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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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No Description
Thought Technology Ltd.
SA7900AR
In Commercial Distribution

  • 07540191000647 ()


  • Biofeedback system application software
Kinesis Balance is a smartphone application for assessment of balance and falls risk in older adults. The product is software based and uses simple clinical questionnaires and the sensors embedded in a smartphone to measure balance and assess risk of falls. The application is intended to be used by older adults and their carers in the home.
KINESIS
2.0.1
In Commercial Distribution

  • 05391542950027 ()


  • Posturography system application software
No Description
Balance Tracking Systems Incorporated
Version 7
In Commercial Distribution

  • 00860010129111 ()


  • Posturography system application software
FeetMe Evaluation mobileAndroid application version 3.Y.Z.
FEETME
3
In Commercial Distribution

  • 03760349820062 ()


  • Posturography system application software
IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology. IB Lab LAMA is not indicated for use on radiographs on which Ankle Arthroplasties and/or Unicompartmental Knee Arthroplasties are present.
IB Lab GmbH
V1.06
In Commercial Distribution

  • 09120105730730 ()


  • X-ray image interpretive software
No Description
Visage Imaging GmbH
1.0
In Commercial Distribution

  • 04251332930008 ()


  • Radiological PACS software
This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.
FUJIFILM CORPORATION
EW10-EC02
In Commercial Distribution

  • 04547410541199 ()


  • Endoscopic video image interpretive software
FEops HEARTguide ALPACA
FEops
3.1.0
In Commercial Distribution

  • 05430002070087 ()
05430002070087

  • Radiology DICOM image processing application software
FEops HEARTguide ALPACA 3.0.1 / 3.0.2
FEops
3.0.1
Not in Commercial Distribution

  • 05430002070063 ()


  • Radiology DICOM image processing application software
No Description
ULTROMICS LIMITED
Core 2.0
In Commercial Distribution

  • 05060634690027 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
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