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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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CARESCAPE CENTRAL STATION V2 MAS 700 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V2 Standard MAS 700
Not in Commercial Distribution

  • 00840682109604 ()


  • Centralized patient monitor
No Description
Lunit Inc.
1.1
In Commercial Distribution

  • 08800076000162 ()


  • X-ray image interpretive software
No Description
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000148 ()


  • X-ray image interpretive software
No Description
Lunit Inc.
1.1
In Commercial Distribution

  • 08800076000056 ()


  • X-ray image interpretive software
The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force and moment data from a balance plate. The balance plate is seated in a dynamic chassis that can move in both translational and rotational directions, under control of the Balance Advantage (BA) software program. The BA software contains both assessment and training modules that can be used during each session. Assessments have set run-times during which they collect data after the “Start” button is pressed, while trainings have customizable run-times varying from 1 minute to 15 minutes. The system is intended to be used by trained clinicians in a hospital or clinical (physical therapy or ENT) environment who operate the software and ensure the safety of the patient. The patient being assessed on the system is placed in a harness. There are three different harness sizes with varying weight limits that can be purchase with the system; standard harness supports up to 300lbs, pediatric is up to 100lbs, and the bariatric supports up to 450lbs. The mechanical components of the system are designed to support up to 500lb patients.
BERTEC CORPORATION
97P-0036
In Commercial Distribution

  • 00850017250079 ()


  • Posturography system platform
Bertec Balance Advantage Prime IVR system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Immersive Virtual Reality (IVR) to enhance clinical balance assessment and training.
BERTEC CORPORATION
97P-0072
In Commercial Distribution

  • 00850017250062 ()


  • Posturography system platform
Bertec Balance Advantage Portable Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0002
In Commercial Distribution

  • 00850017250055 ()


  • Posturography system platform
Bertec Balance Advantage Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0001
In Commercial Distribution

  • 00850017250048 ()


  • Posturography system platform
Bertec Balance Advantage Functional system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0005
In Commercial Distribution

  • 00850017250031 ()


  • Posturography system platform
Bertec Balance Advantage Portable Functional system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
BERTEC CORPORATION
97P-0066
In Commercial Distribution

  • 00850017250024 ()


  • Posturography system platform
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