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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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Cercare Medical Neurosuite with Capillary Function, release 2023-02-01 and prior
Cercare Medical A/S
CMN with Capillary Function (MR)
Not in Commercial Distribution

  • 05745000308019 ()


  • Radiological PACS software
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.
IMPACT APPLICATIONS, INC.
4
In Commercial Distribution

  • 00864127000349 ()


  • Cognitive assessment software
ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
1
Not in Commercial Distribution

  • 00864127000325 ()


  • Cognitive assessment software
Web-based dental Picture Archiving and Communications System (PACS)
REALCLOUD IMAGING, INC.
1
In Commercial Distribution

  • 00864058000302 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
R-2021.03
Not in Commercial Distribution

  • 00863520000383 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
Q-2020.06
Not in Commercial Distribution

  • 00863520000352 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
O-2018.12
Not in Commercial Distribution

  • 00863520000338 ()


  • Radiological PACS software
The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Kit
In Commercial Distribution

  • 00862290000333 ()


  • Cognitive assessment software
The T.O.V.A. microswitch precisely and accurately measures a subject's responses to the Test of Variables of Attention (T.O.V.A.), a computerized assessment of attention and inhibitory control. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
Microswitch
In Commercial Distribution

  • 00862290000319 ()


  • Cognitive assessment software
The Test of Variables of Attention (T.O.V.A.) USB Device is a USB-peripheral that precisely and accurate records and securely stores a subject's responses to the T.O.V.A. test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.
TOVA COMPANY, THE
USB Device
In Commercial Distribution

  • 00862290000302 ()


  • Cognitive assessment software
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