ClearanceBrief
Panels › Radiology › Product code IYO · Class 2

System, Imaging, Pulsed Echo, Ultrasonic

Regulation 892.1560

10510(k)s in 12 months (897 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
Oct 20, 2026K262093Accuro XV
Rivanna Medical, Inc.
IYO
Oct 16, 2026K260605Lilium one (USM330)
Lilium Otsuka Co., Ltd., JP
IYO
Sep 24, 2026K260313MD-6000S Bladder Scanner
MEDA Co., Ltd., CN
IYO
Jul 24, 2026K253452Accuro 3S
Rivanna Medical, Inc.
IYO
Jun 18, 2026K260190ARTHUR
ROPCA ApS, DK
IYO
Apr 17, 2026K252237EdgeFlow UW20
Edgecare, Inc., KR
IYO
Apr 9, 2026K254021Accuro XV
Rivanna Medical, Inc.
IYO
Mar 4, 2026K253898QT Scanner 2000 Model A
QT Imaging Holdings, Inc.
IYO
Feb 24, 2026K253714IntraSight Plus
Philips Image Guided Therapy Corporation
IYO
Feb 6, 2026K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
Eieling Technology (Shenzhen) Limited, CN
IYO
Sep 30, 2025K250331Astrasono A3Pro Bladder Scanner (A3Pro)
Astrasono Technology Co., Ltd., CN
IYO
Aug 1, 2025K250381Deepsight NeedleVue LC1 Ultrasound System
DeepSight Technology, Inc.
IYO
Jul 11, 2025K243227B-Scan
Accutome, Inc. Doing Business AS Keeler USA
IYO
Jun 26, 2025K251728Velacur One (LI-1100)
Sonic Incytes Medical Corp, CA
IYO
Jun 17, 2025K243880Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300,
Wuxi Hisky Medical Technologies Co., Ltd., CN
IYO
May 23, 2025K243937Accuro 3S
Rivanna Medical, Inc.
IYO
Apr 23, 2025K243479EchoGuide (Version 1)
Sonavex, Inc.
IYO
Nov 19, 2024K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
Eieling Technology (Shenzhen) Limited, CN
IYO
Oct 7, 2024K241029SpineUs™ System
Verdure Imaging
IYO
Sep 4, 2024K233977Velacur
Sonic Incytes, CA
IYO
Jun 26, 2024K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)
Fcu Co., Ltd., KR
IYO
Jun 12, 2024K233613ACUSON SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYO
May 3, 2024K232895B-Ultrasound Diagnostic System
Contec Medical Systems Co.,Ltd, CN
IYO
Apr 26, 2024K232302Pocket III
Quantel Medical, FR
IYO
Mar 6, 2024K231677EdgeFlow UH10
Edgecare, Inc., KR
IYO
Feb 18, 2024K240146BD Prevue™ II Peripheral Vascular Access System
Bard Access Systems, Inc.
IYO
Feb 12, 2024K233401Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
Eieling Technology Limited, CN
IYO
Dec 29, 2023K230986Bladder Scanner
Avantsonic Technology Co., Ltd., CN
IYO
Dec 21, 2023K232320iSR`obot Mona Lisa 2.0
Biobot Surgical Pte., Ltd., SG
IYO
Dec 21, 2023K231889Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
Ultrasound Biotechnology (Shanghai) Co., Ltd., CN
IYO
Oct 25, 2023K230511K3900 Ultrasound Imaging System
Maui Imaging
IYO
Sep 12, 2023K232459Velacur
Sonic Incytes, CA
IYO
Sep 11, 2023K231283SiteRite™ 9 Ultrasound System
Bard Access Systems, Inc. (C.R. Bard, Inc.)
IYO
Jul 7, 2023K223448Bladder Scanner Model: BVT02
Xuzhou Kaixin Electronic Instrument Co., Ltd., CN
IYO
Apr 20, 2023K223287Velacur
Sonic Incytes, CA
IYO
Mar 31, 2023K220068Butterfly iQ/iQ+ Ultrasound System
Butterfly Network, Inc.
IYO
Mar 2, 2023K223902FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)
Echosens, FR
IYO
Jan 9, 2023K222787Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P
Chongqing Sunkingdom Medical Instrument Co., Ltd., CN
IYO
Aug 31, 2022K220933QT Scanner 2000 Model A
Qt Imaging, Inc.
IYO
Jul 1, 2022K213488Bladder Scanner, Model Name:M5
Suzhou Peaksonic Medical Technology Co., Ltd., CN
IYO
May 5, 2022K211529NAVIRFA Scope
Navifus Corporation, TW
IYO
Apr 22, 2022K213620ATUSA™ Automated 3D Breast Ultrasound System
Isono Health, Inc.
IYO
Mar 16, 2022K212851EchoSK and EchoSGyn modules for EchoS Family devices
Echolight S.P.A, IT
IYO
Dec 22, 2021K213411iSR’obot Mona Lisa 2.0
Biobot Surgical Pte., Ltd., SG
IYO
Dec 7, 2021K213303Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 0
Infraredx, Inc.
IYO
Nov 18, 2021K213070MD-320W Ultrasound Biomicroscope
MEDA Co., Ltd., CN
IYO
Nov 15, 2021K213254Axialis Ophthalmic Ultrasound System
Quantel Medical, FR
IYO
Nov 5, 2021K211726Acuson SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
IYO
Jul 30, 2021K212035FibroScan 230
Echosens, FR
IYO
Jul 23, 2021K210468SC1 Handheld Ultrasound Imaging System (Model: SC1)
Fcu Co., Ltd., KR
IYO

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