GE Medical Systems Ultrasound and Primary Care Diagnostics620
Esaote, S.p.A.347
Alpinion Medical Systems Co., Ltd.250
FUJIFILM Sonosite, Inc.250
General Electric Co.230
Decided510(k)Device and applicantCode
Oct 28, 2022K222191Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
Supersonic Imagine, FR
IYN
Oct 25, 2022K222365Leltek Ultrasound Imaging System (Model: LU700 Series)
Leltek, Inc., TW
IYN
Oct 14, 2022K221093X-CUBE 70, X-CUBE 90
Alpinion Medical Systems Co., Ltd., KR
IYN
Oct 13, 2022K220857X-CUBE 50, X-CUBE 60
Alpinion Medical Systems Co., Ltd., KR
IYN
Oct 13, 2022K211321Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL)
Guangzhou Sonostar Technologies Co., Ltd., CN
IYN
Oct 11, 2022K220169SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireles
Bionet Co., Ltd., KR
IYN
Sep 29, 2022K221496Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Sep 29, 2022K221300Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Con
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Sep 27, 2022K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ul
Philips Ultrasound, LLC
IYN
Sep 15, 2022K221089P12 Elite Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Sep 13, 2022K221140P20 Elite Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp., CN
IYN
Sep 12, 2022K221568KOLO Evolution XHD Series Ultrasound Diagnostic System
Kolo Medical (Suzhou) Co., Ltd., CN
IYN
Aug 22, 2022K221599HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Aug 16, 2022K221190ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Jul 22, 2022K220882Vivid E80, Vivid E90, Vivid E95
Ge Medical Systems Ultrasound And
IYN
Jul 18, 2022K221148Vivid iq
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
IYN
Jul 18, 2022K221147Vivid T8, Vivid T9
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jul 15, 2022K220619Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jul 8, 2022K213009Transcranial Doppler Ultrasound System
Shenzhen Delica Medical Equipment Co., Ltd., CN
IYN
Jun 29, 2022K220975V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 27, 2022K220851Venue
GE Medical Systems
IYN
Jun 27, 2022K220848Venue Fit
GE Medical Systems
IYN
Jun 23, 2022K220993Ultrasound System SONIMAGE MX1
Konica Minolta, Inc., JP
IYN
Jun 21, 2022K220800Venue Go
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Jun 17, 2022K221117RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Jun 14, 2022K221500ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Jun 8, 2022K213862HD60 Series Ultrasound Diagnostic System
Qingdao Hisense Medical Equipment Co., Ltd., CN
IYN
Jun 6, 2022K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
May 16, 2022K211665SONON Ultrasound Imaging System, Model: SONON300C
Healcerion Co., Ltd., KR
IYN
May 11, 2022K220446Versana Balance
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
May 6, 2022K220269HM70 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KP
IYN
Apr 29, 2022K220295ARIETTA 50
Fujifilm Healthcare Corporation, JP
IYN
Apr 22, 2022K212400SONON Ultrasound Imaging System, Model: SONON 500L
Healcerion Co., Ltd., KR
IYN
Apr 8, 2022K220490ImaCor Zura Handheld ZHH-010
Imacor, Inc.
IYN
Apr 5, 2022K220043HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System
Samsung Medison Co., Ltd., KR
IYN
Mar 25, 2022K220242TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Mar 22, 2022K214039LOGIQ P10, LOGIQ P9, LOGIQ P8
GE Medical Systems Ultrasound and Primary Care Diagnostics
IYN
Mar 22, 2022K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5
Canon Medical Systems Corporation, JP
IYN
Mar 4, 2022K220051TE Air Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
IYN
Mar 2, 2022K213279NovaGuide 2 Intelligent Ultrasound
Novasignal Corporation
IYN
Feb 18, 2022K211746Pocket Ultrasound System
Guangdong Youkey Medical Co., Ltd., CN
IYN
Feb 17, 2022K213689Voluson P6, Voluson P8
GE Healthcare
IYN
Feb 11, 2022K213487ACUSON P500 Ultrasound System
Siemens Medical Solutions USA, Inc.
IYN
Feb 11, 2022K211248ArtUs
Telemed, LT
IYN
Jan 28, 2022K213523X-CUBE i8, X-CUBE i9
Alpinion Medical Systems Co., Ltd., KR
IYN
Jan 24, 2022K212333Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
Canon Medical Systems Corporation, JP
IYN
Jan 13, 2022K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
GE Healthcare
IYN
Jan 11, 2022K213102ES1 System
E-Scopics, FR
IYN
Dec 27, 2021K213763Sonosite PX Ultrasound System
FUJIFILM Sonosite, Inc.
IYN
Dec 2, 2021K211886Clivia series Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technology Co. , Ltd., CN
IYN

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