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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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Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. Vitrea provides visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images. It is a web-based imaging system that allows physicians to use PCs or notebook computers to remotely access to 2D and 3D advanced visualization using a Microsoft web-enabled browser. Vitrea modules include automated and semi-automated visualization and advanced quantification tools targeted for a specific study based on a protocol selected by the user. The automation is only intended to reduce the manual steps required by the user to analyze and quantify the data from the images; it is not intended to detect pathology or disease. The software provides imaging information as an assist to the physician.
Canon Medical Informatics, Inc.
6.9
In Commercial Distribution

  • 00853866003179 ()


  • Radiological PACS software
Software used by the clinician to interface with the WalkAide unit. This allows data collection, analysis and parameter modification in order to correctly time the applied stimulation to the user.
INNOVATIVE NEUROTRONICS, INC.
20-0603
In Commercial Distribution

  • 00858184006130 ()


  • Gait-enhancement electrical stimulation system, external
No Description
Synaptive Medical Inc
2.1
In Commercial Distribution

  • 00670082000504 ()
SYN-0867

  • Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
2.2
In Commercial Distribution

  • 00670082000627 ()
SYN-0867

  • Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
1.5
In Commercial Distribution

  • 00670082000375 ()
SYN-0027

  • Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
1.4
In Commercial Distribution

  • 00670082000191 ()
SYN-0027

  • Neurological stereotactic surgery system
No Description
Synaptive Medical Inc
1.3
In Commercial Distribution

  • 00670082000078 ()
SYN-0027

  • Neurological stereotactic surgery system
No Description
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007085 ()


  • CAD/CAM software
The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eonis PCR Reagent Kit for the semi-quantitative determination of TREC (signal joint T-cell receptor excision circle)and KREC (Kappa-deleting recombination excision circle), as well as the qualitative detection of the exon 7 of SMN1gene and RPP30 (Ribonuclease P/MRP Subunit P30) gene in DNA from blood specimens dried on a filter paper as an aidin screening newborns for Severe Combined Immunodeficiency (SCID), X-linked agammaglobulinemia (XLA) and SpinalMuscular Atrophy (SMA).
Wallac Oy
5020-1000
In Commercial Distribution

  • 06438147373901 ()
5020-1000

  • Human genomic analysis interpretive software IVD
SFW 9735911 STEALTH S8 STEREOTAXY
MEDTRONIC NAVIGATION, INC.
9735911
In Commercial Distribution

  • 00643169878211 ()


  • Neurological stereotactic surgery system
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