System, Imaging, Pulsed Echo, Ultrasonic

FDA product code IYO · 862 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1560
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-08-03 – 2026-09-24

IYO 2026-09-24

MD-6000S Bladder Scanner

Applicant MEDA Co., Ltd.

K number K260313

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IYO 2026-07-24

Accuro 3S

Applicant Rivanna Medical, Inc.

K number K253452

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IYO 2026-06-18

ARTHUR

Applicant ROPCA ApS

K number K260190

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IYO 2026-04-17

EdgeFlow UW20

Applicant Edgecare, Inc.

K number K252237

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IYO 2026-04-09

Accuro XV

Applicant Rivanna Medical, Inc.

K number K254021

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IYO 2026-03-04

QT Scanner 2000 Model A

Applicant QT Imaging Holdings, Inc.

K number K253898

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IYO 2026-02-24

IntraSight Plus

Applicant Philips Image Guided Therapy Corporation

K number K253714

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IYO 2026-02-06

Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)

Applicant Eieling Technology (Shenzhen) Limited

K number K253221

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IYO 2025-09-30

Astrasono A3Pro Bladder Scanner (A3Pro)

Applicant Astrasono Technology Co., Ltd.

K number K250331

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IYO 2025-08-01

Deepsight NeedleVue LC1 Ultrasound System

Applicant DeepSight Technology, Inc.

K number K250381

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IYO 2025-07-11

B-Scan

Applicant Accutome, Inc. Doing Business AS Keeler USA

K number K243227

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IYO 2025-06-26

Velacur One (LI-1100)

Applicant Sonic Incytes Medical Corp

K number K251728

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IYO 2025-06-17

Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)

Applicant Wuxi Hisky Medical Technologies Co., Ltd.

K number K243880

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IYO 2025-05-23

Accuro 3S

Applicant Rivanna Medical, Inc.

K number K243937

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IYO 2025-04-23

EchoGuide (Version 1)

Applicant Sonavex, Inc.

K number K243479

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IYO 2024-11-19

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)

Applicant Eieling Technology (Shenzhen) Limited

K number K242496

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IYO 2024-10-07

SpineUs™ System

Applicant Verdure Imaging

K number K241029

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IYO 2024-09-04

Velacur

Applicant Sonic Incytes

K number K233977

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IYO 2024-06-26

SC1 Handheld Ultrasound Imaging system (Model: SC1)

Applicant Fcu Co., Ltd.

K number K233579

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IYO 2024-06-12

ACUSON SC2000 Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K number K233613

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IYO 2024-05-03

B-Ultrasound Diagnostic System

Applicant Contec Medical Systems Co.,Ltd

K number K232895

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IYO 2024-04-26

Pocket III

Applicant Quantel Medical

K number K232302

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IYO 2024-03-06

EdgeFlow UH10

Applicant Edgecare, Inc.

K number K231677

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IYO 2024-02-18

BD Prevue™ II Peripheral Vascular Access System

Applicant Bard Access Systems, Inc.

K number K240146

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IYO 2024-02-12

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)

Applicant Eieling Technology Limited

K number K233401

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IYO 2023-12-29

Bladder Scanner

Applicant Avantsonic Technology Co., Ltd.

K number K230986

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IYO 2023-12-21

iSR`obot Mona Lisa 2.0

Applicant Biobot Surgical Pte., Ltd.

K number K232320

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IYO 2023-12-21

Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)

Applicant Ultrasound Biotechnology (Shanghai) Co., Ltd.

K number K231889

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IYO 2023-10-25

K3900 Ultrasound Imaging System

Applicant Maui Imaging

K number K230511

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IYO 2023-09-12

Velacur

Applicant Sonic Incytes

K number K232459

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IYO 2023-09-11

SiteRite™ 9 Ultrasound System

Applicant Bard Access Systems, Inc. (C.R. Bard, Inc.)

K number K231283

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IYO 2023-07-07

Bladder Scanner Model: BVT02

Applicant Xuzhou Kaixin Electronic Instrument Co., Ltd.

K number K223448

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IYO 2023-04-20

Velacur

Applicant Sonic Incytes

K number K223287

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IYO 2023-03-31

Butterfly iQ/iQ+ Ultrasound System

Applicant Butterfly Network, Inc.

K number K220068

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IYO 2023-03-02

FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)

Applicant Echosens

K number K223902

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IYO 2023-01-09

Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P

Applicant Chongqing Sunkingdom Medical Instrument Co., Ltd.

K number K222787

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IYO 2022-08-31

QT Scanner 2000 Model A

Applicant Qt Imaging, Inc.

K number K220933

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IYO 2022-07-01

Bladder Scanner, Model Name:M5

Applicant Suzhou Peaksonic Medical Technology Co., Ltd.

K number K213488

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IYO 2022-05-05

NAVIRFA Scope

Applicant Navifus Corporation

K number K211529

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IYO 2022-04-22

ATUSA™ Automated 3D Breast Ultrasound System

Applicant Isono Health, Inc.

K number K213620

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IYO 2022-03-16

EchoSK and EchoSGyn modules for EchoS Family devices

Applicant Echolight S.P.A

K number K212851

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IYO 2021-12-22

iSR’obot Mona Lisa 2.0

Applicant Biobot Surgical Pte., Ltd.

K number K213411

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IYO 2021-12-07

Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42

Applicant Infraredx, Inc.

K number K213303

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IYO 2021-11-18

MD-320W Ultrasound Biomicroscope

Applicant MEDA Co., Ltd.

K number K213070

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IYO 2021-11-15

Axialis Ophthalmic Ultrasound System

Applicant Quantel Medical

K number K213254

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IYO 2021-11-05

Acuson SC2000 Diagnostic Ultrasound System

Applicant Siemens Medical Solutions USA, Inc.

K number K211726

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IYO 2021-07-30

FibroScan 230

Applicant Echosens

K number K212035

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IYO 2021-07-23

SC1 Handheld Ultrasound Imaging System (Model: SC1)

Applicant Fcu Co., Ltd.

K number K210468

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IYO 2021-07-08

iSR'obot Mona Lisa 1.0

Applicant Biobot Surgical Pte., Ltd.

K number K203659

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IYO 2021-06-25

BD Prevue II Peripheral Vascular Vascular Access System

Applicant Bard Access Systems, Inc. (C.R. Bard, Inc.)

K number K211193

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IYO 2021-06-24

THD Procto Software System

Applicant Thd Spa

K number K211623

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IYO 2021-06-09

Palm Bladder Scanner - PBSV7.1

Applicant Mianyang Meike Electronic Equipment Co., Ltd.

K number K210591

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IYO 2021-05-26

Breast Volume Navigator (BVN) Model G-2000

Applicant Metritrack, Inc.

K number K211098

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IYO 2021-03-25

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)

Applicant Echosens

K number K203273

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IYO 2021-02-26

Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)

Applicant Suzhou Peaksonic Medical Technology Co., Ltd.

K number K201316

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IYO 2021-01-19

IntraSight Mobile

Applicant Volcano Corporation

K number K203719

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IYO 2020-10-07

AcuSee AS-P1000 System

Applicant Weipeng (Suzhou) Medical Devices Co., Ltd.

K number K202119

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IYO 2020-08-19

CUBEScan BioCon-1100

Applicant Mcube Technology Co., Ltd.

K number K201995

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IYO 2020-07-31

Liver Incytes, Model 1005

Applicant Sonic Incytes

K number K201597

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IYO 2020-07-16

FibroScan® 630

Applicant Echosens

K number K200655

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IYO 2020-06-11

Auto 3D Bladder Volume Tool

Applicant Butterfly Network, Inc.

K number K200980

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IYO 2020-05-19

CUBEScan BioCon-900S

Applicant Mcube Technology Co., Ltd.

K number K200749

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IYO 2020-03-27

CUBEScan BioCon-1100

Applicant Mcube Technology Co., Ltd.

K number K200548

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IYO 2020-03-17

Shear Wave Quantificational Ultrasound Diagnostic System

Applicant Wuxi Hisky Medical Technologies Co., Ltd.

K number K200136

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IYO 2020-02-25

SonicEye Dual-Array Ultrasound System

Applicant Sonivate Medical, Inc.

K number K192253

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IYO 2020-01-26

THD Procto Software System

Applicant Thd Spa

K number K193512

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IYO 2020-01-23

VistaScan USB Ultrasound Imaging System

Applicant Emagine Solutions Technology, LLC

K number K192170

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IYO 2019-11-27

Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K number K192791

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IYO 2019-11-19

Dolphin Medical Imaging USB Ultrasound System

Applicant Dolphin Medical Imaging, LLC

K number K192573

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IYO 2019-10-18

QT Scanner 2000 Model A

Applicant Qt Ultrasound, LLC

K number K190646

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IYO 2019-10-09

Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000

Applicant Mednovel Technology, Ltd.

K number K190314

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IYO 2019-07-10

Vave Personal Ultrasound System

Applicant Vave Health, Inc.

K number K191541

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IYO 2019-07-01

LIGHTMED Ultrasound System

Applicant Lightmed USA, Inc.

K number K183173

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IYO 2019-06-05

Palm Bladder Scanner - PBSV5.1

Applicant Mianyang Meike Electronic Equipment Co., Ltd.

K number K191307

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IYO 2019-05-22

Bladder Scanner (Models: M2, M2-W, M1, M1-W)

Applicant Suzhou Lischka Medtech Co., Ltd.

K number K190769

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IYO 2019-05-06

MD-6000P Bladder Scanner

Applicant MEDA Co., Ltd.

K number K182460

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IYO 2019-04-11

Eye Prime

Applicant Ellex Medical Pty, Ltd.

K number K190786

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IYO 2019-03-28

Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K number K190186

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IYO 2019-03-20

ABSOLU

Applicant Quantel Medical

K number K183414

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IYO 2019-03-08

EchoSure Diagnostic Ultrasound System

Applicant Sonavex, Inc.

K number K190039

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IYO 2018-10-24

Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech

Applicant C. R. Bard

K number K182281

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IYO 2018-09-14

QT Ultrasound Breast Scanner - 1

Applicant Qt Ultrasound, LLC

K number K182213

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IYO 2018-09-06

Ultrasound System SONIMAGE HS1

Applicant Konica Minolta, Inc.

K number K182153

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IYO 2018-07-10

Uscan

Applicant EchoNous, Inc.

K number K181574

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IYO 2018-07-09

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)

Applicant Echosens

K number K181547

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IYO 2018-06-22

Shear Wave Quantificational Ultrasound Diagnostic System

Applicant Wuxi Hisky Medical Technologies Co., Ltd.

K number K173595

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IYO 2018-04-30

ExactVu High Resolution Micro-Ultrasound System

Applicant Exact Imaging, Inc.

K number K180636

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IYO 2018-04-13

LIGHTSonic BUBM

Applicant Lightmed USA, Inc.

K number K170761

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IYO 2018-04-11

s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System

Applicant Volcano Corporation

K number K173860

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IYO 2018-03-02

COMPACT TOUCH Ophthalmic Ultrasound System

Applicant Quantel Medical

K number K180265

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IYO 2018-03-02

SoftVue

Applicant Delphinus Medical Technologies

K number K172256

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IYO 2018-02-28

Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)

Applicant Guangzhou Sonostar Technologies Co., Ltd.

K number K172750

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IYO 2018-02-08

Ultrasound System SONIMAGE MX1

Applicant Konica Minolta, Inc.

K number K180084

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IYO 2018-01-24

Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)

Applicant Avantsonic Technology Co., Ltd.

K number K171528

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IYO 2017-12-13

InnoSight Diagnostic Ultrasound System

Applicant Qisda Corporation

K number K172056

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IYO 2017-12-07

Lilium a-200E

Applicant Lilium Otsuka Co., Ltd.

K number K170046

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IYO 2017-12-01

DUS-6000 Digital Ultrasonic Diagnostic Imaging System

Applicant Advanced Instrumentations, Inc.

K number K172931

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IYO 2017-11-17

CMS600P2 B-Ultrasound Diagnostic System

Applicant Contec Medical Systems Co.,Ltd

K number K170856

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IYO 2017-11-14

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)

Applicant Echosens

K number K173034

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IYO 2017-10-27

Biim Diagnostic Ultrasound System

Applicant Biim Ultrasound AS

K number K173138

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