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)
4recalls 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
DateFirm and productCodeLinked 510(k)
Nov 9, 2023Philips Ultrasound, Inc.
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Completed		 IYNK231190
Nov 9, 2023Philips Ultrasound, Inc.
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 79
Completed		 IYNK231190
Sep 29, 2023GE MEDICAL SYSTEMS, ISRAEL LTD.
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
Open, Classified		 IYNK183362
K202233 +1
Sep 13, 2023Siemens Medical Solutions USA, Inc.
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Open, Classified		 IYNK210743
Jul 10, 2023GE Vingmed Ultrasound As
GE Healthcare Vivid S70N, ultrasound device
Open, Classified		 IYNK170878
K182450 +4
Jul 10, 2023GE Vingmed Ultrasound As
GE Healthcare Vivid S60N, ultrasound device
Open, Classified		 IYNK170878
K182450 +4
Jul 10, 2023GE Vingmed Ultrasound As
GE Healthcare Vivid S70, ultrasound device
Open, Classified		 IYNK142323
Jul 10, 2023GE Vingmed Ultrasound As
GE Healthcare Vivid S60, ultrasound device
Open, Classified		 IYNK142323
Feb 1, 2023NovaSignal Corp.
NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)
Open, Classified		 IYNK160442
K180455
Feb 1, 2023NovaSignal Corp.
Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
Open, Classified		 IYNK160442
Dec 22, 2022GE Medical Systems, LLC
Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult
Open, Classified		 IYNNone listed
Dec 22, 2022GE Medical Systems, LLC
Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult
Open, Classified		 IYNNone listed
Dec 22, 2022GE Medical Systems, LLC
Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult
Open, Classified		 IYNK071985
K092079 +2
Dec 22, 2022GE Medical Systems, LLC
Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult
Open, Classified		 IYNK071985
K092079 +2
Nov 8, 2022Canon Medical System, USA, INC.
Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450
Open, Classified		 IYNK212333
K212960
Apr 27, 2022Siemens Medical Solutions USA, Inc.
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Open, Classified		 IYNK211859
Jan 19, 2022Siemens Medical Solutions USA, Inc.
Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdominal, Neonatal, Echo
Open, Classified		 IYNK201130
Nov 12, 2021Siemens Medical Solutions USA, Inc.
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Open, Classified		 IYNK201462
Oct 14, 2021FujiFilm Healthcare Americas Corporation
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Open, Classified		 IYNK181376
Oct 14, 2021FujiFilm Healthcare Americas Corporation
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Open, Classified		 IYNK162583
Oct 14, 2021FujiFilm Healthcare Americas Corporation
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Open, Classified		 IYNK171708
K173739 +1
Oct 14, 2021FujiFilm Healthcare Americas Corporation
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Open, Classified		 IYNK191233
Sep 21, 2021Philips Ultrasound Inc
EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Terminated		 IYNK200304
Aug 19, 2021Philips Ultrasound Inc
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795116, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Terminated		 IYNK201012
Aug 19, 2021Philips Ultrasound Inc
Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Terminated		 IYNK201012
Jul 22, 2021Philips Ultrasound Inc
EPIQ Ultrasound Systems, Model: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx, EPIQ CVxi
Completed		 IYNK182857
Jul 12, 2021Siemens Medical Solutions USA, Inc.
ACUSON Juniper Diagnostic Ultrasound System
Terminated		 IYNK201130
Jun 30, 2021Hitachi Healthcare Americas Corporation
Model L43K Intraoperative Probe-For the diagnostic ultrasound evaluation during robotic/non-robotic intra-operative and laparoscopic procedures
Open, Classified		 IYNK173739
K183456
Mar 1, 2021Hitachi Medical Systems America Inc
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operativ
Terminated		 IYNK183456
Feb 4, 2021Siemens Medical Solutions USA, Inc.
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
Open, Classified		 IYNK193257
Dec 24, 2020Philips Ultrasound Inc
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and
Terminated		 IYNK182857
Dec 16, 2020Philips Ultrasound Inc
Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz,
Terminated		 IYNK182857
Oct 27, 2020Philips Ultrasound Inc
All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - E
Terminated		 IYNK182857
Oct 16, 2020Olympus Corporation of the Americas
Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light so
Terminated		 IYNK093395
Sep 8, 2020ESAOTE S.P.A
AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM180PS19-XE1057, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is in
Terminated		 IYNK161359
Sep 8, 2020ESAOTE S.P.A
AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM180PS19-XE0338, AC/DC Adapter associated with the following portable ultrasound diagnostic systems: The AC/DC adapter is in
Terminated		 IYNK161359
Mar 17, 2020Butterfly Network, Inc.
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usa
Terminated		 IYNK163510
Mar 17, 2020Butterfly Network, Inc.
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Pro
Terminated		 IYNK163510
Feb 5, 2020Mindray DS USA, Inc. dba Mindray North America
DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patient
Terminated		 IYNK183660
Aug 6, 2019Philips Ultrasound Inc
Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage
Terminated		 IYNK182857
Jul 25, 2019NeuroLogica Corporation
WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00
Terminated		 IYNK153529
K173513
Jul 25, 2019NeuroLogica Corporation
HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.12
Terminated		 IYNK173713
Jul 12, 2019GE Healthcare, LLC
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
Terminated		 IYNK180374
K180535 +1
Jul 12, 2019GE Healthcare, LLC
Refurbish RIC5-9-D Probe ROHS compliant Ultrasound Probe RIC5-9-D
Terminated		 IYNK152309
K160182 +3
May 21, 2019GE Healthcare, LLC
LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan
Open, Classified		 IYNK161588
Jan 30, 2019GE Healthcare, LLC
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal
Terminated		 IYNK073297
Jan 28, 2019Siemens Medical Solutions USA, Inc.
ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI #
Open, Classified		 IYNK152469
K173957
Jan 28, 2019Siemens Medical Solutions USA, Inc.
ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056
Open, Classified		 IYNK152469
K173957
Jan 28, 2019Siemens Medical Solutions USA, Inc.
ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagn
Open, Classified		 IYNK172374
K173981
Jan 28, 2019Siemens Medical Solutions USA, Inc.
ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic
Open, Classified		 IYNK161787
K172374 +1

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