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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No Description
Ezra Ai, Inc.
FLHAI00PL01IF00IT00LB01
In Commercial Distribution

  • 00860010264614 ()


  • 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
VARIAN MEDICAL SYSTEMS, INC.
4.2
In Commercial Distribution

  • 00854393006039 ()


  • Radiology DICOM image processing application software
No Description
VARIAN MEDICAL SYSTEMS, INC.
3.2
In Commercial Distribution

  • 00854393006008 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
9.1
In Commercial Distribution

  • 00858012005977 ()


  • Radiology DICOM image processing application software
No Description
Icad, Inc.
V9
Not in Commercial Distribution

  • 00858012005946 ()


  • Radiology DICOM image processing application software
Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case. AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®.
PARASCRIPT, LLC
6.1
In Commercial Distribution

  • M760ACCFFDM00161 ()
ACCFFDM00161

  • Radiology DICOM image processing application software
Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case. AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®.
PARASCRIPT, LLC
7.0
In Commercial Distribution

  • M760ACCFFDM00170 ()
ACCFFDM00170

  • Radiology DICOM image processing application software
The qXR-LN (qXR_Lung_nodule) is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 6 to 30 mm in size. The device is intended to be used in the incidental adult population. It is designed to aid the physician to review the frontal (AP/PA) chest radiographs of adults acquired on digital radiographic systems as a second reader and be used with any DICOM viewer or PACS . qXR-LN provides adjunctive information only and is not a substitute for the original chest radiographic image
QURE.AI TECHNOLOGIES PRIVATE LIMITED
1.0.0
In Commercial Distribution

  • 00850057636024 ()


  • Radiology DICOM image processing application software
BRIT Lite 3.4.1.0
Brit Systems, LLC
3.4.1.0
In Commercial Distribution

  • 00850631008100 ()


  • Radiology DICOM image processing application software
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