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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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Viz CTP - 00811852030141

Viz CTP 1.4
VIZ.AI, INC.
1.4
Not in Commercial Distribution



  • Radiology DICOM image processing application software

Viz CTP - 00811852030103

Viz CTP 1.3
VIZ.AI, INC.
1.3
Not in Commercial Distribution



  • Radiology DICOM image processing application software

Viz CTP - 00811852030066

Viz CTP 1.2
VIZ.AI, INC.
1.2
Not in Commercial Distribution



  • Radiology DICOM image processing application software

Viz CTP - 00811852030288

Viz CTP v1.12 (2023-12-18)
VIZ.AI, INC.
Viz CTP Software
In Commercial Distribution



  • Radiology DICOM image processing application software

GearView QC - 00850677007327

No Description
HYLAND LLC
3X
In Commercial Distribution

  • 00850677007334 ()
  • 00850677007327 ()
  • 00850677007051 ()


  • Radiological PACS software

Oasis - 00857198006013

Oasis is a SaMD (Software as a Medical Device). It 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 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. The Oasis system is indicated for the processing and review of scintigraphy data and other 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 automatic and manual processing and displaying the medical image data 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 the processed images using an integrated computer. Oasis is a software-only medical device (a SaMD). Oasis does not directly or indirectly control any medical device that has contact with the user or patient. Oasis does not automate the diagnosis of a patient in any way. Oasis does not come into contact with patients and does not contain medicinal substances or non-viable animal/human tissues.
SEGAMI CORPORATION
V3
In Commercial Distribution



  • Gamma camera system application software

UltraMANAGEMENT UTILITY - 00860001148596

UltraRAD Product User Web Interface
ULTRARAD CORPORATION
2.0.2.8
In Commercial Distribution



  • Radiological PACS software

DAS-RS1 - 04573596213759

ULTRASOUND DATA ANALYSIS SYSTEM
FUJIFILM HEALTHCARE CORPORATION
DAS-RS1
In Commercial Distribution



  • Radiological PACS software

McKesson Radiology - 17540262020014

No Description
Change Healthcare Canada Company
12.3
In Commercial Distribution



  • Radiological PACS software

Neuroreader - 05700002060457

No Description
Brainreader ApS
2.5
Not in Commercial Distribution



  • Image segmentation application software
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