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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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inHEART Models Shaper - 03770019599013

inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac images. It provides simple image review software functionality for basic medical image processing and manipulation, such as grayscale window and level, zoom and pan, image reformat, thresholding or user delineated geometric measurements (distance and volume). It is intended to be used by inHEART trained staffs. inHEART Models Shaper is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians). Clinicians are solely responsible for making all final patient management decisions.
INHEART
v1.2.0
Not in Commercial Distribution

  • 03770019599013 ()


  • Image segmentation application software

Floodlight MS U-Turn Test - 07613336193341

No Description
Roche Molecular Systems, Inc.
09342311001
In Commercial Distribution

  • 07613336193341 ()
09342311001

  • Self-care monitoring/reporting software

Floodlight MS U-Turn Test - 07613336193334

No Description
Roche Molecular Systems, Inc.
09342290001
In Commercial Distribution

  • 07613336193334 ()
09342290001

  • Self-care monitoring/reporting software

Floodlight MS Draw Shape Test - 07613336193297

No Description
Roche Molecular Systems, Inc.
09341935001
In Commercial Distribution

  • 07613336193297 ()
09341935001

  • Self-care monitoring/reporting software

Floodlight MS Draw Shape Test - 07613336193280

No Description
Roche Molecular Systems, Inc.
09341927001
In Commercial Distribution

  • 07613336193280 ()
09341927001

  • Self-care monitoring/reporting software

Floodlight MS Pinching Test - 07613336193259

No Description
Roche Molecular Systems, Inc.
09341889001
In Commercial Distribution

  • 07613336193259 ()
09341889001

  • Self-care monitoring/reporting software

Floodlight MS Pinching Test - 07613336193242

No Description
Roche Molecular Systems, Inc.
09341862001
In Commercial Distribution

  • 07613336193242 ()
09341862001

  • Self-care monitoring/reporting software

HANSATON scout 5.7 - 07613389736304

No Description
Sonova AG
n/a
In Commercial Distribution

  • 07613389736304 ()
058-5237-057

  • Audiometric/hearing device software

Aura:fit 5.7 - 07613389736281

No Description
Sonova AG
n/a
In Commercial Distribution

  • 07613389736281 ()
058-5180-057

  • Audiometric/hearing device software

Unitron TrueFit 5.7 USB - 07613389779950

No Description
Sonova AG
n/a
In Commercial Distribution

  • 07613389779950 ()
058-5268-057

  • Audiometric/hearing device software
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