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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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LOGIQ - 00195278722966

LOGIQ E10s R4
GE Ultrasound Korea Ltd.
E10s R4
In Commercial Distribution

  • 00195278722966 ()
5921403

  • General-purpose ultrasound imaging system

LOGIQ - 00195278722959

LOGIQ Fortis R4 HDU CONSOLE
GE Ultrasound Korea Ltd.
Fortis R4 HDU
In Commercial Distribution

  • 00195278722959 ()
6602000-10

  • General-purpose ultrasound imaging system

LOGIQ - 00195278722942

LOGIQ Fortis R4 LCD CONSOLE
GE Ultrasound Korea Ltd.
Fortis R4 LCD
In Commercial Distribution

  • 00195278722942 ()
6601000-10

  • General-purpose ultrasound imaging system

LOGIQ - 00195278722430

Magna R3 LOGIQ F Basic console
GE Medical Systems (China) Co.,Ltd.
LOGIQ F R3
In Commercial Distribution

  • 00195278722430 ()


  • General-purpose ultrasound imaging system

Versana - 00195278690401

Magna R3 LOTUS 4pp Basic console
GE Medical Systems (China) Co.,Ltd.
Premier LOTUS 4PP
In Commercial Distribution

  • 00195278690401 ()


  • General-purpose ultrasound imaging system

Versana - 00195278690395

Magna R3 VA Basic console
GE Medical Systems (China) Co.,Ltd.
Premier R3 VA
In Commercial Distribution

  • 00195278690395 ()


  • General-purpose ultrasound imaging system

Versana - 00195278690388

Magna R3 VS Basic console
GE Medical Systems (China) Co.,Ltd.
Premier R3 VS
In Commercial Distribution

  • 00195278690388 ()


  • General-purpose ultrasound imaging system

Venue Go - 00195278687777

Venue Go R5 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R5 UPG
In Commercial Distribution

  • 00195278687777 ()


  • General-purpose ultrasound imaging system

LOGIQ - 00195278680938

LOGIQ E10 R4 Console
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
E10 R4
In Commercial Distribution

  • 00195278680938 ()

  • Length: 901 Millimeter
  • Width: 585 Millimeter
  • Height: 1300 Millimeter


  • General-purpose ultrasound imaging system

Voluson - 00195278677587

Voluson Exp to BT24 UPG
GE Healthcare Austria GmbH & Co OG
Exp to BT24 UPG
In Commercial Distribution

  • 00195278677587 ()
5936797

  • General-purpose ultrasound imaging system

LOGIQ - 00195278674203

LOGIQ e TB Standard Console
GE Medical Systems (China) Co.,Ltd.
e TB
In Commercial Distribution

  • 00195278674203 ()


  • General-purpose ultrasound imaging system

LOGIQ - 00195278674197

LOGIQ e TP Standard Console
GE Medical Systems (China) Co.,Ltd.
e TP
In Commercial Distribution

  • 00195278674197 ()


  • General-purpose ultrasound imaging system

LOGIQ - 00195278664600

LOGIQ Totus
GE Ultrasound Korea Ltd.
Totus
In Commercial Distribution

  • 00195278664600 ()
5926013

  • General-purpose ultrasound imaging system

Voluson - 00195278633811

VOLUSON SIGNATURE 18
GE Ultrasound Korea Ltd.
Signature 18
In Commercial Distribution

  • 00195278633811 ()
Voluson-Signature-18

  • General-purpose ultrasound imaging system

Voluson - 00195278560155

Voluson SWIFT+ BT23
GE Ultrasound Korea Ltd.
SWIFT+ BT23
In Commercial Distribution

  • 00195278560155 ()
5919111

  • General-purpose ultrasound imaging system

Voluson - 00195278560124

Voluson SWIFT to BT23 UPG
GE Ultrasound Korea Ltd.
SWIFT to BT23 UPG
In Commercial Distribution

  • 00195278560124 ()
5919153

  • General-purpose ultrasound imaging system

Venue Go - 00195278516541

Venue Go R4 MD physical
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R4 UPG
In Commercial Distribution

  • 00195278516541 ()


  • General-purpose ultrasound imaging system

Venue Go - 00195278516510

Venue Go R4 Final Assembly
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R4
In Commercial Distribution

  • 00195278516510 ()


  • General-purpose ultrasound imaging system

Venue - 00195278516480

Venue R4 final Assembly
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R4
In Commercial Distribution

  • 00195278516480 ()


  • General-purpose ultrasound imaging system

Venue Fit - 00195278513014

Venue Fit R4 MD physical
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R4 UPG
In Commercial Distribution

  • 00195278513014 ()


  • General-purpose ultrasound imaging system

Voluson - 00195278473097

Voluson P6 BT22
GE Ultrasound Korea Ltd.
P6 BT22
In Commercial Distribution

  • 00195278473097 ()
VOLUSON-P6-BT22

  • General-purpose ultrasound imaging system

Voluson - 00195278473073

Voluson S8 BT22
GE Ultrasound Korea Ltd.
S8 BT22
In Commercial Distribution

  • 00195278473073 ()
VOLUSON-S8-BT22

  • General-purpose ultrasound imaging system

Voluson - 00195278473066

Voluson S8t BT22
GE Ultrasound Korea Ltd.
S8t BT22
In Commercial Distribution

  • 00195278473066 ()
VOLUSON-S8t-BT22

  • General-purpose ultrasound imaging system

Voluson - 00195278473042

Voluson S10 Expert BT22
GE Ultrasound Korea Ltd.
S10 Expert BT22
In Commercial Distribution

  • 00195278473042 ()
VOLUSON-S10Expert-BT22

  • General-purpose ultrasound imaging system

Voluson - 00195278473011

Voluson Performance to BT22 UPG
GE Ultrasound Korea Ltd.
Performance to BT22 UPG
In Commercial Distribution

  • 00195278473011 ()
Voluson-Performance-to-BT22-UPG

  • General-purpose ultrasound imaging system

LOGIQ - 00195278464668

LOGIQ P10 R4.5 HD
GE Ultrasound Korea Ltd.
P10 R4.5 HD
In Commercial Distribution

  • 00195278464668 ()


  • General-purpose ultrasound imaging system

LOGIQ - 00195278464620

LP10 R4 to R4.5 SW Conversion
GE Ultrasound Korea Ltd.
P10 R4 to R4.5 SW Conversion
In Commercial Distribution

  • 00195278464620 ()


  • General-purpose ultrasound imaging system

LOGIQ - 00195278405326

LOGIQ Fortis HDU Console
GE Ultrasound Korea Ltd.
FORTIS HDU
In Commercial Distribution

  • 00195278405326 ()


  • General-purpose ultrasound imaging system

Voluson - 00195278347497

Voluson Expert 22
GE Healthcare Austria GmbH & Co OG
Expert 22
In Commercial Distribution

  • 00195278347497 ()


  • General-purpose ultrasound imaging system

Voluson - 00195278347480

Voluson Expert 20
GE Healthcare Austria GmbH & Co OG
Expert 20
In Commercial Distribution

  • 00195278347480 ()


  • General-purpose ultrasound imaging system

Voluson - 00195278347473

Voluson Expert 18
GE Healthcare Austria GmbH & Co OG
Expert 18
In Commercial Distribution

  • 00195278347473 ()


  • General-purpose ultrasound imaging system

Versana - 00195278300096

Supra R2 basic console for Balance VA
GE Medical Systems (China) Co.,Ltd.
Balance R2 VA
In Commercial Distribution

  • 00195278300096 ()


  • General-purpose ultrasound imaging system

Versana - 00195278300034

Supra R2 basic console for Balance VS
GE Medical Systems (China) Co.,Ltd.
Balance R2 VS
In Commercial Distribution

  • 00195278300034 ()


  • General-purpose ultrasound imaging system

LOGIQ - 00195278236005

LOGIQ P10 R4 HD
GE Ultrasound Korea Ltd.
P10 R4 HD
In Commercial Distribution

  • 00195278236005 ()


  • General-purpose ultrasound imaging system

Venue Fit - 00195278194275

Venue Fit final Assy.
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R3
In Commercial Distribution

  • 00195278194275 ()


  • General-purpose ultrasound imaging system

LOGIQ - 00195278111272

LP9 R3 to R4 SW Conversion
GE Ultrasound Korea Ltd.
P9 R3 to R4 UPG
In Commercial Distribution

  • 00195278111272 ()


  • General-purpose ultrasound imaging system

Voluson - 00195278016836

No Description
GE Healthcare Austria GmbH & Co OG
E6 BT21
In Commercial Distribution

  • 00195278016836 ()


  • General-purpose ultrasound imaging system

Voluson - 00195278006837

VOLUSON SWIFT CONSOLE ASSY
GE Ultrasound Korea Ltd.
SWIFT
In Commercial Distribution

  • 00195278006837 ()


  • General-purpose ultrasound imaging system

Venue GO - 00195278005861

Venue Go R3 MD eDelivery or Physical Upgrade
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R3 UPG
In Commercial Distribution

  • 00195278005861 ()


  • General-purpose ultrasound imaging system

ACUSON Origin ICE Diagnostic Ultrasound System - 04068151012477

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11669400
In Commercial Distribution

  • 04068151012477 ()


  • General-purpose ultrasound imaging system

ACUSON P500 ICE Ultrasound System - 04068151001303

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11713064
In Commercial Distribution

  • 04068151001303 ()


  • General-purpose ultrasound imaging system

SONON ULTRASOUND IMAGING SYSTEM - 08809489920012

No Description
Healcerion Co., Ltd.
300L
In Commercial Distribution

  • 08809489920012 ()


  • General-purpose ultrasound imaging system

SONON ULTRASOUND IMAGING SYSTEM - 08809489920005

No Description
Healcerion Co., Ltd.
SONON 300C
In Commercial Distribution

  • 08809489920005 ()


  • General-purpose ultrasound imaging system

RS85 Diagnostic Ultrasound System - 08809521029833

No Description
SAMSUNG MEDISON CO., LTD.
USS-RS85F4K/US
In Commercial Distribution

  • 08809521029833 ()


  • General-purpose ultrasound imaging system

HS50 / HS60 Diagnostic Ultrasound System - 08809521028805

No Description
SAMSUNG MEDISON CO., LTD.
USS-HS5PF3M/US
In Commercial Distribution

  • 08809521028805 ()


  • General-purpose ultrasound imaging system

HS50 / HS60 Diagnostic Ultrasound System - 08809521028614

No Description
SAMSUNG MEDISON CO., LTD.
USS-HS5PB3M/US
In Commercial Distribution

  • 08809521028614 ()


  • General-purpose ultrasound imaging system

HS50 / HS60 Diagnostic Ultrasound System - 08809521028423

No Description
SAMSUNG MEDISON CO., LTD.
USS-HS5NL3M/US
In Commercial Distribution

  • 08809521028423 ()


  • General-purpose ultrasound imaging system

HS50 / HS60 Diagnostic Ultrasound System - 08809521028232

No Description
SAMSUNG MEDISON CO., LTD.
USS-HS5NB3M/US
In Commercial Distribution

  • 08809521028232 ()


  • General-purpose ultrasound imaging system

HS50 / HS60 Diagnostic Ultrasound System - 08809521028041

No Description
SAMSUNG MEDISON CO., LTD.
USS-HS5PF4M/US
In Commercial Distribution

  • 08809521028041 ()


  • General-purpose ultrasound imaging system

HS50 / HS60 Diagnostic Ultrasound System - 08809521027853

No Description
SAMSUNG MEDISON CO., LTD.
USS-HS5PB4M/US
In Commercial Distribution

  • 08809521027853 ()


  • General-purpose ultrasound imaging system
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