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The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005601 ()
DSC017-01-US
- Basic diagnostic x-ray system application software
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.
The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005267 ()
D4D0181
- Basic diagnostic x-ray system application software
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.
The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005250 ()
DSC014-02-EU
- Basic diagnostic x-ray system application software
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.
The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005243 ()
DSC014-02-US
- Basic diagnostic x-ray system application software
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.
The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005236 ()
DSC014-01-EU
- Basic diagnostic x-ray system application software
The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CAD) software device intended to be used concurrently by radiologists while reading GE digital breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the CAD-enhanced 2D synthetic image is viewed on a mammography review workstation.
The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005229 ()
DSC014-01-US
- Basic diagnostic x-ray system application software
PowerLook Density Assessment is a software application intended for use with digital mammography
systems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue and
total breast area estimates. PowerLook Density Assessment provides these numerical values for each
breast as well as a density category to aid radiologists in the assessment of breast tissue
composition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive or
diagnostic aid.
Icad, Inc.
V2.1
In Commercial Distribution
- 00858012005205 ()
D70124, D70141 and D70126
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-09
In Commercial Distribution
- 00858012005175 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-08
In Commercial Distribution
- 00858012005168 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-07-EU
In Commercial Distribution
- 00858012005151 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-06
In Commercial Distribution
- 00858012005144 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-05-EU
In Commercial Distribution
- 00858012005137 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-04-EU
In Commercial Distribution
- 00858012005120 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-03-EU
In Commercial Distribution
- 00858012005113 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-12-EU
In Commercial Distribution
- 00858012005106 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC010-01-EU
In Commercial Distribution
- 00858012005090 ()
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Field Replacement System
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005083 ()
2376858-8-US
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Field Replacement System
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005076 ()
D4D0147
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005069 ()
DSC010-07-US
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005052 ()
DSC010-05-US
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005045 ()
DSC010-04-US
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005038 ()
DSC010-03-US
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005021 ()
DSC010-12-US
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005014 ()
DSC010-01-US
- Basic diagnostic x-ray system application software
The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.
Icad, Inc.
V7.2
In Commercial Distribution
- 00858012005007 ()
DS0206
- Basic diagnostic x-ray system application software
The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System. The software product described by this document is considered a sub-system of the MPTS.
The software product integrates with the following components of the MPTS system:
• X-ray generator & tube assembly
• Amorphous silicon flat-panel detector
• Electro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patient
The software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient location registration workflow will locate the treatment isocenter, defined in the patient anatomy, relative to the desired position in the treatment room through which the beam passes. The location of the treatment isocenter is established during treatment planning with 3D planning images (CT simulation images). The patient’s position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and previously acquired Digitally Reconstructed Radiographs or CTs.
There are two defined methods of registration,
1. Digitally Reconstructed Radiographs (DRRs) from 3D planning images are compared to the 2D images taken during patient setup in order to compare the patient anatomy with the expected location and orientation given by the DRRs. The registration tool is implemented to display both the downloaded DRRs, provided by the treatment planning system, and the display of the new 2D images, acquired by x-ray imaging system.
2. 3D planned volume images are compared to the CBCT volumetric (CTs) images taken during patient setup in order to compare the patient anatomy with the expected location and orientation. The regis
EhmetDx LLC
v.1.x
In Commercial Distribution
- 00866854000401 ()
n/a
- CT system application software
Control Unit Includes: Control Unit;Hardware Key;Carrying Case Keys 2 ; Adapters 3; Battery Charger; USB Cable;Information Manuals and Carrying Case
Medos International Sàrl
91-4205US
Not in Commercial Distribution
- 10886704064947 ()
- 10886704071426 ()
914205US
- Infusion pump programmer
No Description
PROTEUS DIGITAL HEALTH, INC.
SPC-2008
In Commercial Distribution
- 10856602005144 ()
- Medication adherence telemetric monitoring system, post-ingestion
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution
- 00840682134989 ()
- CT system application software
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution
- 00840682134972 ()
- CT system application software