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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Ascend Elite Gantry common top asm with UDI
GE HEALTHCARE JAPAN CORPORATION
Ascend Elite
In Commercial Distribution

  • 00195278718129 ()
RevolutionAscendElite

  • Full-body CT system
Revolution Maxima CT designated medical device
Hangwei GE Medical Systems Co., Ltd.
Maxima H
In Commercial Distribution

  • 00195278686718 ()


  • Full-body CT system
Spectral Color Overlay MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278630384 ()
5929649

  • CT system application software
SWMD DLIR Application for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.2
In Commercial Distribution

  • 00195278620453 ()
5928863

  • CT system application software
Revolution Eagle designated medical device
Hangwei GE Medical Systems Co., Ltd.
Eagle
In Commercial Distribution

  • 00195278403087 ()


  • Full-body CT system
Revolution Advance designated medical device
Hangwei GE Medical Systems Co., Ltd.
Advance
In Commercial Distribution

  • 00195278385215 ()
RevolutionAdvance

  • Full-body CT system
MaxFOV 2 Application Container for Smart Subscription
Hangwei GE Medical Systems Co., Ltd.
1.0
In Commercial Distribution

  • 00195278363947 ()


  • Full-body CT system
Revolution Frontier ES for EOL CT Designated medical device
Hangwei GE Medical Systems Co., Ltd.
Frontier ES
In Commercial Distribution

  • 00195278362247 ()


  • Full-body CT system
Revolution Frontier for EOL CT Designated medical device
Hangwei GE Medical Systems Co., Ltd.
Frontier MDR
In Commercial Distribution

  • 00195278362230 ()


  • Full-body CT system
MAR Application Container for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.1
In Commercial Distribution

  • 00195278303219 ()


  • CT system application software
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