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Digital Imaging software used with digital sensors to take x-ray images of teeth by dentists for diagnostic viewing of the images, archiving, and electronic transmission of images.
SUNI MEDICAL IMAGING, INC.
Advanced Imaging
In Commercial Distribution
- 00851067007026 ()
400-1242S
- General-purpose dental x-ray system application software
No Description
MULTIFUNCTIONAL IMAGING, LLC
v1
In Commercial Distribution
- 00860059002109 ()
- PET system application software
No Description
Icad, Inc.
2.1
In Commercial Distribution
- 00858012005960 ()
- Basic diagnostic x-ray system application software
No Description
Icad, Inc.
V2
Not in Commercial Distribution
- 00858012005939 ()
- Basic diagnostic x-ray system application software
"PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid.
Icad, Inc.
V3.4
In Commercial Distribution
- 00858012005922 ()
D70141, D70142, D70160
- Basic diagnostic x-ray system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005915 ()
CT-102
- CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution
- 00858012005908 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
- CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution
- 00858012005892 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
- CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution
- 00858012005885 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
- CT 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
- 00858012005878 ()
DSC014-03-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
- 00858012005861 ()
D4D0192
- 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
- 00858012005854 ()
DSC017-04-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
- 00858012005847 ()
DSC017-04-ROW
- 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
- 00858012005830 ()
DSC017-01-ROW
- 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
- 00858012005823 ()
DSC017-03-ROW
- 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
- 00858012005816 ()
DSC017-03-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
- 00858012005809 ()
DSC017-02-ROW
- 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
- 00858012005793 ()
DSC017-02-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
- 00858012005663 ()
D70133
- Basic diagnostic x-ray system application software
PowerLook Density Assessment 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
- 00858012005656 ()
DSC012
- 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
- 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