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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The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.
NEOCOIL, LLC
32
In Commercial Distribution

  • 00856181003329 ()


  • Electrocardiograph, professional, multichannel
The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.
NEOCOIL, LLC
31
In Commercial Distribution

  • 00856181003312 ()


  • Electrocardiograph, professional, multichannel
RGSC
Varian Medical Systems Imaging Laboratory GmbH
1.1
In Commercial Distribution

  • 00856100006028 ()


  • Real-time position management respiratory gating system, optical
No Description
VARIAN MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 10856100006223 ()
  • 00856100006226 ()


  • Real-time position management respiratory gating system, optical
No Description
Varian Medical Systems Imaging Laboratory GmbH
2.0
In Commercial Distribution

  • 00856100006196 ()


  • Real-time position management respiratory gating system, optical
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.1
In Commercial Distribution

  • 00858012005915 ()
CT-102

  • CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution

  • 00858012005908 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158

  • CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution

  • 00858012005892 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158

  • CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution

  • 00858012005885 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158

  • CT system application software
The Imbio CT Lung Density Analysis Software is a set of image post-processing algorithms that perform image segmentation, registration, thresholding, and classification on CT images of human lungs. Imbio CT Lung Density Analysis Software is a command-line software application that analyzes DICOM CT lung image datasets and generates reports and DICOM output that show the lungs segmented and overlaid with color-codings representing the results of its thresholding and classification rules. It has simple file management functions for input and output. Imbio CT Lung Density Analysis Software does not interface directly with any CT or data collection equipment; instead the software imports data files previously generated by such equipment.
Imbio, LLC
5.1.1
In Commercial Distribution

  • 00850894007933 ()


  • Radiology DICOM image processing application software
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