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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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syngo.MR Cardiology - 04056869012735

SW version VA30B
Siemens Healthcare GmbH
11234863
In Commercial Distribution

  • 04056869012735 ()


  • MRI system application software

syngo.MR General - 04056869012728

SW version VA30B
Siemens Healthcare GmbH
11234862
In Commercial Distribution

  • 04056869012728 ()


  • MRI system application software

microphone - 04250337119944

joimax® Microphone
Joimax GmbH
ICWM0055
In Commercial Distribution

  • 04250337119944 ()
ICWM0055

  • Medical image management system

Vitegra® - 04250337119937

Vitegra® Pro Upgrade
Joimax GmbH
ICS1710.100
In Commercial Distribution

  • 04250337119937 ()
ICS1710.100

  • Medical image management system

Vitegra® - 04250337119852

Vitegra® pro with footswitch
Joimax GmbH
ICS1710FS
In Commercial Distribution

  • 04250337119852 ()

  • visual integration image capture system
ICS1710FS

  • Medical image management system

Vitegra® - 04250337119845

Vitegra® pro
Joimax GmbH
ICS1710
In Commercial Distribution

  • 04250337119845 ()

  • visual integration image capture system
ICS1710

  • Medical image management system

Vitegra® - 04250337119821

Adapter plate
Joimax GmbH
JESTTH
In Commercial Distribution

  • 04250337119821 ()
JESTTH

  • Medical image management system

Natus - 00382830041751

Vista Software CD
NATUS NEUROLOGY INCORPORATED
482-651600
In Commercial Distribution

  • 00382830041751 ()


  • Ultrasound imaging system application software

Vitegra® - 04250337119685

joimax® Vitegra® DICOM module
Joimax GmbH
ICS0401D
In Commercial Distribution

  • 04250337119685 ()

  • License key for enabling the DICOM functionality
ICS0401D

  • Medical image management system

Vitegra® - 04250337117698

joimax® Vitegra® tablet mount set
Joimax GmbH
JESTTHS
In Commercial Distribution

  • 04250337117698 ()

  • VESA 75/100, charging station
JESTTHS

  • Medical image management system

Vitegra® - 04250337117346

joimax® Vitegra® Wireless Microphone Set
Joimax GmbH
ICWSR400S
In Commercial Distribution

  • 04250337117346 ()
ICWSR400S

  • Medical image management system

Vitegra® - 04250337116165

joimax® Vitegra® Tablet
Joimax GmbH
ICS0401T
In Commercial Distribution

  • 04250337116165 ()
ICS0401T

  • Medical image management system

Vitegra® - 04250337115298

joimax® Vitegra® Visual Integration System
Joimax GmbH
ICS0401S
In Commercial Distribution

  • 04250337115298 ()

  • Fully integrated Full HD documentation system
ICS0401S

  • Medical image management system

Vitegra® - 04250337115281

joimax® Vitegra® Control Unit
Joimax GmbH
ICS0401
In Commercial Distribution

  • 04250337115281 ()
ICS0401

  • Medical image management system

Vitegra® - 04250337106371

Footswitch for Vitegra®3 for Video/Image capture
Joimax GmbH
ICFSV002
In Commercial Distribution

  • 04250337106371 ()
ICFSV002

  • Medical image management system

Vitegra® - 04250337106364

Vitegra®3 IO-Modul Image/Video Capture
Joimax GmbH
ICS1900IO
In Commercial Distribution

  • 04250337106364 ()
ICS1900IO

  • Medical image management system

Vitegra® - 04250337105312

joimax® Vitegra® Wireless Microphone Set
Joimax GmbH
ICWSR400
In Commercial Distribution

  • 04250337105312 ()
ICWSR400

  • Medical image management system

Vitegra® - 04250337105299

joimax® Rotate and Slope Adaptor for Vitegra®
Joimax GmbH
ICRA410G
In Commercial Distribution

  • 04250337105299 ()
ICRA410G

  • Medical image management system

Vitegra® - 04250337103950

Vitegra®3 Visual Integration System
Joimax GmbH
ICS1900
In Commercial Distribution

  • 04250337103950 ()
ICS1900

  • Medical image management system

Vitegra® - 04250337102878

joimax® Holding Arm, grey
Joimax GmbH
ICHA620G
In Commercial Distribution

  • 04250337102878 ()

  • 5 axes
ICHA620G

  • Medical image management system

Vitegra® - 04250337100645

Vitegra® Footswitch with 2 pedals
Joimax GmbH
ICFSHD001
In Commercial Distribution

  • 04250337100645 ()
ICFSHD001

  • Medical image management system

Genoray - 08809244061226

No Description
GENORAY CO., LTD.
ZEN-PX4
In Commercial Distribution

  • 08809244061226 ()


  • Portable basic diagnostic x-ray system, digital

Genoray - 08809244061035

The Multiple Name for PORT-XII is ZEN-PX2.
GENORAY CO., LTD.
PORT-XII
In Commercial Distribution

  • 08809244061035 ()


  • Portable basic diagnostic x-ray system, digital

NuCart - 04061591001322

The NuCART® is a mobile display and image management platform intended to be used by healthcare providers in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of videosignals from source devices to monitors. It is tailored for use with a C-arm and Endo-Cam in MIS surgery suites,Ambulatory Surgery Centers, Urology, GI and other suites.
Ondal Medical Systems GmbH
Nucart
In Commercial Distribution

  • 04061591001322 ()


  • Medical image management system

Genoray - 08809244061202

No Description
GENORAY CO., LTD.
PORT-X IV
In Commercial Distribution

  • 08809244061202 ()


  • Portable basic diagnostic x-ray system, digital

Vscan - 00195278884749

Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software

Vscan - 00195278884725

Vscan Air R3 for Android
GE Vingmed Ultrasound AS
Air R3 for Android
In Commercial Distribution

  • 00195278884725 ()


  • Ultrasound imaging system application software

Digital Expert Access - 00195278707741

DE MR Remote Scan Modality Connectivity Executable_1.5.6-RS
GE HEALTHCARE
with Remote scanning for MR
In Commercial Distribution

  • 00195278707741 ()
5941611

  • MRI system application software

Vscan - 00195278640574

Vscan Air R2 Upgrade kit
GE Vingmed Ultrasound AS
Air R2 CL
In Commercial Distribution

  • 00195278640574 ()


  • Ultrasound imaging system application software

Vscan - 00195278640550

Vscan Air R2 for iOS
GE Vingmed Ultrasound AS
Air R2 for iOS
In Commercial Distribution

  • 00195278640550 ()


  • Ultrasound imaging system application software

EchoPAC - 00195278504326

MD EchoPAC Plug-in v206
GE Vingmed Ultrasound AS
Plug-in v206
In Commercial Distribution

  • 00195278504326 ()


  • Ultrasound imaging system application software

EchoPAC - 00195278504302

MD EchoPAC Software Only v206
GE Vingmed Ultrasound AS
Software Only v206
In Commercial Distribution

  • 00195278504302 ()


  • Ultrasound imaging system application software

PORTRAIT HUB01 - 00195278093998

HUB, AMBULATORY HUB DEVICE ASSEMBLY
GE Healthcare Finland Oy
HUB01
In Commercial Distribution

  • 00195278093998 ()
2096437-001

  • Wearable multiple vital physiological parameter monitor

DaTQUANT - 00195278011343

No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
2.0
In Commercial Distribution

  • 00195278011343 ()


  • SPECT system application software

Venue Sprint - 00195278754011

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

  • 00195278754011 ()


  • Ultrasound imaging system application software

Universal Viewer - 00195278644039

MD UV 8.1 MEDICAL DEVICE
GE HEALTHCARE
8.1
In Commercial Distribution

  • 00195278644039 ()


  • Medical image management system

Vscan - 00195278640567

Vscan Air R2 for Android
GE Vingmed Ultrasound AS
Air R2 for Android
In Commercial Distribution

  • 00195278640567 ()


  • Ultrasound imaging system application software

Portrait VSM - 00195278561312

Portrait VSM ATO MODEL
Ge Medical Systems Information Technologies, Inc.
MVC101
In Commercial Distribution

  • 00195278561312 ()
6660000-666

  • Multiple vital physiological parameter monitoring system, clinical

Universal Viewer - 00195278379610

MD UV 8 MEDICAL DEVICE
GE HEALTHCARE
8
In Commercial Distribution

  • 00195278379610 ()


  • Medical image management system

CARESCAPE ONE - 00195278288639

CARESCAPE ONE MBZ323 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
MBZ323
In Commercial Distribution

  • 00195278288639 ()
2087075-300

  • Multiple vital physiological parameter monitoring system, clinical
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