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 2008-07-16

EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE

Applicant Shenzhen Emperor Electronic Technology Co. , Ltd.

K number K081873

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IYO 2008-07-09

NUWAV

Applicant Laborie Medical Technologies, Corp.

K number K081781

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IYO 2008-06-24

ZURA TEE SYSTEM

Applicant Imacor, LLC

K number K080223

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IYO 2008-06-04

MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc., Ultrasound DI

K number K081121

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IYO 2008-05-23

ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202

Applicant B-K Medical Aps

K number K081154

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IYO 2008-05-16

SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM

Applicant Shantou Institute of Ultrasonic Instuments

K number K081110

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IYO 2008-02-14

TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO

Applicant Teratech Corp.

K number K080234

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IYO 2008-01-23

VASCUVIEW ULTRASOUND SYSTEM

Applicant Escalon Medical Corp.

K number K080049

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IYO 2007-12-19

MASTER-VU

Applicant Sonomed, Inc.

K number K073196

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IYO 2007-12-18

ACUSON X300 ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K072676

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IYO 2007-10-17

GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

Applicant General Electric Co.

K number K072797

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IYO 2007-09-26

ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3

Applicant Boston Scientific Corp

K number K072517

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IYO 2007-08-24

CHISON, MODEL 8300

Applicant Chison Medical Imaging Co., Ltd.

K number K072210

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IYO 2007-08-03

MYLAB30, MODEL 7300

Applicant Esaote, S.p.A.

K number K071996

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IYO 2007-07-03

SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER

Applicant Sounmed, Inc.

K number K071156

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IYO 2007-05-22

SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS

Applicant Siemens Medical Solutions USA, Inc.

K number K071314

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IYO 2007-05-18

SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6

Applicant C.R. Bard, Inc.

K number K071204

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IYO 2007-05-17

BLADDERSCAN BVI 9400 ULTRASOUND

Applicant Verathon Incorporated

K number K071217

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IYO 2007-05-08

SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Sonosite,Inc.

K number K071134

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IYO 2007-05-02

CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM

Applicant Shantou Institute of Ultrasonic Instuments

K number K070982

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IYO 2007-04-19

B-SCAN PLUS

Applicant Accutome Ultrasound, Inc.

K number K070943

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IYO 2007-04-17

INTERSON USB ULTRASOUND PROBE SYSTEM

Applicant Regulatory Management Services

K number K070907

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IYO 2007-04-11

POD B-SCAN

Applicant Starfish Product Engineering, Inc.

K number K070884

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IYO 2007-03-23

DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

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

K number K070526

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IYO 2007-03-09

ORISON EMBRACE SYSTEM

Applicant Orison Corporation

K number K070477

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IYO 2007-03-05

ULTRASOUND SCANNER PROFOCUS, MODEL 2202

Applicant B-K Medical Aps

K number K070077

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IYO 2007-01-31

ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200

Applicant Meda , Ltd.

K number K063472

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IYO 2007-01-29

ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200

Applicant Meda , Ltd.

K number K063433

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IYO 2006-11-21

LONGPORT EPISCAN, MODEL-I-200

Applicant Longport, Inc.

K number K062571

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IYO 2006-11-14

MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K063085

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IYO 2006-08-10

VOLCANO S51 FAMILY OF IMAGING SYSTEMS

Applicant Volcano Corporation

K number K061215

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IYO 2006-08-07

MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM

Applicant Esaote Europe B.V.

K number K061755

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IYO 2006-07-14

ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO

Applicant Shimadzu Medical Systems

K number K061641

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IYO 2006-07-12

GE VOLUSON E8 ULTRASOUND SYSTEM

Applicant General Electric Co.

K number K061682

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IYO 2006-06-23

VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM

Applicant Volcano Corporation

K number K060483

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IYO 2006-06-06

CTS-7700

Applicant Shantou Institute of Ultrasonic Instuments

K number K061083

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IYO 2006-06-01

DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

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

K number K061189

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IYO 2006-05-04

DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

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

K number K060949

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IYO 2006-04-19

IVIEW

Applicant Ondemandsoft

K number K053306

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IYO 2006-04-11

VUMAX

Applicant Sonomed, Inc.

K number K060626

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IYO 2006-04-07

SEEKER/SPARK ULTRASOUND SYSTEM

Applicant Ardent Sound, Inc.

K number K060800

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IYO 2005-12-09

MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900

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

K number K053346

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IYO 2005-12-07

MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001

Applicant Mediwatch, Ltd.

K number K053325

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IYO 2005-12-02

IN VISION GOLD WITH SPIN VISION, MODEL 891 SV

Applicant Volcano Corporation

K number K052348

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IYO 2005-09-14

AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS

Applicant U-Systems, Inc.

K number K052355

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IYO 2005-08-19

VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001

Applicant Volcano Corporation

K number K051920

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IYO 2005-08-09

DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

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

K number K052113

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IYO 2005-08-03

AVISO OPHTHALMIC ULTRASOUND SYSTEM

Applicant Quantel Medical

K number K051851

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IYO 2005-06-17

FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A

Applicant Toshiba America Medical Systems, In.C

K number K051500

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IYO 2005-06-03

ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM

Applicant Science Surgical Corporation

K number K051304

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IYO 2005-05-26

ULTRASONIC BIO-MICROSCOPE, MODEL P60

Applicant Paradigm Medical Industries, Inc.

K number K050980

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IYO 2005-03-28

PACHPEN PACHYMETER, MODEL 24-5100

Applicant Accutome, Inc.

K number K050552

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IYO 2005-03-22

VOYAGER PERSONAL IMAGING DEVICE

Applicant Ardent Sound, Inc.

K number K050551

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IYO 2005-02-09

SONALIS, MODEL 2000

Applicant 3g Ultrasound, Inc.

K number K043189

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IYO 2005-02-08

CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE

Applicant Chison Medical Imaging Co., Ltd.

K number K050167

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IYO 2005-01-11

DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

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

K number K043563

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IYO 2004-12-23

SONATA 3-D IMAGING ACCESSORY, MODEL 3DS

Applicant Tetrad Corp.

K number K042620

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IYO 2004-12-10

PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000

Applicant Micromedical Devices, Inc.

K number K043287

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IYO 2004-12-09

OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER

Applicant Olympus Medical Systems Corporation

K number K043275

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IYO 2004-11-17

NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A

Applicant Toshiba America Medical Systems, In.C

K number K043078

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IYO 2004-11-12

SENSATOUCH

Applicant Aluna Management Co., Ltd.

K number K042250

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IYO 2004-11-10

ACCUPACH V

Applicant Accutome Ultrasound, Inc.

K number K042752

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IYO 2004-11-10

VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM

Applicant Volcano Therapeutics, Inc.

K number K042188

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IYO 2004-10-28

ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER)

Applicant Reichert, Inc.

K number K042831

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IYO 2004-10-27

SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS

Applicant Siemens Medical Solutions USA, Inc.

K number K042833

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IYO 2004-10-04

PHILIPS IU22 ULTRASOUND SYSTEM

Applicant Philips Ultrasound, Inc.

K number K042540

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IYO 2004-09-02

TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM

Applicant Envisioneering, LLC

K number K041639

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IYO 2004-08-16

I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND

Applicant Innovative Imaging, Inc.

K number K041947

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IYO 2004-06-10

SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

Applicant Sonoscape Company Limited

K number K041455

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IYO 2004-05-17

VUE 100 ULTRASOUND IMAGING SYSTEM

Applicant Mobilsonic, Inc.

K number K040652

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IYO 2004-04-13

E-Z SCAN AB5500+

Applicant Sonomed, Inc.

K number K040668

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IYO 2004-03-26

ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY

Applicant Aloka Co., Ltd.

K number K040719

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IYO 2004-03-09

SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS

Applicant Siemens Medical Solutions USA, Inc.

K number K040502

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IYO 2003-12-24

PORTASCAN BLADDER SCANNER, MODEL PA00146

Applicant Mediwatch Plc

K number K033906

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IYO 2003-12-15

TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L

Applicant Pie Medical

K number K033604

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IYO 2003-11-07

DGH 55 HANDHELD PACHYMETER (PACHMATE)

Applicant Dgh Technology, Inc.

K number K033385

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IYO 2003-10-10

ACCUSONIC A-SCAN MODEL, 24-4000

Applicant Accutome, Inc.

K number K032956

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IYO 2003-09-30

ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM

Applicant Aloka Co. Ltd USA

K number K032875

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IYO 2003-09-11

FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM

Applicant U-Systems, Inc.

K number K032640

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IYO 2003-07-21

SITE-RITE IV ULTRASOUND SYSTEM

Applicant Dymax Corp

K number K032135

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IYO 2003-06-24

UF BRACHYTHERAPY STAND

Applicant University of Florida

K number K023430

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IYO 2003-06-20

HF MODULE WITH TRANSDUCERS

Applicant Ophthalmic Technologies, Inc.

K number K031391

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IYO 2003-03-27

OTI SCAN WITH TRANSDUCERS

Applicant Ophthalmic Technologies, Inc.

K number K030770

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IYO 2003-03-26

DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM

Applicant Diagnostic Ultrasound Corp.

K number K030763

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IYO 2003-03-21

POD PAC-20M

Applicant Portable Ophthalmic Devices, Inc.

K number K030610

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IYO 2003-01-10

A-SCAN 100

Applicant Ophthalmic Technologies, Inc.

K number K024114

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IYO 2002-12-11

HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS

Applicant Hudson Diagnostic Imaging, LLC

K number K022928

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IYO 2002-11-20

SONOREAL 3D

Applicant Bio Medi Com

K number K023473

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IYO 2002-11-01

ULTRASOUND SCANNER, TYPE 1101

Applicant B-K Medical A/S

K number K023457

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IYO 2002-10-08

ARTEMIS

Applicant Ultralink, LLC

K number K021333

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IYO 2002-08-15

BLADDERSCAN BVI 6100

Applicant Diagnostic Ultrasound Corp.

K number K022153

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IYO 2002-07-10

ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124

Applicant Aloka Co., Ltd.

K number K020668

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IYO 2002-06-21

CINESCAN S

Applicant Quantel Medical

K number K021683

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IYO 2002-05-09

SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN

Applicant Tomtec Imaging Systems GmbH

K number K020561

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IYO 2002-05-03

ECHOSCAN, MODEL US-1800

Applicant Nidek, Inc.

K number K020876

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IYO 2002-04-19

50S TRINGA ULTRASOUND IMAGING SYSTEM

Applicant Pie Medical

K number K020112

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IYO 2002-04-10

UD-1000 ULTRASONIC A/B SCANNER

Applicant Tomey Corp. USA

K number K020151

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IYO 2002-04-08

AL-2000 COMBINED BIOMETER AND PACHYMETER

Applicant Tomey Corp.

K number K012803

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IYO 2002-04-04

ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS

Applicant Echotech 3D Imaging Systems, Inc.

K number K013088

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IYO 2002-03-04

SONOREAL 3D SYSTEM

Applicant Bio Medi Com

K number K020068

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