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Saige-Dx is a software device that processes screening mammograms using artificial intelligence to aid interpreting radiologists. By automatically detecting the presence or absence of soft tissue lesions and calcifications in mammography images, Saige-Dx can help improve reader performance, while also reducing reading time. The software takes as input a set of x-ray mammogram DICOM files from a single digital breast tomosynthesis (DBT) study and generates finding-level outputs for each image analyzed, as well as an aggregate case- level assessment. Saige-Dx processes both the DBT image stacks and the associated 2D images (full-field digital mammography (FFDM) and/or synthetic 2D images) in a DBT study. For each image, Saige-Dx outputs bounding boxes circumscribing any detected findings and assigns a Finding Suspicion Level to each finding, indicating the degree of suspicion that the finding is malignant. Saige-Dx uses the results of the finding-level analysis to generate a Case Suspicion Level, indicating the degree of suspicion for malignancy across the case. Saige-Dx encapsulates the finding and case-level results into a DICOM Structured Report (SR) object containing markings that can be overlaid on the original mammogram images using a viewing workstation and a DICOM Secondary Capture (SC) object containing a summary report of the Saige-Dx results.
Deephealth, Inc.
3.0
In Commercial Distribution

  • 00860005144013 ()
3.1

  • Radiology DICOM image processing application software
ASCEND InView v9.5 is a software-only medical device intended for use by trained clinicians to display medical images. The ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types. ASCEND InView v9.5 is for use by prescription only. The 9.5 update is equivalent to the prior release in functionality with updates to the user experience and playback performance for a better experience to the end user.
Ascend Cardiovascular LLC
9.5
In Commercial Distribution



  • Radiology DICOM image processing application software
Software module capable of taking an x-ray image generated by a CR or DR and producing a digitally enhanced image for projecting radiographic and/or fluoroscopic applications. AccuImaging is not indicated for use in mammography.
Radiology Information Systems, Inc.
AccuImaging
In Commercial Distribution

  • 00860009490628 ()


  • Radiology DICOM image processing application software
No Description
Ezra Ai, Inc.
FLHAI00PL01IF00IT00LB01
In Commercial Distribution

  • 00860010264614 ()


  • Radiology DICOM image processing application software
No Description
SYNOPSYS, INC.
2016.09
Not in Commercial Distribution

  • 00863520000307 ()


  • Radiology DICOM image processing application software
No Description
MARREK, INC.
1.30.0
In Commercial Distribution

  • 00862618000311 ()


  • Radiology DICOM image processing application software
The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.
CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
2.1
In Commercial Distribution

  • 00862611000356 ()


  • Radiology DICOM image processing application software
ImagenUniversal is a Windows application that allows physicians and healthcare professionals to correct myocardial perfusion PET images for transmission and emission misregistration, prompt gamma events, photon scatter and image noise.
CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
2.0
In Commercial Distribution

  • 00862611000332 ()


  • Radiology DICOM image processing application software
The ImagenMD with ImagenQ system is software that allows the user to visualize raw PET and/or PET/CT data, assist in evaluating the quality of PET scans, and perform quantitative measurements of tracer uptake to aid in the interpretation of myocardial perfusion PET images.
CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
V2.0
In Commercial Distribution

  • 00862611000325 ()


  • Radiology DICOM image processing application software
ImagenPRO is a software application installed on desktop computers with allows physicians and healthcare professionals to inspect, reconstruct, and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angels.
CARDIOVASCULAR IMAGING TECHNOLOGIES L.L.C.
2.2
In Commercial Distribution

  • 00862611000318 ()


  • Radiology DICOM image processing application software
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