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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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Ponto 3 SuperPower, R, WHS
Oticon Medical AB
M52655
In Commercial Distribution

  • 05712149011896 ()
M52655

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, L, WHS
Oticon Medical AB
M52654
In Commercial Distribution

  • 05712149011889 ()
M52654

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, R, CBE
Oticon Medical AB
M52653
In Commercial Distribution

  • 05712149011872 ()
M52653

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, L, CBE
Oticon Medical AB
M52652
In Commercial Distribution

  • 05712149011865 ()
M52652

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, R, MBR
Oticon Medical AB
M52651
In Commercial Distribution

  • 05712149011858 ()
M52651

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, L, MBR
Oticon Medical AB
M52650
In Commercial Distribution

  • 05712149011841 ()
M52650

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, R, DBL
Oticon Medical AB
M52649
In Commercial Distribution

  • 05712149011834 ()
M52649

  • Anchored bone-conduction hearing implant system
RSI-MRI+ is standalone software that is used by radiologists, urologists, and other clinicians to assist with analysis and interpretation of medical images. RSI-MRI+ accepts DICOM images using supported protocols and performs automatic post-acquisition analysis of diffusion-weighted magnetic resonance imaging (DWI) data and optional automated fusion of derived image data with anatomical T2-weighted MR images. Some of the features of RSI-MRI+ include: • Restricted Signal Map: The derived image data produced by RSI-MRI+ includes an enhanced DWI map (the Restricted Signal Map), which demonstrates improved conspicuity of restricted diffusion compared to standard DWI maps. • Color Fusion Series: RSI-MRI+ can be configured to produce a color fusion series which overlays the Restricted Signal Map intensity onto the anatomical T2-weighted image series. • Automated Prostate Segmentation: RSI-MRI+ uses artificial intelligence (AI) powered by a deep learning algorithm to automatically segment the prostate on anatomical T2-weighted images. The segmentation result is provided in the separate Prostate Segmentation Series. • Automated Segmentation Report: RSI-MRI+ generates a report of segmentation volume and images of the segmented prostate as a colored outline on the anatomical image. • Export: RSI-MRI+ outputs are provided in standard DICOM format, which is compatible with most third-party commercial PACS workstation software. NOTE: The RSI-MRI+ supported protocols differ from PI-RADS v2.1 in that they have lower inplane resolution for T2W images and thicker slices for the GE DW
CORTECHS LABS INC
1.1
In Commercial Distribution

  • 00860000004817 ()


  • Radiology DICOM image processing application software
PERFORATED TRAY WITH FEET 242x252x80MM
BAHADIR USA LLC
Y380.07F
In Commercial Distribution

  • 00859982006964 ()


  • Instrument tray, reusable
PERFORATED TRAY WITH FEET 242x252x60MM
BAHADIR USA LLC
Y380.05F
In Commercial Distribution

  • 00859982006957 ()


  • Instrument tray, reusable
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