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

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.3111
Volcano Corporation1917
CIVCO Medical Instruments Co., Inc.717
General Electric Co.210
Advanced Technology Laboratories, Inc.200
Hewlett-Packard Co.140
GE Medical Systems112
Ausonics Pty , Ltd.120
Hitachi Medical Corp. of America120
Toshiba Medical Systems120
Decided510(k)Device and applicantCode
Nov 17, 2017K170856CMS600P2 B-Ultrasound Diagnostic System
Contec Medical Systems Co.,Ltd, CN
IYO
Nov 14, 2017K173034FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
Echosens, FR
IYO
Oct 27, 2017K173138Biim Diagnostic Ultrasound System
Biim Ultrasound AS, NO
IYO
Oct 25, 2017K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
Volcano Corporation
IYO
Oct 20, 2017K171594Accuro
Rivanna Medical, LLC
IYO
Sep 29, 2017K171309BR-FHUS Navigation 1.0
Taihao Medical, Inc., TW
IYO
Sep 15, 2017K172356BladderScan Prime PLUS System
Verathon Incorporated
IYO
Sep 13, 2017K172142FibroScan 430 Mini+
Echosens, FR
IYO
Jul 31, 2017K171301Scanmate Flex
Dgh Technology, Inc.
IYO
Jul 18, 2017K171824Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYO
Jul 12, 2017K171766Acuson SC2000 Diagnostic Ultrasound System
Siemens Medi Cal Solutions, Inc.
IYO
Jun 22, 2017K171591CUBEScan™ BioCon-900 (Bladder Volume Measurement System)
Mcube Technology Co., Ltd., KR
IYO
Jun 12, 2017K161354MELODY, Remote Control System for Ultrasound Probe
Adecho Tech, FR
IYO
Jun 6, 2017K162372QT Ultrasound Breast Scanner-1
Qt Ultrasound, LLC
IYO
May 26, 2017K170133FFR V2.5
Philips Volcano
IYO
Apr 6, 2017K170385CORE M2 Vascular System
Volcano Corporation
IYO
Dec 2, 2016K162972ExactVu High Resolution Micro-Ultrasound System
Exact Imaging, CA
IYO
Nov 3, 2016K161968MicrUs
Telemed, LT
IYO
Jun 15, 2016K161342Sonic Window
Analogic Corporation
IYO
May 31, 2016K161300Acclarix AX8 Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYO
May 5, 2016K153620Enovare Ultrasound System
Oreon Technologies, Inc.
IYO
Apr 15, 2016K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
The Prometheus Group
IYO
Apr 8, 2016K153581Bladder Scanner
Caresono Technology Co., Ltd., TW
IYO
Mar 21, 2016K160420SpeqT
Signostics Limited, AU
IYO
Mar 18, 2016K160524FibroScan 530 Compact
Echosens, FR
IYO
Feb 2, 2016K153416ArcScan Insight 100
Arcscan, Inc.
IYO
Dec 22, 2015K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz
Volcano Corporation
IYO
Dec 14, 2015K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology
C.R. Bard, Inc.
IYO
Nov 25, 2015K1525734Sight
Accutome, Inc.
IYO
Nov 19, 2015K153101BladderScan Prime System
Verathon Incorporated
IYO
Nov 17, 2015K152318MD-2300S Ultrasonic A/B Scanner for Ophthalmology
MEDA Co., Ltd., CN
IYO
Sep 18, 2015K152316iLab Ultrasound Imaging System
Boston Scientific
IYO
Sep 10, 2015K151339SONON Ultrasound Imaging System (Model: SONON 300C)
Healcerion Co., Ltd., KR
IYO
Sep 1, 2015K150239FibroScan
Echosens, FR
IYO
Jul 17, 2015K151709Hi-Light Diagnostic Ultrasound Systems
Qingdao Hisense Medical Equipment Co., Ltd., CN
IYO
Jun 5, 2015K151060Ultrasound System SONIMAGE HS1
Konica Minolta, Inc., JP
IYO
Jun 3, 2015K150949FibroScan
Echosens, FR
IYO
May 8, 2015K150342Touch Ultrasound
Carestream Health, Inc.
IYO
May 6, 2015K150999Acclarix Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYO
Apr 7, 2015K150580UltraVision 2 Diagnostic Ultrasound System
Winprobe Corporation
IYO
Mar 30, 2015K150529Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System
C.R. Bard, Inc.
IYO
Mar 20, 2015K150441Volcano iFR Modality, iFR Scout feature
Volcano Corporation
IYO
Feb 20, 2015K143122Volcano iFR Harvest Software (Offline)
Volcano Corporation
IYO
Jan 23, 2015K143396omni TRAX Active Patient Tracker
Civco Medical Instruments CO Inc Dba Civco Medical Solutions
IYO
Jan 14, 2015K143493SignosRT Bladder Ultrasound System
Signostics, Ltd., AU
IYO
Dec 15, 2014K142329BBS REVOLUTION
Dbmedx, Inc.
IYO
Oct 31, 2014K142517SoftVue
Delphinus Medical Technologies, Inc.
IYO
Oct 30, 2014K142443Site-Rite 6 Ultrasound System with Pinpoint GT Technology
C.R. Bard, Inc.
IYO
Sep 29, 2014K142054IMACOR ZURA EVO IMAGING SYSTEM
Imacor, Inc.
IYO
Sep 19, 2014K141806CLEAR GUIDE ONE
Clear Guide Medical
IYO

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