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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))
- MRI phantom, test object
No Description
CORSCIENCE GmbH & Co. KG
CS20401
In Commercial Distribution
- 04251341900054 ()
- Bioelectrical signal analysis software
No Description
COCHLEAR LIMITED
Osia 2 System
In Commercial Distribution
- 09321502045124 ()
P1343785
- Hearing implant system sound processor activation kit
exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.
exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.
The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets.
exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
exocad GmbH
3.1 Rijeka
In Commercial Distribution
- 04260521365026 ()
- Dental treatment application software
exoplan is a medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patient’s anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient’s anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.
exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.
The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets.
exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
exocad GmbH
3.0 Galway
In Commercial Distribution
- 04260521365019 ()
- Dental treatment application software
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (4)
Not in Commercial Distribution
- 00850023296351 ()
Shoe insole size 4 (men 13.0 to 15.0)
- Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (3)
Not in Commercial Distribution
- 00850023296344 ()
Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 to 12.50)
- Pressure monitoring insole