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)
Top companies in IYO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Volcano Corp Philips IntraSight Plus
REF: 797423 and 797417
100-120v-220-240v,50/60hZ, 1000 VA Open, Classified |
IYO | K253714 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 Open, Classified |
IYO | K092619 |
| Jan 24, 2022 | Volcano Corp IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102 Open, Classified |
IYO | K203719 |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi" Terminated |
IYO | K161588 K180995 |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Sector USB" Terminated |
IYO | K161588 K180995 |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Sector DICOM" Terminated |
IYO | K161588 K180995 |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi" Terminated |
IYO | K161588 K180995 |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Dual USB" Terminated |
IYO | K161588 K180995 |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" Terminated |
IYO | K161588 K180995 |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Console" Terminated |
IYO | K161588 K180995 |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX Terminated |
IYO | K092619 |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, Sensor with 10 17 GA
VirtutTRAX Terminated |
IYO | K092619 |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX Terminated |
IYO | K092619 |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX Terminated |
IYO | K092619 |
| Aug 6, 2021 | Philips 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 |
IYO | K182857 |
| Aug 6, 2021 | Philips 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 |
IYO | K182857 |
| Dec 12, 2019 | Volcano 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 |
IYO | K170133 |
| Nov 4, 2019 | Becton 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 |
IYO | K152554 |
| May 17, 2018 | Volcano 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 |
IYO | K172455 |
| Mar 22, 2018 | GE 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 |
IYO | K082185 K092271 +3 |
| Nov 22, 2017 | ECOLAB 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 |
IYO | K961029 |
| Nov 22, 2017 | ECOLAB 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 |
IYO | K961029 |
| Apr 13, 2017 | Parker Laboratories, Inc. Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case Terminated |
IYO | K802146 |
| Nov 30, 2015 | Verathon, 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 |
IYO | K082456 |
| Jul 20, 2015 | Volcano 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 |
IYO | K123898 |
| Jul 20, 2015 | Volcano 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 |
IYO | K123898 |
| Jul 20, 2015 | Volcano 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 |
IYO | K123898 |
| Jul 20, 2015 | Volcano 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 |
IYO | K123898 |
| Jul 20, 2015 | Volcano 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 |
IYO | K123898 |
| Jul 20, 2015 | Volcano 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 |
IYO | K123898 |
| Jul 8, 2015 | Volcano 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 |
IYO | K082229 |
| Jul 8, 2015 | Volcano 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 |
IYO | K123898 |
| Jul 8, 2015 | Volcano 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 |
IYO | K123898 |
| May 5, 2015 | Siemens 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 |
IYO | K123622 |
| Feb 7, 2015 | Siemens 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 |
IYO | K081148 |
| Dec 16, 2014 | Soma 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 |
IYO | K113680 |
| Oct 29, 2014 | Parker 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 |
IYO | K953673 |
| Nov 21, 2013 | GE 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 |
IYO | K120201 |
| Oct 18, 2013 | SonoSite, 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 |
IYO | K113156 K130173 |
| Sep 16, 2013 | Sonogage Inc Sonogage EyeScan, A-Scan Biometer,
Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length. Terminated |
IYO | None listed |
| Mar 9, 2013 | Siemens 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 |
IYO | K081148 |
| Sep 10, 2012 | Volcano 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 |
IYO | K082229 K111706 |
| 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 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.