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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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myVisionTrack - 00860003376102

Vision testing application - android version
Brightinsight, Inc.
1
In Commercial Distribution

  • 00860003376102 ()


  • Vision self-testing software

ChartCheck - 00860001672749

ChartCheck assists in quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, imaging, and documentation data in a simple, web-based interface.
Radformation, Inc
1.2
In Commercial Distribution

  • 00860001672749 ()


  • Radiation therapy software

AutoContour - 00860001672732

AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in preparation for radiation therapy treatment planning.
Radformation, Inc
2.0
In Commercial Distribution

  • 00860001672732 ()


  • Radiation therapy software

ClearCalc - 00860001672725

ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm.
Radformation, Inc
2.0
In Commercial Distribution

  • 00860001672725 ()


  • Radiation therapy software

EZFluence - 00860001672718

EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photo treatment fields.
Radformation, Inc
2.3
In Commercial Distribution

  • 00860001672718 ()


  • Radiation therapy software

ClearCheck - 00860001672701

ClearCheck is intended for quality assessment of radiotherapy treatment plans.
Radformation, Inc
2.0
In Commercial Distribution

  • 00860001672701 ()


  • Radiation therapy software

Interacoustics - 05711117199765

No Description
Interacoustics A/S
Viot Suite
In Commercial Distribution

  • 05711117199765 ()


  • Camera application software

Interacoustics - 05711117180497

No Description
Interacoustics A/S
2D-VOGfw
In Commercial Distribution

  • 05711117180497 ()


  • Camera application software

Chronicle Web - 00860007318726

No Description
Qr8 Health Inc
CHR-COG-W10
Not in Commercial Distribution

  • 00860007318726 ()


  • Cognitive assessment software

Cognition Snapshot v2.0 - 00860007318719

No Description
Qr8 Health Inc
SNP-COG-20
Not in Commercial Distribution

  • 00860007318719 ()


  • Cognitive assessment software
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