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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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No Description
STRYKER CORPORATION
1105
In Commercial Distribution

  • 07613327278224 ()
1105-000-000XE

  • Radiographic stretcher
No Description
STRYKER CORPORATION
1105
In Commercial Distribution

  • 07613327278194 ()
1105-000-000X

  • Radiographic stretcher
No Description
Anetic Aid USA LLC
QA3 Emergency Stretcher
In Commercial Distribution

  • 05051995000013 ()
21120

  • Radiographic stretcher
The R2*/T2* phantom is a medical device accessory intended to be used as an alternative to human test subject to avoid potential complications for an MRI centre in order to evaluate that the scanning protocol have been correctly set up for the analysis of cardiac R2* and T2* values using the CardiacT2* on 1.5T and 3T MRI scanners. The R2*/T2* Phantom consists of an amber bottle having 09 (nine) plastic tubes (30mL) of 0.8% Agarose (C24H38O19) gel doped with varying known concentrations (0.10 mM to 3.2 mM) of manganese chloride (MnCl2).
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000088 ()
-

  • MRI phantom, test object
Cardiovascular magnetic resonance (CMR) T2 mapping is key to quantifying myocardial inflammation. The T2CMR Phantom is made of nine (9) plastic tubes (30mL) containing different concentrations of nickel chloride (NiCl2) in agarose. T2CMR Phantom is provided to MRI Centres for the verification of T2-mapping stability across different 1.5T and 3T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T2 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000071 ()
-

  • MRI phantom, test object
The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 3.0T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000064 ()
-

  • MRI phantom, test object
The T1CMR Phantom contains a range of nickel chloride in agarose solutions that mimic cardiac T1 and T2 values. T1 measurement is used to calculate the extravascular volume fraction (ECV) to detect diffuse myocardial fibrosis. It is provided to MRI Centres for the verification of T1-mapping stability across different 1.5T scanners (different manufacturers and models) and to understand the feasibility of delivering a “T1 standard”.
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0
In Commercial Distribution

  • 09355529000033 ()
-

  • MRI phantom, test object
Sealed pack containing 15 vials of varying concentrations (0 mM to 3.2 mM) of aqueous manganese chloride solutions in 10 mM hydrochloride acid solution. It is intended to be used for verification / re-verification of correct MRI scanner sequence configuration for the use of R2-MRI Analysis System (FerriScan)
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
v1.0 (15 vials (0 to 3.2 mM))
In Commercial Distribution



  • MRI phantom, test object
No Description
FU SHUN HSING TECHNOLOGY CO., LTD.
E850
In Commercial Distribution

  • 04713157968500 ()


  • Radiographic stretcher
No Description
FU SHUN HSING TECHNOLOGY CO., LTD.
E200ix
In Commercial Distribution

  • 04713157966780 ()


  • Radiographic stretcher
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