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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System, Image Processing, Radiological - Doctors Reading Station
Digisonics Inc
4.9
In Commercial Distribution

  • 00857050006021 ()


  • Radiological PACS software
System, Image Processing, Radiological - Doctors reading Station
Digisonics Inc
4.8
In Commercial Distribution

  • 00857050006014 ()


  • Radiological PACS software
Oasis is a software product designed to operate on an office PC. The product is intended for use by qualified medical personnel for the assessment of diagnostic medical images. The software allows for the processing, review, and transfer of scintigraphy camera output data as well as related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. The Oasis system displays processed images using an integrated computer. Oasis provides manual and automatic report creation plus the ability to view these reports remotely. Oasis also provides patient scheduling tools. The Oasis product is not intended to be used as a replacement for visual interpretation, nor as a diagnostic tool without the use of other clinical and laboratory information.
SEGAMI CORPORATION
V1
In Commercial Distribution

  • 00857198006006 ()


  • Gamma camera system application software
The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.
TRACKX TECHNOLOGY, LLC
ASC PROCEDURE KIT 1
In Commercial Distribution

  • 00857088008769 ()
980-3TX

  • Diagnostic x-ray digital imaging system workstation application software
Doctor's Reading Station
Digisonics Inc
4.0
In Commercial Distribution

  • 00857050006038 ()


  • Radiological PACS software
Doctors Review Station - System, Image processing, Radiological
Digisonics Inc
3.8
In Commercial Distribution

  • 00857050006007 ()


  • Radiological PACS software
Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue.
BRONCUS MEDICAL INC.
10009-2
In Commercial Distribution

  • 00856571007258 ()
10009-2

  • Virtual bronchoscopic navigation PACS software
Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue.
BRONCUS MEDICAL INC.
10009-1
In Commercial Distribution

  • 00856571007227 ()
10009-1

  • Virtual bronchoscopic navigation PACS software
LungPoint VBN Software is software installed on a desktop computer used to plan procedures and navigate to targets in the lung. The LungPoint Procedure Program offers real-time navigation guidance for use during the bronchoscopy procedure. The software allows visualization of the bronchial tree; helps guide the tools in or adjacent to the bronchial tree; allows visualization of a predefined target in lung tissue; and assists with placement of markers into soft lung tissue to guide radiosurgery and thoracic surgery.
BRONCUS MEDICAL INC.
30005
In Commercial Distribution

  • 00856571007173 ()
30005

  • Virtual bronchoscopic navigation PACS software
LungPoint Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue.
BRONCUS MEDICAL INC.
30009
In Commercial Distribution

  • 00856571007128 ()
30009

  • Virtual bronchoscopic navigation PACS software
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