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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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Engage Medical Device Alarm Notification System (EMDAN) - 00860002177748

No Description
STRYKER CORPORATION
EMDAN 2.3.0
In Commercial Distribution

  • 00860002177748 ()
910-01956

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177731

No Description
STRYKER CORPORATION
EMDAN 2.1.1
In Commercial Distribution

  • 00860002177731 ()
910-01954

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177724

No Description
STRYKER CORPORATION
EMDAN 1.10.0
In Commercial Distribution

  • 00860002177724 ()
910-01952

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177717

No Description
STRYKER CORPORATION
EMDAN 2.2.0
In Commercial Distribution

  • 00860002177717 ()
910-01955

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177700

No Description
STRYKER CORPORATION
EMDAN 2.1.0
In Commercial Distribution

  • 00860002177700 ()
910-01953

  • Alarm application 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
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