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)
Dec 17, 2018Olympus Corporation of the Americas
Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Terminated		 IYNK093395
Sep 14, 2018GE Healthcare, LLC
GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, tes
Terminated		 IYNK173555
Jun 11, 2018ESAOTE S.P.A.
MyLab Seven, Model 6400
Terminated		 IYNK142008
K142077 +1
Jun 11, 2018ESAOTE S.P.A.
MyLab Gamma, Model 7410
Terminated		 IYNK142008
K142077 +1
Jun 11, 2018ESAOTE S.P.A.
MyLab Alpha, Model 7400
Terminated		 IYNK142008
K142077 +1
Mar 26, 2018Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Terminated		 IYNK170315
Mar 22, 2018GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified
Terminated		 IYNNone listed
Mar 22, 2018GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified p
Terminated		 IYNK060542
Mar 22, 2018GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast,
Terminated		 IYNK150087
K170823 +1
Mar 22, 2018GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or unde
Terminated		 IYNK150087
K170823 +1
Mar 22, 2018GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction
Terminated		 IYNK150087
K170823 +1
Mar 22, 2018GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qua
Terminated		 IYNK131514
Mar 22, 2018GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); N
Terminated		 IYNK061129
Jan 26, 2018Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult
Terminated		 IYNK162221
Jan 4, 2018Toshiba American Medical Systems Inc
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the
Terminated		 IYNK163702
Jan 3, 2018ESAOTE S.P.A.
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33
Terminated		 IYNK081386
K163082
Jan 3, 2018ESAOTE S.P.A.
MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
Terminated		 IYNK081386
K163082
Dec 4, 2017Konica Minolta Medical Imaging USA, Inc.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
Terminated		 IYNK151060
Dec 4, 2017Konica Minolta Medical Imaging USA, Inc.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 04560141945470
Terminated		 IYNK162065
Dec 4, 2017Konica Minolta Medical Imaging USA, Inc.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8WA, UDI: 04560141944534
Terminated		 IYNK152577
Dec 4, 2017Konica Minolta Medical Imaging USA, Inc.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031
Terminated		 IYNK142197
May 2, 2017Hitachi Medical Systems America Inc
Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
Terminated		 IYNK134016
May 1, 2017Toshiba American Medical Systems Inc
APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
Terminated		 IYNK161843
May 1, 2017Toshiba American Medical Systems Inc
APLIO 500 TUS-A500 diagnostic ultrasound system
Terminated		 IYNK151451
May 1, 2017Toshiba American Medical Systems Inc
APLIO 300 TUS-A300 diagnostic ultrasound system
Terminated		 IYNK151451
May 1, 2017Toshiba American Medical Systems Inc
XARIO 200 TUS-X200 diagnostic ultrasound system
Terminated		 IYNK162155
May 1, 2017Toshiba American Medical Systems Inc
XARIO 100 TUS-X100 diagnostic ultrasound system
Terminated		 IYNK162187
Apr 24, 2017Konica Minolta, Inc.
Diagnostics Ultrasound System Ultrasounds System Sonimage HS1
Terminated		 IYNK142197
K152577 +1
Mar 30, 2017Siemens Medical Solutions USA, Inc.
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refur
Terminated		 IYNK163635
Mar 10, 2017GE Healthcare, LLC
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Terminated		 IYNK150087
Mar 10, 2017GE Healthcare, LLC
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Terminated		 IYNK150087
Jan 19, 2017Carestream Health Inc
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
Terminated		 IYNK152467
Nov 28, 2016Siemens Medical Solutions USA, Inc.
Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Card
Terminated		 IYNK123622
Aug 4, 2016Toshiba American Medical Systems Inc
Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200.
Terminated		 IYNK143027
K143046
Jul 18, 2016Carestream Health Inc
Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 --- Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the hu
Terminated		 IYNK152467
Jun 28, 2016B-K Medical A/S
BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the
Terminated		 IYNK140428
K143298 +2
Apr 8, 2016Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
Terminated		 IYNK123622
Mar 28, 2016Philips Ultrasound, Inc.
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fet
Terminated		 IYNK132304
Jan 6, 2016Philips Ultrasound, Inc.
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
Terminated		 IYNK152899
Oct 30, 2015Siemens Medical Solutions USA, Inc.
ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.
Terminated		 IYNK123622
Sep 17, 2015Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-na
Terminated		 IYNK123622
Sep 5, 2015Siemens Medical Solutions USA, Inc.
ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound S
Terminated		 IYNK123001
Aug 5, 2015Siemens Medical Solutions USA, Inc.
ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008 6C1HD Needle Guide, S3000; 10440586 6C1 HD Biopsy Guide, S2000 18L6 - model nu
Terminated		 IYNK142876
Jul 30, 2015Siemens Medical Solutions USA, Inc.
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology:
Terminated		 IYNK132804
Jul 29, 2015Siemens Medical Solutions USA, Inc.
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 sy
Terminated		 IYNK132804
Jul 2, 2015Siemens Medical Solutions USA, Inc.
ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following a
Terminated		 IYNNone listed
May 19, 2015Philips Ultrasound, Inc.
EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 45356172
Terminated		 IYNK132304
May 19, 2015Philips Ultrasound, Inc.
EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 4535617367
Terminated		 IYNK132304
May 6, 2015Siemens Medical Solutions USA, Inc.
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and F
Terminated		 IYNK123622
May 5, 2015Philips Ultrasound, Inc.
EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 4
Terminated		 IYNK132304

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