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 2017-10-25

CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit

Applicant Volcano Corporation

K number K172455

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IYO 2017-10-20

Accuro

Applicant Rivanna Medical, LLC

K number K171594

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IYO 2017-09-29

BR-FHUS Navigation 1.0

Applicant Taihao Medical, Inc.

K number K171309

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IYO 2017-09-15

BladderScan Prime PLUS System

Applicant Verathon Incorporated

K number K172356

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IYO 2017-09-13

FibroScan 430 Mini+

Applicant Echosens

K number K172142

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IYO 2017-07-31

Scanmate Flex

Applicant Dgh Technology, Inc.

K number K171301

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IYO 2017-07-18

Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K number K171824

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IYO 2017-07-12

Acuson SC2000 Diagnostic Ultrasound System

Applicant Siemens Medi Cal Solutions, Inc.

K number K171766

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IYO 2017-06-22

CUBEScan™ BioCon-900 (Bladder Volume Measurement System)

Applicant Mcube Technology Co., Ltd.

K number K171591

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IYO 2017-06-12

MELODY, Remote Control System for Ultrasound Probe

Applicant Adecho Tech

K number K161354

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IYO 2017-06-06

QT Ultrasound Breast Scanner-1

Applicant Qt Ultrasound, LLC

K number K162372

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IYO 2017-05-26

FFR V2.5

Applicant Philips Volcano

K number K170133

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IYO 2017-04-06

CORE M2 Vascular System

Applicant Volcano Corporation

K number K170385

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IYO 2016-12-02

ExactVu High Resolution Micro-Ultrasound System

Applicant Exact Imaging

K number K162972

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IYO 2016-11-03

MicrUs

Applicant Telemed

K number K161968

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IYO 2016-06-15

Sonic Window

Applicant Analogic Corporation

K number K161342

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IYO 2016-05-31

Acclarix AX8 Diagnostic Ultrasound System

Applicant Edan Instruments, Inc.

K number K161300

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IYO 2016-05-05

Enovare Ultrasound System

Applicant Oreon Technologies, Inc.

K number K153620

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IYO 2016-04-15

Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound

Applicant The Prometheus Group

K number K160792

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IYO 2016-04-08

Bladder Scanner

Applicant Caresono Technology Co., Ltd.

K number K153581

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IYO 2016-03-21

SpeqT

Applicant Signostics Limited

K number K160420

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IYO 2016-03-18

FibroScan 530 Compact

Applicant Echosens

K number K160524

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IYO 2016-02-02

ArcScan Insight 100

Applicant Arcscan, Inc.

K number K153416

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IYO 2013-12-20

CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE

Applicant Volcano Corporation

K number K133641

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IYO 2013-12-19

SOFTVUE

Applicant Delphinus Medical Technologies, Inc.

K number K123209

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IYO 2013-11-15

VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION

Applicant Volcano Corporation

K number K133142

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IYO 2013-09-26

ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc. Ultrasound Gro

K number K132654

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IYO 2013-09-17

DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

Applicant Edan Instruments, Inc.

K number K131830

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IYO 2013-08-20

UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Samsung Medison Co., Ltd.

K number K132228

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IYO 2013-07-24

M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K131690

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IYO 2013-07-12

PADSCAN HD SERIES BLADDER SCANNER

Applicant Carenoso Technology Co., Ltd.

K number K131227

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IYO 2013-06-25

TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION

Applicant Tractus Corporation

K number K131489

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IYO 2013-06-07

ISR'OBOT MONA LISA

Applicant Biobot Surgical Pte., Ltd.

K number K130944

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IYO 2013-05-03

ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER

Applicant MEDA Co., Ltd.

K number K121243

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IYO 2013-04-05

FIBROSCAN

Applicant Echosens

K number K123806

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IYO 2013-03-20

PALM BLADDER SCANNER

Applicant Mianyang Meike Electronic Equipment Co., Ltd.

K number K130229

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IYO 2013-03-01

ILAB ULTRASOUND IMAGING SYSTEM

Applicant Boston Scientific Corp

K number K130243

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IYO 2013-01-29

A-SCAN PLUS CONNECT

Applicant Accutome, Inc.

K number K123349

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IYO 2013-01-15

ILAB ULTRASOUND IMAGING SYSTEM

Applicant Boston Scientific Corp

K number K123535

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IYO 2013-01-14

VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM

Applicant Volcano Corporation

K number K123898

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IYO 2012-12-21

PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM

Applicant Sonoscape Company Limited

K number K123616

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IYO 2012-11-02

DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K123185

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IYO 2012-10-12

DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6

Applicant Edan Instruments, Inc.

K number K122574

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IYO 2012-09-19

VITASCAN LT SCANMASTER

Applicant Vitacon Medical, Inc.

K number K121689

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IYO 2012-09-13

AIM

Applicant Inneroptic Technology, Inc.

K number K121479

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IYO 2012-08-16

APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Toshiba Medical Systems Coporation, Japan

K number K121422

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IYO 2012-07-26

E-CUBE 15

Applicant Alpinion Medical Systems Co., Ltd.

K number K121888

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IYO 2012-06-13

SONIXGPS NEEDLE SENSOR

Applicant Ultrasonix Medical Corporation

K number K111818

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IYO 2012-06-07

VIEWFLEX XTRA ICE CATHETER

Applicant St Jude Medical

K number K121381

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IYO 2012-05-30

SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE

Applicant Bard Access Systems, Inc.

K number K120882

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IYO 2012-04-19

GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

Applicant Ge Vingmed Ultrasound AS

K number K120201

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IYO 2012-03-23

BLADDER SCANNER

Applicant MEDA Co., Ltd.

K number K113304

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IYO 2012-01-30

CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE

Applicant Leiker Regulatory & Quality Consulting

K number K112539

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IYO 2012-01-27

VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM

Applicant Volcano Corporation

K number K113486

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IYO 2012-01-25

DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

Applicant Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

K number K113632

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IYO 2011-12-29

SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT

Applicant Soma Access Systems, LLC

K number K113680

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IYO 2011-11-28

DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K113153

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IYO 2011-11-15

SONOSITE EDGE ULTRASOUND SYSTEM

Applicant Sonosite,Inc.

K number K113156

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IYO 2011-09-22

DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

Applicant Advanced Instrumentations, Inc.

K number K112022

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IYO 2011-08-12

ISROBOT MONA LISA

Applicant Biobot Surgical Pte., Ltd.

K number K111347

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IYO 2011-07-15

VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM

Applicant Volcano Corporation

K number K111706

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IYO 2011-07-08

DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K111435

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IYO 2011-06-02

MYLABGOLD

Applicant Esaote

K number K110688

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IYO 2011-03-14

ECHO BLASTER

Applicant Telemed

K number K102253

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IYO 2011-03-11

AIDA DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Panasonic Healthcare Co., Ltd.

K number K103148

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IYO 2011-01-20

MOBIUS ULTRASOUND IMAGING SYSTEM

Applicant Mobisante, Inc.

K number K102153

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IYO 2010-12-27

I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND

Applicant Ellex, Inc.

K number K103608

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IYO 2010-12-22

AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM

Applicant Quantel Medical S.A.

K number K102027

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IYO 2010-11-05

VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM

Applicant Ge Medical System Israel , Ltd.

K number K102393

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IYO 2010-11-05

COMPACT TOUCH STS

Applicant Quantel Medical S.A.

K number K102198

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IYO 2010-10-22

M5 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K102991

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IYO 2010-10-13

GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

Applicant Ge Vingmed Ultrasound AS

K number K101149

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IYO 2010-09-30

A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM

Applicant Sonoscape Company Limited

K number K101337

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IYO 2010-09-15

ECO SUPERGEL

Applicant Ceracarta Spa

K number K101429

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IYO 2010-06-17

HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS

Applicant Hitachi Medical Systems America, Inc.

K number K093466

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IYO 2010-05-21

ULTRA DCI MODEL 5000

Applicant Ultrasound Medical Devices, Inc.

K number K100363

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IYO 2010-04-22

COMPACT TOUCH

Applicant Quantel S.A.

K number K094038

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IYO 2010-04-09

MASTER-VU A-SCAN, MV4500

Applicant Sonomed, Inc.

K number K100252

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IYO 2010-04-05

MODEL DGH 6000 SCANMATE A

Applicant Dgh Technology, Inc.

K number K093371

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IYO 2010-03-16

VESISCAN

Applicant Life-Tech, Inc.

K number K093485

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IYO 2010-03-01

DIGITAL ULTRASOUND SCANNER

Applicant Shenzhen Well.D Medical Electronics Co., Ltd.

K number K100079

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IYO 2009-12-23

OTI-SCAN 3000

Applicant Opko Instrumentation, Inc.

K number K092837

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IYO 2009-11-20

ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Aloka Co., Ltd.

K number K093488

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IYO 2009-11-13

ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER

Applicant Civco

K number K092619

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IYO 2009-10-09

VOYAGER COMPACT IMAGING SYSTEM

Applicant Ardent Sound, Inc.

K number K092182

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IYO 2009-09-18

CFI ULTRASOUND PROBE DRAPE

Applicant Contour Fabricators, Inc.

K number K090773

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IYO 2009-08-21

GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND

Applicant Ge Medical Systems Israel, Ultrasound, Ltd.

K number K092140

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IYO 2009-08-12

INVISION SYSTEM

Applicant Inneroptic Technology, Inc.

K number K083728

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IYO 2009-06-18

CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Mcube Technology Co., Ltd.

K number K091518

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IYO 2009-05-26

GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND

Applicant Ge Medical Systems China Co., Ltd.

K number K091374

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IYO 2009-05-07

SPEQ ULTRASOUND SYSTEM

Applicant Signostics Pty, Ltd.

K number K090505

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IYO 2009-04-30

IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Saset (Chengdu), Inc.

K number K090059

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IYO 2009-03-13

VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND

Applicant Verathon Incorporated

K number K090214

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IYO 2009-01-09

ELLEX INNOVATIVE IMAGING EYE CUBED V4

Applicant Ellex, Inc.

K number K083061

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IYO 2008-12-22

SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER

Applicant Siemens Medical Solutions USA, Inc., Ultrasound DI

K number K081148

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IYO 2008-12-01

VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600

Applicant Verathon Incorporated

K number K082456

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IYO 2008-10-14

SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100

Applicant Sonocine, Inc.

K number K082543

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IYO 2008-10-08

S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM

Applicant Volcano Corporation

K number K082229

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IYO 2008-08-15

GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2

Applicant Ge Medical Systems Ultrasound and Primary Care Dia

K number K082185

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IYO 2008-08-07

MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS

Applicant U-System, Inc.

K number K080930

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