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
Jul 23, 2021K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)
Fcu Co., Ltd., KR
IYO
Jul 8, 2021K203659iSR'obot Mona Lisa 1.0
Biobot Surgical Pte., Ltd., SG
IYO
Jun 25, 2021K211193BD Prevue II Peripheral Vascular Vascular Access System
Bard Access Systems, Inc. (C.R. Bard, Inc.)
IYO
Jun 24, 2021K211623THD Procto Software System
Thd Spa, IT
IYO
Jun 9, 2021K210591Palm Bladder Scanner - PBSV7.1
Mianyang Meike Electronic Equipment Co., Ltd., CN
IYO
May 26, 2021K211098Breast Volume Navigator (BVN) Model G-2000
Metritrack, Inc.
IYO
Mar 25, 2021K203273FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)
Echosens, FR
IYO
Feb 26, 2021K201316Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)
Suzhou Peaksonic Medical Technology Co., Ltd., CN
IYO
Jan 19, 2021K203719IntraSight Mobile
Volcano Corporation
IYO
Oct 7, 2020K202119AcuSee AS-P1000 System
Weipeng (Suzhou) Medical Devices Co., Ltd., CN
IYO
Aug 19, 2020K201995CUBEScan BioCon-1100
Mcube Technology Co., Ltd., KR
IYO
Jul 31, 2020K201597Liver Incytes, Model 1005
Sonic Incytes, CA
IYO
Jul 16, 2020K200655FibroScan® 630
Echosens, FR
IYO
Jun 11, 2020K200980Auto 3D Bladder Volume Tool
Butterfly Network, Inc.
IYO
May 19, 2020K200749CUBEScan BioCon-900S
Mcube Technology Co., Ltd., KR
IYO
Mar 27, 2020K200548CUBEScan BioCon-1100
Mcube Technology Co., Ltd., KR
IYO
Mar 17, 2020K200136Shear Wave Quantificational Ultrasound Diagnostic System
Wuxi Hisky Medical Technologies Co., Ltd., CN
IYO
Feb 25, 2020K192253SonicEye Dual-Array Ultrasound System
Sonivate Medical, Inc.
IYO
Jan 26, 2020K193512THD Procto Software System
Thd Spa, IT
IYO
Jan 23, 2020K192170VistaScan USB Ultrasound Imaging System
Emagine Solutions Technology, LLC
IYO
Nov 27, 2019K192791Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYO
Nov 19, 2019K192573Dolphin Medical Imaging USB Ultrasound System
Dolphin Medical Imaging, LLC
IYO
Oct 18, 2019K190646QT Scanner 2000 Model A
Qt Ultrasound, LLC
IYO
Oct 9, 2019K190314Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000
Mednovel Technology, Ltd.
IYO
Jul 10, 2019K191541Vave Personal Ultrasound System
Vave Health, Inc.
IYO
Jul 1, 2019K183173LIGHTMED Ultrasound System
Lightmed USA, Inc.
IYO
Jun 5, 2019K191307Palm Bladder Scanner - PBSV5.1
Mianyang Meike Electronic Equipment Co., Ltd., CN
IYO
May 22, 2019K190769Bladder Scanner (Models: M2, M2-W, M1, M1-W)
Suzhou Lischka Medtech Co., Ltd., CN
IYO
May 6, 2019K182460MD-6000P Bladder Scanner
MEDA Co., Ltd., CN
IYO
Apr 11, 2019K190786Eye Prime
Ellex Medical Pty, Ltd., AU
IYO
Mar 28, 2019K190186Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System
Edan Instruments, Inc., CN
IYO
Mar 20, 2019K183414ABSOLU
Quantel Medical, FR
IYO
Mar 8, 2019K190039EchoSure Diagnostic Ultrasound System
Sonavex, Inc.
IYO
Oct 24, 2018K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
C. R. Bard
IYO
Sep 14, 2018K182213QT Ultrasound Breast Scanner - 1
Qt Ultrasound, LLC
IYO
Sep 6, 2018K182153Ultrasound System SONIMAGE HS1
Konica Minolta, Inc., JP
IYO
Jul 10, 2018K181574Uscan
EchoNous, Inc.
IYO
Jul 9, 2018K181547FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
Echosens, FR
IYO
Jun 22, 2018K173595Shear Wave Quantificational Ultrasound Diagnostic System
Wuxi Hisky Medical Technologies Co., Ltd., CN
IYO
Apr 30, 2018K180636ExactVu High Resolution Micro-Ultrasound System
Exact Imaging, Inc., CA
IYO
Apr 13, 2018K170761LIGHTSonic BUBM
Lightmed USA, Inc.
IYO
Apr 11, 2018K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, COR
Volcano Corporation
IYO
Mar 2, 2018K180265COMPACT TOUCH Ophthalmic Ultrasound System
Quantel Medical, FR
IYO
Mar 2, 2018K172256SoftVue
Delphinus Medical Technologies
IYO
Feb 28, 2018K172750Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)
Guangzhou Sonostar Technologies Co., Ltd., CN
IYO
Feb 8, 2018K180084Ultrasound System SONIMAGE MX1
Konica Minolta, Inc., JP
IYO
Jan 24, 2018K171528Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
Avantsonic Technology Co., Ltd., CN
IYO
Dec 13, 2017K172056InnoSight Diagnostic Ultrasound System
Qisda Corporation, TW
IYO
Dec 7, 2017K170046Lilium a-200E
Lilium Otsuka Co., Ltd., JP
IYO
Dec 1, 2017K172931DUS-6000 Digital Ultrasonic Diagnostic Imaging System
Advanced Instrumentations, Inc.
IYO

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