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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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Sun Nuclear Mammo 156 Phantom - B1361560

No Description
SUN NUCLEAR CORP.
156
In Commercial Distribution

  • B1361560 ()


  • Mammographic x-ray phantom, test object

NeuroQ - B133NEUROQ1

NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.75.20171019
In Commercial Distribution

  • B133NEUROQ1 ()


  • Neurosurgical ultrasound navigation system application software

NeuroQ - B133NEUROQ0

NeuroQ™ has been developed to aid in the assessment of human brain scans through quantification of mean pixel values lying within standardized regions of interest, and to provide quantified comparisons with brain scans derived from FDG-PET studies of defined groups having no identified neuropsychiatric disease or symptoms, i.e., asymptomatic controls (AC). The Program provides automated analysis of brain PET scans, with output that includes quantification of relative activity in 240 different brain regions, as well as measures of the magnitude and statistical significance with which activity in each region differs from mean activity values of brain regions in the AC database. The program can be used to compare activity in brain regions of individual scans between two studies from the same patient, between symmetric regions of interest within the brain PET study, and to perform an image fusion of the patients PET and CT data. The program can also be used to for assisting in the assessment of prognosis in patients undergoing dementia evaluation with respect to the likelihood of progression of symptomatic disease, to provide analysis of amyloid uptake levels in the brain, and to evaluate and to provide a quantitative analysis of uptake levels in basal ganglia structures of the brain. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.
SYNTERMED INCORPORATED
3.6.20131127
In Commercial Distribution

  • B133NEUROQ0 ()


  • Neurosurgical ultrasound navigation system application software

WebPAX® - B127WP90

WebPAX® is intended for use in the communication and storage of medical images. WebPAX® is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.
HEART IMAGING TECHNOLOGIES, LLC
9
In Commercial Distribution

  • B127WP90 ()
n/a

  • Medical image management system

Sonocubic 3D Ultrasound Software - B118314170

Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution

  • B118314170 ()


  • Ultrasound imaging system application software

Sonocubic 3D Ultrasound Software - B118314160

Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series.
MEDGE PLATFORMS INC
Classic
Not in Commercial Distribution

  • B118314160 ()


  • Ultrasound imaging system application software

Q-Tel RMS - 00812345029888

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
33193-104-50
Not in Commercial Distribution

  • 00812345029888 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029871

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
33193-103-50
Not in Commercial Distribution

  • 00812345029871 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029864

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-BAA-XXAAX
Not in Commercial Distribution

  • 00812345029864 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029833

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-JDG-BXAAX
Not in Commercial Distribution

  • 00812345029833 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029642

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELS-P-XX
Not in Commercial Distribution

  • 00812345029642 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029635

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELS-P-AC
Not in Commercial Distribution

  • 00812345029635 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029628

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELS-P-AB
Not in Commercial Distribution

  • 00812345029628 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029611

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELS-P-AA
Not in Commercial Distribution

  • 00812345029611 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029604

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-XXXX
Not in Commercial Distribution

  • 00812345029604 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029598

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-ACXX
Not in Commercial Distribution

  • 00812345029598 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029581

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-ACXA
Not in Commercial Distribution

  • 00812345029581 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029574

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-ACAX
Not in Commercial Distribution

  • 00812345029574 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029567

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-ACAA
Not in Commercial Distribution

  • 00812345029567 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029550

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-ABXX
Not in Commercial Distribution

  • 00812345029550 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029543

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-ABXA
Not in Commercial Distribution

  • 00812345029543 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029536

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-ABAX
Not in Commercial Distribution

  • 00812345029536 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029529

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-ABAA
Not in Commercial Distribution

  • 00812345029529 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029512

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-AAXX
Not in Commercial Distribution

  • 00812345029512 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029505

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-AAXA
Not in Commercial Distribution

  • 00812345029505 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029499

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-AAAX
Not in Commercial Distribution

  • 00812345029499 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029482

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
QTELM-P-AAAA
Not in Commercial Distribution

  • 00812345029482 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029475

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-AAA-XXAAX
Not in Commercial Distribution

  • 00812345029475 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029468

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-QAA-XXXAX
Not in Commercial Distribution

  • 00812345029468 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029451

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-PAA-XXXAX
Not in Commercial Distribution

  • 00812345029451 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029444

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-NAA-XXXAX
Not in Commercial Distribution

  • 00812345029444 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029437

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-MAA-XXXAX
Not in Commercial Distribution

  • 00812345029437 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029420

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-KAA-XXAAX
Not in Commercial Distribution

  • 00812345029420 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029413

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-JAA-XXAAX
Not in Commercial Distribution

  • 00812345029413 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029383

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-EAA-XXXAX
Not in Commercial Distribution

  • 00812345029383 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029376

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-DAA-XXXAX
Not in Commercial Distribution

  • 00812345029376 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029345

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-QAA-XXAAX
Not in Commercial Distribution

  • 00812345029345 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029338

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-NAA-XXAAX
Not in Commercial Distribution

  • 00812345029338 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029321

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-JAC-XXXAX
Not in Commercial Distribution

  • 00812345029321 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029314

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-JAA-XXAAX
Not in Commercial Distribution

  • 00812345029314 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029307

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-QAC-XXAAX
Not in Commercial Distribution

  • 00812345029307 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029291

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-PAC-XXAAX
Not in Commercial Distribution

  • 00812345029291 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029284

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-MAC-XXAAX
Not in Commercial Distribution

  • 00812345029284 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029277

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-AAC-XXAAX
Not in Commercial Distribution

  • 00812345029277 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029260

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-QAA-XXXAX
Not in Commercial Distribution

  • 00812345029260 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029253

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-QAA-XXAAX
Not in Commercial Distribution

  • 00812345029253 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029246

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-PAA-XXXAX
Not in Commercial Distribution

  • 00812345029246 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029239

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-PAA-XXAAX
Not in Commercial Distribution

  • 00812345029239 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029222

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-NAE-XXXAB
Not in Commercial Distribution

  • 00812345029222 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029215

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-NAA-XXXAX
Not in Commercial Distribution

  • 00812345029215 ()


  • Centralized patient monitor
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