ClearanceBrief
Panels › Radiology › Product code IYO · Class 2

System, Imaging, Pulsed Echo, Ultrasonic

Regulation 892.1560

9510(k)s in 12 months (896 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)
Sep 25, 2026Volcano Corp
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Open, Classified
IYOK253714
Apr 1, 2026Civco Medical Instruments Co. Inc.
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Open, Classified
IYOK092619
Apr 1, 2026Civco Medical Instruments Co. Inc.
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
Open, Classified
IYOK092619
Apr 1, 2026Civco Medical Instruments Co. Inc.
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
Open, Classified
IYOK092619
Apr 1, 2026Civco Medical Instruments Co. Inc.
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
Open, Classified
IYOK092619
Apr 1, 2026Civco Medical Instruments Co. Inc.
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
Open, Classified
IYOK092619
Apr 1, 2026Civco Medical Instruments Co. Inc.
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Open, Classified
IYOK092619
Apr 1, 2026Civco Medical Instruments Co. Inc.
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
Open, Classified
IYOK092619
Apr 1, 2026Civco Medical Instruments Co. Inc.
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
Open, Classified
IYOK092619
Jan 24, 2022Volcano Corp
IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102
Open, Classified
IYOK203719
Jan 24, 2022GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
Terminated
IYOK161588
K180995
Jan 24, 2022GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
Terminated
IYOK161588
K180995
Jan 24, 2022GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
Terminated
IYOK161588
K180995
Jan 24, 2022GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
Terminated
IYOK161588
K180995
Jan 24, 2022GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Terminated
IYOK161588
K180995
Jan 24, 2022GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
Terminated
IYOK161588
K180995
Jan 24, 2022GE Healthcare, LLC
GE Vscan Extend, being sold as "Vscan Extend Console"
Terminated
IYOK161588
K180995
Oct 8, 2021Civco Medical Instruments Co. Inc.
VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
Terminated
IYOK092619
Oct 8, 2021Civco Medical Instruments Co. Inc.
VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
Terminated
IYOK092619
Oct 8, 2021Civco Medical Instruments Co. Inc.
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
Terminated
IYOK092619
Oct 8, 2021Civco Medical Instruments Co. Inc.
VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
Terminated
IYOK092619
Aug 6, 2021Philips Ultrasound Inc
Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 7951
Completed
IYOK182857
Aug 6, 2021Philips Ultrasound Inc
EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -7952
Completed
IYOK182857
Dec 12, 2019Volcano Corporation
Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s
Terminated
IYOK170133
Nov 4, 2019Becton Dickinson & Company
Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human body. Site~Rite 8 Ultrasound System, Catalog No.9770500 Refurbished, Site~Rite 8 System, Catalog No.9770500R Site
Terminated
IYOK152554
May 17, 2018Volcano Corporation
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the periphera
Terminated
IYOK172455
Mar 22, 2018GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
GE LOGIQ E9 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
IYOK082185
K092271 +3
Nov 22, 2017ECOLAB INC
ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier
Terminated
IYOK961029
Nov 22, 2017ECOLAB INC
ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrie
Terminated
IYOK961029
Apr 13, 2017Parker Laboratories, Inc.
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Terminated
IYOK802146
Nov 30, 2015Verathon, Inc.
BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.
Terminated
IYOK082456
Jul 20, 2015Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and COR
Terminated
IYOK123898
Jul 20, 2015Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i an
Terminated
IYOK123898
Jul 20, 2015Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE
Terminated
IYOK123898
Jul 20, 2015Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology: The Volcano s5/s5i
Terminated
IYOK123898
Jul 20, 2015Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE
Terminated
IYOK123898
Jul 20, 2015Volcano Corporation
Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and C
Terminated
IYOK123898
Jul 8, 2015Volcano Corp
ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular struct
Terminated
IYOK082229
Jul 8, 2015Volcano Corp
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravascular Imaging and Pr
Terminated
IYOK123898
Jul 8, 2015Volcano Corp
Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Ima
Terminated
IYOK123898
May 5, 2015Siemens Medical Solutions USA, Inc.
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applicat
Terminated
IYOK123622
Feb 7, 2015Siemens Medical Solutions USA, Inc.
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for i
Terminated
IYOK081148
Dec 16, 2014Soma Access Systems LLC
AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultra
Terminated
IYOK113680
Oct 29, 2014Parker Laboratories, Inc.
Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasou
Terminated
IYOK953673
Nov 21, 2013GE Healthcare, LLC
GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiol
Terminated
IYOK120201
Oct 18, 2013SonoSite, Inc.
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with So
Terminated
IYOK113156
K130173
Sep 16, 2013Sonogage Inc
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Terminated
IYONone listed
Mar 9, 2013Siemens Medical Solutions USA, Inc.
ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (AB
Terminated
IYOK081148
Sep 10, 2012Volcano Corporation
Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and dist
Terminated
IYOK082229
K111706
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

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