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

  • 04250337115281 ()
ICS0401

  • Medical image management system
joimax® Holding Arm, grey
Joimax GmbH
ICHA620G
In Commercial Distribution

  • 04250337102878 ()

  • 5 axes
ICHA620G

  • Medical image management system
Vitegra® Footswitch with 2 pedals
Joimax GmbH
ICFSHD001
In Commercial Distribution

  • 04250337100645 ()
ICFSHD001

  • Medical image management system
N/A
Carl Zeiss Vision GmbH
000000-2194-446
In Commercial Distribution

  • 04250668606663 ()
000000-2194-446

  • Medical image management system
N/A
Carl Zeiss Vision GmbH
000000-2433-519
In Commercial Distribution

  • 04250668606700 ()
000000-2433-519

  • Medical image management system
Vista Software CD
NATUS NEUROLOGY INCORPORATED
482-651600
In Commercial Distribution

  • 00382830041751 ()


  • Ultrasound imaging system application software
No Description
Xandar Kardian Korea Inc.
XK300
Not in Commercial Distribution

  • 08809988780001 ()


  • Multiple vital physiological parameter monitoring system, home-use
Monitor with DOX SPO2, NIBP, HR with Bluetooth
CRITICARE TECHNOLOGIES, INC.
eQuality 506DNB
In Commercial Distribution

  • D438506DNBUS0 ()


  • Multiple vital physiological parameter monitoring system, clinical
Magnetic Resonance Diagnostic Device
FUJIFILM CORPORATION
APERTO Lucent
In Commercial Distribution

  • 04573596200704 ()
APERTO Lucent

  • Full-body MRI system, permanent magnet
FerriSmart is a stand-alone software application that automatically analyses multi slice, spin echo MRI data sets encompassing the abdomen to determine the signal decay rate (R2) that is used to characterize iron loading in the liver, which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentrations in vivo. The software application is a measuring medical device intended to be hosted either in a cloud-based or on site hosted platform and used directly by the radiographer. It does not drive the MRI machine and does not come into direct contact with patients. The result report provides the patient’s average LIC reported in micromole and milligram per gram dry weight of liver. The images analysed are included in the report for review by the radiologist. The results are intended to assist in clinical diagnosis, and/or in making decisions concerning clinical management. FerriSmart is indicated to: • measure liver iron concentration in individuals with confirmed or suspected systemic iron overload • monitor liver iron burden in transfusion dependent thalassemia patients and patients with sickle cell disease receiving blood transfusions • aid in the identification and monitoring of non-transfusion-dependent thalassemia patients receiving therapy with deferasirox.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v01
In Commercial Distribution

  • 09369998038619 ()


  • MRI system application software
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