System, Imaging, Pulsed Doppler, Ultrasonic

FDA product code IYN · 1075 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1550
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-10-10 – 2026-09-25

IYN 2006-11-22

MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER

Applicant Hitachi Medical Corp.

K number K061608

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IYN 2006-11-03

SONARA; SONARA/TEK

Applicant Viasys Healthcare, Inc.

K number K060421

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IYN 2006-11-02

APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0

Applicant Toshibamedical Systems Corporation

K number K063130

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IYN 2006-09-18

DIGI-LITE TCD DEVICE

Applicant Rimed , Ltd.

K number K062578

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IYN 2006-08-18

HD11 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Philips Ultrasound, Inc.

K number K062247

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IYN 2006-08-17

SIEMENS ACUSON X500 ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K061980

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IYN 2006-08-07

MEDCHANNEL HTS SYSTEM

Applicant Medchannel, LLC

K number K061831

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IYN 2006-08-04

SONIX ULTRASOUND SCANNER

Applicant Ultrasonix Medical Corporation

K number K061827

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IYN 2006-07-27

ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO

Applicant Shimadzu Medical Systems

K number K061643

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IYN 2006-07-25

ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO

Applicant Shimadzu Medical Systems

K number K061637

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IYN 2006-07-21

ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K061946

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IYN 2006-07-03

GE VIVID - I

Applicant General Electric Co.

K number K061525

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IYN 2006-06-30

CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM

Applicant Shantou Institute of Ultrasonic Instruments (Siui

K number K061488

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IYN 2006-06-22

NEMIO XG, SAA-580A

Applicant Toshiba America Medical Systems, In.C

K number K061605

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IYN 2006-06-14

SIGMA 5000 SERIES, IMAGIC

Applicant Kontron Medical Systems Sas

K number K061437

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IYN 2006-06-01

GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000

Applicant General Electric Co.

K number K061129

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IYN 2006-05-19

MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100

Applicant Esaote, S.p.A.

K number K060827

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IYN 2006-05-16

SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Medison Co., Ltd.

K number K061213

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IYN 2006-05-05

NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM

Applicant Nodecrest, LLC

K number K060112

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IYN 2006-05-03

GE LOGIQ P5 AND A5

Applicant General Electric Co.

K number K060993

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IYN 2006-03-31

GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX

Applicant General Electric Co.

K number K060542

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IYN 2006-01-24

ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Medison Co., Ltd.

K number K060087

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IYN 2006-01-24

PIONEER TC8080, COMPANION III

Applicant Viasys Neuro Care

K number K053648

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IYN 2006-01-13

ALOKA SD-3500 ULTRASOUND SYSTEM

Applicant Aloka Co., Ltd.

K number K060059

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IYN 2006-01-03

SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Medison Co., Ltd.

K number K053530

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IYN 2005-12-16

GE VOLUSON I

Applicant General Electric Co.

K number K053435

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IYN 2005-12-16

MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM

Applicant Pie Medical

K number K053154

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IYN 2005-12-09

EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER

Applicant Hitachi Medical Corp.

K number K053258

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IYN 2005-11-23

SONOLINE G60 S ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K052894

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IYN 2005-11-16

SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM

Applicant Kontron Medical Systems Sas

K number K053084

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IYN 2005-11-16

SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)

Applicant Sonosite,Inc.

K number K053069

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IYN 2005-11-10

ACUSON CYPRESS ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K052331

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IYN 2005-10-31

ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Medison Co., Ltd.

K number K052911

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IYN 2005-10-17

MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150

Applicant Esaote, S.p.A.

K number K052805

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IYN 2005-09-22

ACUSON SEQUOIA ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K052410

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IYN 2005-09-21

GE LOGIQ 7 ULTRASOUND BT05

Applicant General Electric Co.

K number K052441

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IYN 2005-08-11

SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES)

Applicant Sonosite,Inc.

K number K052109

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IYN 2005-08-09

SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS

Applicant Sonoscape Company Limited

K number K052042

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IYN 2005-07-28

POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB.

Applicant Multigon Industries, Inc.

K number K051739

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IYN 2005-07-20

MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100

Applicant Esaote, S.p.A.

K number K051837

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IYN 2005-06-16

GE VIVID 7 WITH OR WITHOUT SUFFIX

Applicant GE Medical Systems

K number K051449

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IYN 2005-06-03

TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER

Applicant Teratech Corp.

K number K051334

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IYN 2005-06-01

MYLAB 70 ULTRASOUND IMAGING SYSTEM

Applicant Esaote, S.p.A.

K number K051308

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IYN 2005-05-13

ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K051139

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IYN 2005-05-05

DOPPLER-BOX

Applicant Compumedics Germany Gmgh

K number K051085

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IYN 2005-04-01

ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100

Applicant Shimadzu Medical Systems

K number K050510

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IYN 2005-02-28

7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350

Applicant Esaote, S.p.A.

K number K050326

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IYN 2005-02-23

XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A

Applicant Toshiba America Medical Systems, In.C

K number K050380

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IYN 2005-02-17

FUKUDA DENSHI MODEL UF-850XTD

Applicant Fukuda Denshi USA, Inc.

K number K050363

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IYN 2005-02-15

MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K050240

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IYN 2005-02-15

USCOM 1A

Applicant Uscom, Ltd.

K number K043139

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IYN 2005-02-02

GE LOGIQ TWIN

Applicant General Electric Co.

K number K050126

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IYN 2005-01-28

SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM

Applicant Kontron Medical Systems Sas

K number K050099

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IYN 2005-01-25

MYLAB 15 / MYLAB 20, MODEL 2700

Applicant Pie Medical

K number K043588

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IYN 2005-01-14

ULTRASOUND SCANNER MINI FOCUS, MODEL 1402

Applicant B-K Medical A/S

K number K043554

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IYN 2005-01-13

SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K050034

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IYN 2005-01-13

ULTRASOUND SCANNER PRO FOCUS, MODEL 2202

Applicant B-K Medical A/S

K number K043524

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IYN 2005-01-12

SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)

Applicant Sonosite,Inc.

K number K043559

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IYN 2005-01-06

HD11 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Philips Ultrasound, Inc.

K number K043535

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IYN 2004-12-21

SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Medison Co., Ltd.

K number K043455

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IYN 2004-12-21

TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM

Applicant Sonosite,Inc.

K number K043452

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IYN 2004-11-30

ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM

Applicant Aloka Co., Ltd.

K number K043196

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IYN 2004-11-16

SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K043016

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IYN 2004-10-20

MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K042770

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IYN 2004-10-20

SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000

Applicant Sonoscape Company Limited

K number K042369

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IYN 2004-09-16

ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER

Applicant Ultrasonix Medical Corporation

K number K042326

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IYN 2004-08-16

CYPRESS ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K042055

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IYN 2004-08-13

ACUSON CV70 CARDIOVASCULAR SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K042044

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IYN 2004-08-04

HEMO-DOP

Applicant Dwl Elektronische Systeme GmbH

K number K041915

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IYN 2004-07-30

ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM

Applicant Aloka Co. Ltd USA

K number K041916

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IYN 2004-07-23

GE LOGIQ 7 ULTRASOUND BT04

Applicant Ge Medical Systems Ultrasound and Primary Care Dia

K number K041813

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IYN 2004-07-23

PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS

Applicant Pie Medical

K number K041675

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IYN 2004-07-08

GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04

Applicant General Electric Co.

K number K041688

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IYN 2004-07-02

GE VIVID 7 BT04

Applicant General Electric Co.

K number K041552

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IYN 2004-06-10

SSA-770A, APLIO VERSION 5.5

Applicant Toshibamedical Systems Corporation

K number K041499

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IYN 2004-06-10

ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000

Applicant Hudson Diagnostic Imaging, LLC

K number K040926

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IYN 2004-06-07

SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K041319

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IYN 2004-03-31

ULTRASOUND IMAGING SYSTEM, MODEL 7300

Applicant Esaote, S.p.A.

K number K040596

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IYN 2004-02-27

LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM

Applicant Larsen & Toubro Limited

K number K040409

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IYN 2004-02-20

GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587

Applicant Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc

K number K040251

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IYN 2004-01-28

SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS

Applicant Siemens Medical Solutions USA, Inc.

K number K040060

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IYN 2004-01-08

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Philips Ultrasound, Inc.

K number K034003

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IYN 2003-11-05

TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464

Applicant Sonosite,Inc.

K number K033367

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IYN 2003-10-31

FUKUDA DENSHI MODEL FF SONIC UF-750XT

Applicant Fukuda Denshi USA, Inc.

K number K033209

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IYN 2003-10-30

GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X

Applicant Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc

K number K032656

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IYN 2003-10-29

ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM

Applicant Aloka Co., Ltd.

K number K033311

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IYN 2003-10-23

GE MARLIN ULTRASOUND

Applicant General Electric Co.

K number K033139

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IYN 2003-10-22

GE LOGIQ BOOK

Applicant General Electric Co.

K number K032477

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IYN 2003-10-21

GE LOGIQ 5 PRO OR EXPERT

Applicant General Electric Co.

K number K032974

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IYN 2003-10-17

VIEWMATE ULTRASOUND IMAGING SYSTEM

Applicant Ep Medsystems

K number K031066

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IYN 2003-10-16

SONOLINE ANTARES WITH CLARIFY VE

Applicant Siemens Medical Solutions USA, Inc.

K number K033196

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IYN 2003-10-10

GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM

Applicant General Electric Co.

K number K032620

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IYN 2003-08-22

EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER

Applicant Hitachi Medical Systems America, Inc.

K number K032503

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IYN 2003-08-06

SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Medison America, Inc.

K number K032329

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IYN 2003-08-06

SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Toshiba America Medical Systems, In.C

K number K032281

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IYN 2003-07-25

GE LOGIQ 7, MODEL 2354858

Applicant General Electric Co.

K number K032182

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IYN 2003-07-21

SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K032114

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IYN 2003-07-18

ACUSON CV70 CARDIOVASCULAR SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K032111

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IYN 2003-06-09

GE VIVID 7, MODEL FC0003XX

Applicant General Electric Co.

K number K031663

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IYN 2003-05-30

MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS

Applicant Medison America, Inc.

K number K031552

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