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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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InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest.
Infervision Medical Technology Co., Ltd
5.0.2.5
In Commercial Distribution

  • 00850003095042 ()


  • X-ray image interpretive software
  • Diagnostic x-ray digital imaging system workstation
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH).
Infervision US Inc
1.1.0.0
In Commercial Distribution

  • 00850003095011 ()


  • Diagnostic x-ray digital imaging system workstation
  • X-ray image interpretive software
Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest.
Infervision US Inc
2.1.2.1
In Commercial Distribution

  • 00850003095004 ()


  • X-ray image interpretive software
  • Diagnostic x-ray digital imaging system workstation
Cassette Printer with AutoLoader
SAKURA FINETEK U.S.A., INC.
9020
In Commercial Distribution

  • 00615233082374 ()
9020

  • Cell morphology analyser IVD, automated/semi-automated
  • Computed radiography digital imaging scanner
ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies. The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).
CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
3.0
In Commercial Distribution

  • 00862611000349 ()


  • SPECT system application software
  • Radiology DICOM image processing application software
The ImagenSPECT™ system is a software application that provides a processing environment for the analysis and display of cardiac SPECT images. The results of this processing may be used in determining the presence of cardiac diseases. Data for ImagenSPECT is derived from a nuclear medicine gamma camera. The resulting datasets may be either planar or 3D tomograms of patient anatomy.
CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
2.0
In Commercial Distribution

  • 00862611000301 ()


  • SPECT system application software
  • Radiology DICOM image processing application software
Brand Name: PlaDuo PRO System (PlaDuo System) Model: PlaDuo PRO System
shenb Co., Ltd.
PlaDuo PRO System
In Commercial Distribution

  • 08800017101422 ()


  • Nitrogen plasma skin surface treatment system
  • Argon-enhanced electrosurgical system gas delivery unit
No Description
shenb Co., Ltd.
PlaDuo
In Commercial Distribution

  • 08800017101118 ()


  • Nitrogen plasma skin surface treatment system
  • Argon-enhanced electrosurgical system gas delivery unit
M8048A Flexible Module Server is capable of housing up to 8 single width modules. Handles - where required - and basic mounting hardware are included.
Philips Medizin Systeme Böblingen GmbH
Flexible Module Server
In Commercial Distribution

  • 00884838021853 ()
862461

  • Patient monitoring system module rack
TigerView software version 8.4.1
TELEVERE SYSTEMS, LLC
8.4.1
In Commercial Distribution

  • 00851800007108 ()
TigerView 8.4.1

  • Basic diagnostic x-ray system application software
  • Camera application software
  • Multidisciplinary medical image management software
  • General-purpose dental x-ray system application software
  • Radiological PACS software
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