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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