System, Imaging, Pulsed Echo, Ultrasonic
Regulation 892.1560
11510(k)s in 12 months (898 all time)
9recalls in 12 months (83 all time)
80recalls that name a 510(k)
Top companies in IYO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2012 | Civco Medical Instruments Inc CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. Terminated |
IYO | K092619 |
| Jul 6, 2012 | Civco Medical Instruments Inc CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. The firm na Terminated |
IYO | K092619 |
| Jul 6, 2012 | Civco Medical Instruments Inc CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name Terminated |
IYO | K092619 |
| Jul 6, 2012 | Civco Medical Instruments Inc CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telesco Terminated |
IYO | K092619 |
| May 30, 2012 | Siemens Medical Solutions USA, Inc. Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial
compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A);
Model #: 10440017 - ACUSON S2000 Terminated |
IYO | K111674 |
| May 30, 2012 | Siemens Medical Solutions USA, Inc. Siemens brand ACUSON S2000 Ultrasound Systems, and the Advanced SieClearTM spatial
compounding feature Software Versions 3.0, 3.0A and 3.1. (VB20, VB20A, and VB21A); Model #: 10041461 - ACUSON S2000 M Terminated |
IYO | K111674 |
| Feb 7, 2012 | Volcano Corporation Volcano pcFM Software Kit ;
Manufactured by: Volcano Corporation, 2870 Kilgore Road, Rancho Cardova, CA 95624.
The volcano pcFM Software Kit is a research only off line tool intended for review and p Terminated |
IYO | None listed |
| Aug 10, 2011 | Toshiba American Medical Systems Inc Aplio XG model SSA-790A
Aplio XG (SSA-790A) is a premium-class diagnostic ultrasound system incorporating state-of-the-art technologies. It is provided with the highest level of image quality and op Terminated |
IYO | K091295 |
| May 6, 2011 | Siemens Medical Solutions USA, Inc. Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 10348532 and 10348533, manufactured by Siemens Medical Solutions, Mountain View, CA.
Intended for General Terminated |
IYO | K072676 |
| Apr 25, 2011 | Siemens Medical Solutions USA, Inc. Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01 (model numbers 10348531, 10348532 and 10348533), when using the V5Ms transducer (model number 08263703) and the Plu Terminated |
IYO | K072676 |
| Apr 4, 2011 | Siemens Medical Solutions USA, Inc. TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or VA15B; Model Numbers: 10041461 (Acuson S2000) and 8263703 (V5M Transducer);
Product is manufac Terminated |
IYO | K082142 |
| Mar 28, 2011 | Siemens Medical Solutions USA, Inc., Mountain View, CA ACUSON S2000 ultrasound systems (all versions) with cardiovascular options installed;
ACUSON S2000: 10041461;
S2000 Cardio Option: 10041853;
Product is manufactured and distributed by
Siemens Medic Terminated |
IYO | K082142 |
| Mar 3, 2011 | Toshiba American Medical Systems Inc SSH-880CV Aplio Artida; System, Diagnostic Ultrasound Terminated |
IYO | K090158 |
| Feb 1, 2011 | Siemens Medical Solutions USA, Inc. 10041461 ACUSON S2000, manufactured by Siemens Medical Solutions, Mountain View, CA.
Intended for Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/Gyn, Cardiac, Pelvic, Neon Terminated |
IYO | K063803 K082142 |
| Nov 1, 2010 | Volcano Corporation Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology, manufactured by Volcano Corporation of Rancho Cordova, CA. Terminated |
IYO | K082229 |
| Oct 4, 2010 | Verathon, Inc. BladderScan BVM 9500
The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasi Terminated |
IYO | K090214 |
| Oct 4, 2010 | Verathon, Inc. AortaScan AMI 9700
The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements Terminated |
IYO | K082456 |
| Oct 4, 2010 | Verathon, Inc. BVI 9600 Bladder Volume Instrument, Aorta Scan Mode
The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the l Terminated |
IYO | K082456 |
| Aug 9, 2010 | Sonosite, Inc. SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021".
The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (P Terminated |
IYO | K071134 |
| Jul 6, 2010 | Toshiba American Medical Systems Inc SSH-880CV Aplio Artida System Terminated |
IYO | K090158 |
| Mar 11, 2010 | Toshiba American Medical Systems Inc PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic Ultrasound System Terminated |
IYO | K072918 |
| Dec 16, 2009 | GE Medical Systems, LLC GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems Terminated |
IYO | K061682 |
| Nov 9, 2009 | GE Medical Systems, LLC GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Terminated |
IYO | K023178 K033244 +4 |
| Sep 17, 2009 | Verathon, Inc. The BladderScan BVI 9400 is a portable ultrasound instrument that provides a noninvasive measurement of urinary bladder volume. The device consists of an ultrasound probe that scans the patient's bla Terminated |
IYO | K071217 |
| Dec 16, 2008 | Boston Scientific Corporation Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS. Its intended use is for ultrasound examination of intravascular pathology. Manufactured by Boston Scientific Corporation, Terminated |
IYO | None listed |
| Sep 23, 2008 | Boston Scientific Corporation iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538 Terminated |
IYO | K072517 |
| Sep 22, 2008 | GE Healthcare GE Voluson E8 Ultrasound System with software versions 6.0.0, 6.0.1,6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01.
Intended for use by a qualified physician for ultrasound evaluation of Fetal?O Terminated |
IYO | K061682 |
| Sep 11, 2008 | Siemens Medical Solutions USA, Inc. Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound System;
Model Number(s): 10035724, used with System Models: 08245875, 08246951, 08255412, 08255413, 08267697, 08269627, Terminated |
IYO | K063085 |
| Sep 2, 2008 | Siemens Medical Solutions USA, Inc. Sonoline 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 Imaging, Field Upgrade, PN Terminated |
IYO | K063803 |
| Dec 28, 2007 | Ellex Inc. Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Ellex Innovative Imaging, Sacramento, CA 95827 Terminated |
IYO | K041947 |
| Nov 17, 2007 | Toshiba American Med Sys Inc NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B, V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0, V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Toshi Terminated |
IYO | K043078 |
| Nov 7, 2007 | Ge Healthcare GE Healthcare Voluson E8 ultrasound scanner with Software version 6.2.0 and 6.2.1 and DICOM stations with these software versions; GE Healthcare 9900 West Innovation Drive, Wauwatosa, WI 53226, USA. Terminated |
IYO | K061682 |
| Aug 23, 2007 | Volcano Corporation Volcano s5 Imaging system, Ultrasound pulsed echo imaging system. Product consists of the CPU, control console, monitor, printer, and patient interface module (PIM) Terminated |
IYO | K051920 |
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