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 28, 2010Siemens Medical Solutions USA, Inc.
ACUSON SC 2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit Ultrasound 1230 Shorebird Way Mountain View, CA 94043 Intended use: SC2000 ultrasound system is intended for the f
Terminated		 IYNK072365
Dec 28, 2010Siemens Medical Solutions USA, Inc.
4Z1c matrix array transducer which is used with ACUSON SC2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit Ultrasound 1230 Shorebird Way Mountain View, CA 94043 Intended use:
Terminated		 IYNK072365
Nov 26, 2010Sonosite, Inc.
The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system.
Terminated		 IYNK092058
Oct 1, 2010Sonosite, Inc.
SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer label is labeled in part: " MicroMaxx SLT...Manufactured for SonoSite, Inc., Bothell, WA 98021".
Terminated		 IYNK043559
Oct 1, 2010Sonosite, Inc.
Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part: "MicroMaxx LAP...Manufactured for SonoSite, Inc.,
Terminated		 IYNK043559
Aug 2, 2010Sonosite, Inc.
PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the
Terminated		 IYNK053069
K082098 +1
Mar 19, 2010Toshiba American Medical Systems Inc
Xario; SSA-660A; software version 1.0 and later
Terminated		 IYNK050380
Mar 19, 2010Toshiba American Medical Systems Inc
Aplio 80; SSA-770A; software version 5.5r002
Terminated		 IYNK041499
Mar 19, 2010Toshiba American Medical Systems Inc
Aplio 50; SSA-700A; software version 5.5r002
Terminated		 IYNK041499
Apr 7, 2009Cardinal Health, Inc
Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0470 Sonara Bilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for n
Terminated		 IYNK060421
Apr 7, 2009Cardinal Health, Inc
Viasys Healthcare, Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for
Terminated		 IYNK060421
Dec 31, 2008Philips Medical Systems
Philips Diagnostic Ultrasound System, Model HDI4000. Product labeled HDI4000 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Product also mark
Terminated		 IYNK031552
Dec 31, 2008Philips Medical Systems
Philips Diagnostic Ultrasound System, Model HD3. Product labeled HD3 Ultrasound System, Distributed by Philips Ultrasound, 22100 Bothell-Everett Highway, Bothell, WA 98021. Pulse Doppler Imaging Sys
Terminated		 IYNK031552
Oct 10, 2008Siemens Medical Solutions USA, Inc.
Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound
Terminated		 IYNK072676
Oct 8, 2008Siemens Medical Solutions USA, Inc.
Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software revision 1.0.06 and 1.0.07, Acuson X300 sofware revision 1.0.08 ultrasound system with onscreen
Terminated		 IYNK061946
Sep 29, 2008Siemens Medical Solutions USA, Inc.
Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system.
Terminated		 IYNK052894
Sep 19, 2008Siemens Medical Solutions USA, Inc.
Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with Software revisions less than 4.0.0b, material number 784539, 7848521, and 7848547. Is a general purpose, mobile, soft
Terminated		 IYNK032111
K042044 +2
Sep 17, 2008Boston Scientific Corporation
iReview" Software (Accessory To) iLab Ultrasound Imaging System, Model Number: H74900018010, Catalog Number: 1801; Product is manufactured and distributed by Boston Scientific Corporation, Fremont,
Terminated		 IYNK063493
Sep 16, 2008Philips Medical Systems
Biopsy Guide Starter Kits L9-5 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.
Terminated		 IYNK031552
Sep 16, 2008Philips Medical Systems
Biopsy Guide Starter Kits C7-3 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.
Terminated		 IYNK031552
Sep 16, 2008Philips Medical Systems
Biopsy Guide Starter Kits C5-2 used with the Philips HD3 Ultrasound System intended for diagnostic ultrasound imaging or fluid analysis of the human body.
Terminated		 IYNK031552
Sep 2, 2008Siemens Medical Solutions USA, Inc.
ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Real Time Imaging, UPG ACU,
Terminated		 IYNK063803
Jun 12, 2008GE Healthcare Clinical Systems
GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201
Terminated		 IYNK020263
Jun 10, 2008B & K Medical Systems, Inc.
B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887
Terminated		 IYNK024236
K043524
Apr 24, 2008Siemens Medical Solutions USA, Inc.
ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA
Terminated		 IYNK063085
Feb 15, 2008Siemens Medical Solutions USA, Inc.
Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Siemans, Mountain View, CA 94039
Terminated		 IYNK991805
Jan 9, 2008Toshiba American Med Sys Inc
Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780
Terminated		 IYNK063130
Jan 9, 2008Siemens Medical Solutions USA, Inc.
Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version 200.0.054, P/N 05936518 and 10037593 , Siemens, Ultrasound Division, Mountain View, CA 94039
Terminated		 IYNK063803
Jan 9, 2008Siemens Medical Solutions USA, Inc.
Siemens, ACUSON Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N : 10032747 and 10032746 standard, 10032746, 10037591, and 10038202 for prem
Terminated		 IYNK063803
Nov 17, 2007Toshiba American Med Sys Inc
NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0, Vl .5.000A, VI .5.000B, V2.0.0,Toshiba America Medical Systems, Inc., Tustin, CA.
Terminated		 IYNK061605
Jul 3, 2007Philips Medical Systems
HD11XE Diagnostic Ultrasound System
Terminated		 IYNK043535
Jun 27, 2007Toshiba American Med Sys Inc
Toshiba Aplio 50 Digital Ultrasound System, SSA-700A with version 6 software
Terminated		 IYNK022400
Jun 27, 2007Toshiba American Med Sys Inc
Toshiba Aplio 80 Digital Ultrasound System, SSA-770A with version 6 software
Terminated		 IYNK041499
Mar 29, 2007Sonosite, Inc.
MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
Terminated		 IYNK043559
K053069
Feb 17, 2007Philips Ultrasound, Inc.
iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic)
Terminated		 IYNK030455
Jun 27, 2006General Electric Med. Sys. Ultrasound
Voluson 730 Expert, Voluson 730 Pro, Voluson 730 ProV with software versions 4.0.0, 4.0.1, 4.0.2, 4.0.3, 4.0.4, 4.0.5, 5.00, 5.0.1. The device is a general-purpose diagnostic ultrasound system.
Terminated		 IYNK041688
May 9, 2006B & K Medical Systems, Inc.
Convex Array Transducer used with B-K Ultrasound Scanners Model number: 8667
Terminated		 IYNNone listed
Jan 11, 2006General Electric Med Systems LLC
LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
Terminated		 IYNK014206
Jan 11, 2006General Electric Med Systems LLC
LOGIQ 5 system models 2331752, 2331753, 2332750, 2353313 and 2355477.
Terminated		 IYNK014097
Aug 25, 2005Biosound Esaote, Inc.
MyLab25 Ultrasound Imaging System; Model 9807300002.
Terminated		 IYNK040596
Aug 25, 2005Biosound Esaote, Inc.
MyLab30CV Ultrasound Imaging System; model 9807300001.
Terminated		 IYNK040596
Aug 25, 2005Biosound Esaote, Inc.
MyLab30CV Ultrasound Imaging System; model 9807300000.
Terminated		 IYNK040596
Jul 13, 2005Toshiba American Med Sys Inc
Aplio Diagnostic Ultrasound System (SSA-700A and SSA-770A) with software version 6.0er001 and 6.0er002
Terminated		 IYNNone listed
Jun 22, 2005Philips Ultrasound, Inc.
Envisor, M2540 Diagnostic Ultrasound System
Terminated		 IYNK014191
Dec 2, 2004B & K Medical Systems Inc.
Linear Array Transducer Type: 8809
Terminated		 IYNK000567
K024236 +1
Nov 5, 2004Philips Ultrasound, Inc.
HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
Terminated		 IYNK002185
Jul 20, 2004DWL Systems, Inc.
EZ-DOP, diagnostic ultrasound imaging system
Terminated		 IYNNone listed
Jul 20, 2004Spencer Technologies, Inc.
Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the
Terminated		 IYNK002533
Jul 20, 2004Siemans Medial Solutions USA, Inc
Acuson Cypress Echocardiography System
Terminated		 IYNK021497
Jul 2, 2003Siemans Medial Solutions USA, Inc
Acuson Cypress Echocardiography System. Imaging System
Terminated		 IYNK021497

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