ClearanceBrief
Panels › Radiology › Product code IYO · Class 2

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)
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Top companies in IYO

DateFirm and productCodeLinked 510(k)
Jul 6, 2012Civco 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
IYOK092619
Jul 6, 2012Civco 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
IYOK092619
Jul 6, 2012Civco 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
IYOK092619
Jul 6, 2012Civco 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
IYOK092619
May 30, 2012Siemens 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
IYOK111674
May 30, 2012Siemens 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
IYOK111674
Feb 7, 2012Volcano 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
IYONone listed
Aug 10, 2011Toshiba 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
IYOK091295
May 6, 2011Siemens 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
IYOK072676
Apr 25, 2011Siemens 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
IYOK072676
Apr 4, 2011Siemens 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
IYOK082142
Mar 28, 2011Siemens 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
IYOK082142
Mar 3, 2011Toshiba American Medical Systems Inc
SSH-880CV Aplio Artida; System, Diagnostic Ultrasound
Terminated
IYOK090158
Feb 1, 2011Siemens 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
IYOK063803
K082142
Nov 1, 2010Volcano 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
IYOK082229
Oct 4, 2010Verathon, 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
IYOK090214
Oct 4, 2010Verathon, 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
IYOK082456
Oct 4, 2010Verathon, 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
IYOK082456
Aug 9, 2010Sonosite, 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
IYOK071134
Jul 6, 2010Toshiba American Medical Systems Inc
SSH-880CV Aplio Artida System
Terminated
IYOK090158
Mar 11, 2010Toshiba American Medical Systems Inc
PET-511BTM Multi-plane transesophageal transducer (TEE) used with Toshiba Diagnostic Ultrasound System
Terminated
IYOK072918
Dec 16, 2009GE Medical Systems, LLC
GE Healthcare Voluson E6, GE Voluson E8, and GE Voluson E8 Expert Diagnostic Ultrasound Systems
Terminated
IYOK061682
Nov 9, 2009GE 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
IYOK023178
K033244 +4
Sep 17, 2009Verathon, 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
IYOK071217
Dec 16, 2008Boston 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
IYONone listed
Sep 23, 2008Boston Scientific Corporation
iLab Ultrasound Imaging System, Models 120INS and 240INS, manufactured by Boston Scientific Corporation, Fremont, CA 94538
Terminated
IYOK072517
Sep 22, 2008GE 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
IYOK061682
Sep 11, 2008Siemens 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
IYOK063085
Sep 2, 2008Siemens 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
IYOK063803
Dec 28, 2007Ellex 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
IYOK041947
Nov 17, 2007Toshiba 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
IYOK043078
Nov 7, 2007Ge 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
IYOK061682
Aug 23, 2007Volcano 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
IYOK051920

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