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)
Top companies in IYN
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2015 | Philips Ultrasound, Inc. EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205. Part Number: 989605408541 With
453561736761 (1.1)
453561750041 (1.1.1)
45 Terminated |
IYN | K132304 |
| Feb 5, 2015 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2.
The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Ped Terminated |
IYN | K123622 |
| Dec 16, 2014 | Philips Ultrasound, Inc. EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Terminated |
IYN | K132304 |
| Dec 16, 2014 | Philips Ultrasound, Inc. EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Terminated |
IYN | K132304 |
| Jul 1, 2014 | Siemens Medical Solutions USA, Inc. ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems. Terminated |
IYN | K132804 |
| Jun 11, 2014 | Hitachi Aloka Medical, Ltd. Prosound F75 or F75
The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intr Terminated |
IYN | K123828 |
| May 28, 2014 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature. Ultrasound imaging system. Terminated |
IYN | K123622 |
| May 28, 2014 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasound imaging system. Terminated |
IYN | K123622 |
| Apr 24, 2014 | Siemens Medical Solutions USA, Inc. Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system. Terminated |
IYN | K123001 |
| Apr 23, 2014 | GE Healthcare, LLC GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging. Terminated |
IYN | K131514 |
| Apr 22, 2014 | Boston Scientific Corporation iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology. Terminated |
IYN | None listed |
| Apr 3, 2014 | Siemens Medical Solutions USA, Inc. Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348).
Provides imaging for guidance of biopsy and imaging to assist in the placement of n Terminated |
IYN | K121384 |
| Mar 20, 2014 | Philips Medical Systems North America Inc. Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206
EPIQ is intended fo Terminated |
IYN | K132304 |
| Mar 20, 2014 | Philips Medical Systems North America Inc. Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis.
Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206
EPIQ is intended fo Terminated |
IYN | K132304 |
| Jan 24, 2014 | Siemens Medical Solutions USA, Inc. ACUSON SC2000
Power Input: 100-240VAC, 1600 Max 50/60Hz;
Siemens Medical Solutions USA, Inc.
685 East Middlefield Road
Mountain View, CA 94043
Ultrasound imaging system. Terminated |
IYN | K123622 |
| Jan 24, 2014 | Siemens Medical Solutions USA, Inc. ACUSON SC2000 Ultrasound System;
Power Input: 100-240VAC, 1600W Max, 50/60 Hz.
Manufacturer:
Siemens Medical Solutions USA, Inc.
685 East Middlefield Road
Mountain View, CA 94043
SC2000 ultrasound i Terminated |
IYN | K123622 |
| Nov 20, 2013 | Philips Medical Systems North America Inc. EPIQ 7 Ultrasound System, Model 795200, 795201, 795202.
Intended for diagnostic ultrasound imaging and fluid flow analysis. Terminated |
IYN | K132304 |
| Oct 30, 2013 | Toshiba American Medical Systems Inc Aplio XG Diagnostic Ultrasound System SSA-790A
Used for routine diagnostic imaging Terminated |
IYN | K091295 |
| Oct 30, 2013 | Toshiba American Medical Systems Inc Aplio MX Diagnostic Ultrasound System SSA-780A
Used for routine diagnostic imaging Terminated |
IYN | K092948 |
| Oct 30, 2013 | Toshiba American Medical Systems Inc Xario XG Diagnostic Ultrasound System SSA-680A
Used for routine diagnostic imaging Terminated |
IYN | K072918 |
| Oct 30, 2013 | Toshiba American Medical Systems Inc Xario Diagnostic Ultrasound System SSA-660A
Used for routine diagnostic imaging Terminated |
IYN | K050380 |
| Oct 23, 2013 | Siemens Medical Solutions USA, Inc. Acuson SC2000 volume imaging ultrasound systems at software version 3.0.
Mfg name:
Siemens Medical Solutions USA, Inc.
Mountain View, CA 94043
Medical Device for human use. Ultrasound imaging system Terminated |
IYN | K123622 |
| Aug 9, 2013 | GE Healthcare, LLC GE Healthcare, LOGIQ S8 Ultrasound System
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neo Terminated |
IYN | K111582 |
| Aug 1, 2013 | GE Healthcare, LLC GE Healthcare, LOGIQ e Ultrasound System.
The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flo Terminated |
IYN | K113690 |
| Jul 31, 2013 | GE Healthcare, LLC GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM.
The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fe Terminated |
IYN | K112213 |
| Apr 11, 2013 | GE Healthcare, LLC GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The Terminated |
IYN | K111582 K122114 |
| Apr 10, 2013 | Siemens Medical Solutions USA, Inc. Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200;
The SC2000 ultrasound imaging system is intended for the following applicati Terminated |
IYN | K123622 |
| May 16, 2012 | Siemens Medical Solutions USA, Inc. ACUSON S1000 ultrasound systems running software version 1.0, Siemens Medical Solutions, USA, Inc. Mountain View, CA. The product is indicated for use as an ultrasound imaging system. Terminated |
IYN | K111674 |
| Feb 23, 2012 | GE Healthcare, LLC GE Healthcare, LOGIQ S8 DIAGNOSTIC ULTRASOUND SYSTEM with R1.1.0 Software.
Intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ; Peripheral Terminated |
IYN | K111582 |
| Jan 21, 2012 | GE Healthcare, LLC GE LOGIQ P6 Ultrasound System.
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; S Terminated |
IYN | K073297 |
| Jan 11, 2012 | GE Healthcare, LLC GE LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1.
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric Terminated |
IYN | K110943 |
| Oct 18, 2011 | Sonosite, Inc. MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound.
General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound im Terminated |
IYN | K043559 K053069 +2 |
| Jul 29, 2011 | Toshiba American Medical Systems Inc Aplio Artida Ultrasound Diagnostic System SSH-880CV.
Toshiba American Medical Systems, Inc.
A diagnostic ultrasound system. Terminated |
IYN | K090158 |
| Jul 11, 2011 | Bard Access Systems Site Rite Vision Ultrasound System, REF 9770032,
Bard Access Systems, Inc.
Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Terminated |
IYN | K100402 |
| Jun 8, 2011 | Hitachi Medical Systems America Inc Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10).
The Preirus and Terminated |
IYN | K093466 K102901 |
| May 19, 2011 | Toshiba American Medical Systems Inc Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound Terminated |
IYN | K090158 |
| May 10, 2011 | Toshiba American Medical Systems Inc Toshiba America Medical Systems Inc. SSH-880CV Aplio Artida; Diagnostic Ultrasound System Terminated |
IYN | K090158 |
| May 6, 2011 | Siemens Medical Solutions USA, Inc. Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems;
Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162, 250163, 250164, 250166, 250167 and 250169); Terminated |
IYN | K081148 |
| Apr 29, 2011 | Siemens Medical Solutions USA, Inc. ACUSON Antares 5.0 Base System, model number 10042832. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA.
The ACUSON Antares is a general purpose Diagnos Terminated |
IYN | None listed |
| Apr 29, 2011 | Siemens Medical Solutions USA, Inc. ACUSON Sequoia 12.X GI Base System, model number 10042701. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA.
The ACUSON Sequoia is a general purpose Dia Terminated |
IYN | None listed |
| Apr 29, 2011 | Siemens Medical Solutions USA, Inc. ACUSON Sequoia 12.X C512/512 SS Base System, model number 10042700. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA.
The ACUSON Sequoia is a general pu Terminated |
IYN | None listed |
| Apr 29, 2011 | Siemens Medical Solutions USA, Inc. ACUSON Sequoia C512/512SS Adv PE 10.0 System, model number 10041127. Distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA.
The ACUSON Sequoia is a general p Terminated |
IYN | None listed |
| Apr 25, 2011 | Philips Medical Systems Nederlands S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471.
The User information is labeled in part: "***iE33 Ultrasound System ***User Information Update***4535 614 04811 Re Terminated |
IYN | K030455 |
| Apr 25, 2011 | Siemens Medical Solutions USA, Inc. Acuson X300 systems at software versions 1.00.00 to 1.0.10 and 2.0.00 to 2.0.02, model numbers 10037409, 10132987, and 10038837, manufactured by Siemens Medical Solutions ultrasound business unit, Mou Terminated |
IYN | K072676 |
| Apr 22, 2011 | Siemens Medical Solutions USA, Inc. ACUSON S2000 ultrasound system
Manufactured by Siemens Medical Solutions USA, Inc.
Business Unit Ultrasound,
1230 Shorebird Way
Intended for the following applications: Fetal, abdominal, Intraoperati Terminated |
IYN | K082142 |
| Apr 8, 2011 | Siemens Medical Solutions USA, Inc. 8V3c transducer used with the ACUSON SC2000 ultrasound system. 8V3c transducer model number 10433823; ACUSON SC2000 model number 10433816.
Siemens Medical Solutions USA, Inc.
Business Unit Ultrasoun Terminated |
IYN | K102017 |
| Mar 30, 2011 | Siemens Medical Solutions USA, Inc. Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0. Terminated |
IYN | K023720 K033196 +2 |
| Mar 28, 2011 | Siemens Medical Solutions USA, Inc., Mountain View, CA ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and 5.0 with cardiovascular options installed;
ACUSON Antares 4.0 & 5.0: 10032747, 10037592, 10040728;
ACUSON Ant Terminated |
IYN | K063803 |
| Mar 28, 2011 | Siemens Medical Solutions USA, Inc. Acuson S2000 Ultrasound System with software and imaging.
The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, tra Terminated |
IYN | K093812 |
| Feb 1, 2011 | Siemens Medical Solutions USA, Inc. 10032746 Acuson Antares PE Product Version 5.0, manufactured by Siemens Medical Solutions, Mountain View, CA.
Intended for Abdominal, Intraoperative, Small Parts, Transcranial, OB/Gyn, Cardiac, Trans Terminated |
IYN | K063803 K082142 |
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