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Quantra® is a software application intended to calculate the volumetric breast density.
Hologic, Inc.
2.2
In Commercial Distribution
- 15420045510319 ()
R2LIC-2103-V2.2
- Radiology DICOM image processing application software
Cenova™ image analytics server is a high-performance application server that provides proprietary software applications to assist radiologists in the analysis of digital mammography images.
Hologic, Inc.
Cenova Server
Not in Commercial Distribution
- 15420045507395 ()
SW-06075
- 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
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
Software:
The True 3D Viewer Software is intended for processing, review, analysis, communication and media interchange of digital images acquired from CT, MRI and Ultrasound sources. It is also intended as software for pre-operative analysis of surgical options. The True 3D Viewer Software is designed for use only with performance tested hardware specified in the user documentation. The device is intended to be used by health care professionals, who are responsible for making all final patient management decisions.
ECHOPIXEL, INC.
EP-00003
In Commercial Distribution
- 00851325007003 ()
SW-0001-1601
- Radiology picture archiving and communication system workstation
- Radiology DICOM image processing application software
Morpheus® Control Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MOR0118
In Commercial Distribution
- 00852423006004 ()
MOR0118
- Ultrasound imaging system operator console
- Radiology DICOM image processing application software
- Urodynamic measurement system
No Description
Mediview Xr, Inc.
XR90-LQ-UPGRADE
In Commercial Distribution
- 00860006066383 ()
- Radiology DICOM image processing application software
- Electromagnetic surgical navigation device tracking system
No Description
Mediview Xr, Inc.
XR90-LQ-HMD01
In Commercial Distribution
- 00860006066376 ()
- Radiology DICOM image processing application software
- Electromagnetic surgical navigation device tracking system
No Description
Mediview Xr, Inc.
XR90-SYS-LOGIQ
In Commercial Distribution
- 00860006066369 ()
- Radiology DICOM image processing application software
- Electromagnetic surgical navigation device tracking system
No Description
Mediview Xr, Inc.
XR90-SYS
In Commercial Distribution
- 00850044606054 ()
- Radiology DICOM image processing application software
- Electromagnetic surgical navigation device tracking system