Other products from "ICAD, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00858012005922 V3.4 D70141, D70142, D70160 "PowerLook Density Assessment 3.4 is a software application intended for use wit "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.  LLZ System, Image Processing, Radiological 2 PowerLook Density Assessment V3.4
2 00858012005854 V7.2 DSC017-04-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. MYN Analyzer,Medical Image 2 Powerlook PRO with SLD, GE, US
3 00858012005748 720823 F5410-30 Packaged Cutout 30mm, xFlex KPY Shield, Protective, Personnel 1 Packaged Cutout 30mm, xFlex
4 00858012005649 711110 SK1050 Surface Applicator Cone, 50mm JAD System, Therapeutic, X-Ray 2 Surface Applicator Cone, 50 mm
5 00858012005601 V7.2 DSC017-01-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. MYN Analyzer,Medical Image 2 PowerLook AMP PRO with SecondLook Digital
6 00858012005496 720269 AG3030 Vaginal Applicator 30 mm JAD System, Therapeutic, X-Ray 2 Vaginal Applicator, 30mm
7 00858012005410 720297 SK3510 Surface Applicator End Cap, 10 mm, 10-Pack JAD System, Therapeutic, X-Ray 2 (10) Applicator End Cap, 10 mm
8 00858012005373 710707 F5350-4 Rigid Shield 4 cm JAD System, Therapeutic, X-Ray 2 Rigid Shield 4 cm
9 00858012005342 720343 AB2063E Balloon Applicator, 5x7 cm Ellipsodial JAD System, Therapeutic, X-Ray 2 Balloon Applicator Kit
10 00858012005335 720332 AB2062 Balloon Applicator, 5-6 cm Spherical JAD System, Therapeutic, X-Ray 2 Balloon Applicator Kit
11 00858012005328 720331 AB2061 Balloon Applicator, 4-5 cm Spherical JAD System, Therapeutic, X-Ray 2 Balloon Applicator Kit
12 00858012005311 720342 AB2060 Balloon Applicator, 3-4 cm Spherical JAD System, Therapeutic, X-Ray 2 Balloon Applicator Kit
13 00858012005250 V1.1 DSC014-02-EU The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. MYN Analyzer,Medical Image 2 PowerLook PRO Tomo Detection and SLD, GE
14 00858012005236 V1.1 DSC014-01-EU The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. MYN Analyzer,Medical Image 2 PowerLook PRO Tomo Detection and SLD, GE
15 00858012005229 V1.1 DSC014-01-US The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. MYN Analyzer,Medical Image 2 PowerLook PRO Tomo Detection and SLD, GE
16 00858012005205 V2.1 D70124, D70141 and D70126 PowerLook Density Assessment is a software application intended for use with dig PowerLook Density Assessment is a software application intended for use with digital mammographysystems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue andtotal breast area estimates. PowerLook Density Assessment provides these numerical values for eachbreast as well as a density category to aid radiologists in the assessment of breast tissuecomposition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive ordiagnostic aid. LLZ System, Image Processing, Radiological 2 iReveal Breast Density Assessment
17 00850008977237 DSC018-07 LMD System, Digital Image Communications, Radiological 1 PowerLook PRO+ 4GPU Tower Platform, US
18 00850008977190 DSC012-03 LLZ System, Image Processing, Radiological 2 PowerLook AMP with Density Assessment GE OUS
19 00850008977084 DSC011-03-US LMD System, Digital Image Communications, Radiological 1 PowerLook 10 PRO+, Rack Mount, US
20 00858012005960 2.1 QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicio Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer 2 ProFound AI
21 00858012005823 V7.2 DSC017-03-ROW The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. MYN Analyzer,Medical Image 2 Powerlook PRO Hardware Upgrade, SLD
22 00858012005809 V7.2 DSC017-02-ROW The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. MYN Analyzer,Medical Image 2 Powerlook PRO Hardware Upgrade, SLD
23 00858012005793 V7.2 DSC017-02-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. MYN Analyzer,Medical Image 2 Powerlook PRO Hardware Upgrade, SLD
24 00858012005588 720772 F5201 Flexishield Radiation Absorber, Box KPY Shield, Protective, Personnel 1 Flexishield Radiation Absorber
25 00858012005694 720818 F5410-15 Packaged Cutout 15 mm, xFlex KPY Shield, Protective, Personnel 1 Packaged Cutout 15 mm, xFlex
26 00858012005526 750850 XP1200 Axxent Surface Controller JAD System, Therapeutic, X-Ray 2 Axxent Surface Controller
27 00858012005519 750050 XP1100 Axxent Standard Controller JAD System, Therapeutic, X-Ray 2 Axxent Standard Controller
28 00858012005403 710710 F5350-7 Rigid Shield 7 cm JAD System, Therapeutic, X-Ray 2 Rigid Shield 7 cm
29 00858012005304 720697 S7551 Axxent HDR X-Ray Source 50 cm HUT JAD System, Therapeutic, X-Ray 2 HDR X-ray Source 2.2
30 00858012005298 720684-02 S7601 Axxent HDR X-Ray Source 25 cm ESL JAD System, Therapeutic, X-Ray 2 HDR X-ray Source 2.2
31 00858012005281 720684 S7501 Axxent HDR X-Ray Source 25 cm HUT JAD System, Therapeutic, X-Ray 2 HDR X-ray Source 2.2
32 00858012005267 V1.1 D4D0181 The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. MYN Analyzer,Medical Image 2 PowerLook PRO Tomo Detection FRU
33 00858012005243 V1.1 DSC014-02-US The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. MYN Analyzer,Medical Image 2 PowerLook PRO with Tomo Detection, Upgrade, GE
34 00858012005175 DSC010-09 MYN Analyzer, Medical Image 2 PowerLook AMP SLD Agfa CR
35 00858012005113 DSC010-03-EU MYN Analyzer, Medical Image 2 PowerLook AMP SLD Siemens OUS
36 00850008977145 DSC018-06 LMD System, Digital Image Communications, Radiological 1 PowerLook PRO+ Rack-Mount, US
37 00850008977244 DSC018-07-UP LMD System, Digital Image Communications, Radiological 1 PowerLook PRO+ 4GPU Tower Upgrade, US
38 00850008977121 DSC018-04 LMD System, Digital Image Communications, Radiological 1 PowerLook PRO+ Hardware Platform GE, US
39 00858012005939 V2 QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicio Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer 2 PowerLook Tomo Detection (ProFound AI)
40 00858012005861 V7.2 D4D0192 The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. MYN Analyzer,Medical Image 2 Powerlook PRO with SLD, FRU
41 00858012005762 720825 F5410-KIT Packaged Cutout set,xFlex KPY Shield, Protective, Personnel 1 Packaged Cutout set,xFlex
42 00858012005731 720822 F5410-27 Packaged Cutout 27 mm, xFlex KPY Shield, Protective, Personnel 1 Packaged Cutout 27 mm, xFlex
43 00858012005717 720820 F5410-22 Packaged Cutout 22.2 mm, xFlex KPY Shield, Protective, Personnel 1 Packaged Cutout 22.2 mm, xFlex
44 00858012005595 710339 SK1000 Surface Applicator Set JAD System, Therapeutic, X-Ray 2 Surface Applicator Set
45 00858012005472 720267 AG3020 Vaginal Applicator 20 mm JAD System, Therapeutic, X-Ray 2 Vaginal Applicator, 20mm
46 00858012005427 720298 SK3520 Surface Applicator End Cap, 20 mm, 10-Pack JAD System, Therapeutic, X-Ray 2 (10) Applicator End Cap, 20 mm
47 00858012005274 710706 F5350-3 Rigid Shield 3 cm JAD System, Therapeutic, X-Ray 2 Rigid Shield 3 cm
48 00858012005212 V1.1 DS0244, D70130 The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. MYN Analyzer,Medical Image 2 PowerLook Tomo Detection Software
49 00858012005090 DSC010-01-EU MYN Analyzer, Medical Image 2 PowerLook AMP SLD GE OUS
50 00858012005083 V7.2 2376858-8-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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 MYN Analyzer,Medical Image 2 PowerLook AMP SLD FRU GE
Other products with the same Product Code "MYN"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00868430000027 5.2 Logicon Caries Detector is a software tool for assisting in the diagnosis of pro Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability. Logicon Caries Detector v5.2 has a "Prescan" feature, a method for automatically scanning all of the interproximal surfaces in a bitewing radiograph of posterior teeth for interproximal caries. It displays caries outlines for all surfaces in one radiograph on one screen and allows dentist to view (1) screen result details (density change and decay probability for each outline), (2) save clinically important results and (3) explore others with the ROI tool. Doctor can build his own final diagnostic results screen combining his own manual results and adjusted PreScan results. PreScan uses same caries detection algorithms as original device; but now automatically opens the V-tool on each interproximal surface. Logicon Caries Detector G. A INDUSTRIES
2 00868430000010 5.1 Logicon Caries Detector is a software tool for assisting in the diagnosis of pro Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability. PreScan is a New Feature in Logicon Caries Detector v5.1. It is a method for automatically scanning all the interproximal surfaces in a bitewing radiograph of posterior teeth for interproximal caries. It displays caries outlines for all surfaces in one radiograph on one screen and allows dentist to view (1) screen result details (density change and decay probability for each outline), (2) save clinically important results and (3) explore others with the ROI tool. Doctor can build his own final diagnostic results screen. PreScan uses same caries detection algorithms as original device; but now automatically opens the V-tool on each interproximal surface. Logicon Caries Detector G. A INDUSTRIES
3 00868430000003 4.0 Logicon Caries Detector is a software tool for assisting in the diagnosis of pro Logicon Caries Detector is a software tool for assisting in the diagnosis of proximal surface dental caries on radiographs acquired by a commercially available digital x-ray sensor system called RVG that is distributed in the United States by Carestream Dental, LLC. The software analyzes demineralization of the tooth material and compares it to a histological database of known caries problems to generate a probability of decay being present. A graphic interface displays an enlarged radiographic image outlining the potential lesion site on the tooth in question with separate plots of tooth density variations and lesion probability. Logicon Caries Detector G. A INDUSTRIES
4 00858012005878 V1.1 DSC014-03-US The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. PowerLook PRO with Tomo Detection ICAD, INC.
5 00858012005861 V7.2 D4D0192 The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. Powerlook PRO with SLD, FRU ICAD, INC.
6 00858012005854 V7.2 DSC017-04-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. Powerlook PRO with SLD, GE, US ICAD, INC.
7 00858012005847 V7.2 DSC017-04-ROW The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. PowerLook AMP PRO, SLD, GE, ROW ICAD, INC.
8 00858012005830 V7.2 DSC017-01-ROW The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. PowerLook AMP PRO, SLD, GE, ROW ICAD, INC.
9 00858012005823 V7.2 DSC017-03-ROW The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. Powerlook PRO Hardware Upgrade, SLD ICAD, INC.
10 00858012005816 V7.2 DSC017-03-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. PowerLook to PowerLook PRO Upgrade, US ICAD, INC.
11 00858012005809 V7.2 DSC017-02-ROW The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. Powerlook PRO Hardware Upgrade, SLD ICAD, INC.
12 00858012005793 V7.2 DSC017-02-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. Powerlook PRO Hardware Upgrade, SLD ICAD, INC.
13 00858012005663 V1.1 D70133 The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. PowerLook Tomo Detection and SecondLook Digital License ICAD, INC.
14 00858012005601 V7.2 DSC017-01-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. PowerLook AMP PRO with SecondLook Digital ICAD, INC.
15 00858012005267 V1.1 D4D0181 The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. PowerLook PRO Tomo Detection FRU ICAD, INC.
16 00858012005250 V1.1 DSC014-02-EU The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. PowerLook PRO Tomo Detection and SLD, GE ICAD, INC.
17 00858012005243 V1.1 DSC014-02-US The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. PowerLook PRO with Tomo Detection, Upgrade, GE ICAD, INC.
18 00858012005236 V1.1 DSC014-01-EU The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. PowerLook PRO Tomo Detection and SLD, GE ICAD, INC.
19 00858012005229 V1.1 DSC014-01-US The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. PowerLook PRO Tomo Detection and SLD, GE ICAD, INC.
20 00858012005212 V1.1 DS0244, D70130 The iCAD PowerLook® Tomo Detection Software is a computer-assisted detection (CA 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. PowerLook Tomo Detection Software ICAD, INC.
21 00858012005175 DSC010-09 PowerLook AMP SLD Agfa CR ICAD, INC.
22 00858012005168 DSC010-08 PowerLook AMP SLD Planmed ICAD, INC.
23 00858012005151 DSC010-07-EU PowerLook AMP SLD Philips OUS ICAD, INC.
24 00858012005144 DSC010-06 PowerLook AMP SLD Giotto ICAD, INC.
25 00858012005137 DSC010-05-EU PowerLook AMP SLD Hologic OUS ICAD, INC.
26 00858012005120 DSC010-04-EU PowerLook AMP SLD Fuji OUS ICAD, INC.
27 00858012005113 DSC010-03-EU PowerLook AMP SLD Siemens OUS ICAD, INC.
28 00858012005106 DSC010-12-EU PowerLook AMP SLD GE OUS Direct ICAD, INC.
29 00858012005090 DSC010-01-EU PowerLook AMP SLD GE OUS ICAD, INC.
30 00858012005083 V7.2 2376858-8-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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 PowerLook AMP SLD FRU GE ICAD, INC.
31 00858012005076 V7.2 D4D0147 The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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 PowerLook AMP SLD FRU ICAD, INC.
32 00858012005069 V7.2 DSC010-07-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. PowerLook AMP SLD Philips ICAD, INC.
33 00858012005052 V7.2 DSC010-05-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. PowerLook AMP SLD Hologic ICAD, INC.
34 00858012005045 V7.2 DSC010-04-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. PowerLook AMP SLD Fuji ICAD, INC.
35 00858012005038 V7.2 DSC010-03-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. PowerLook AMP SLD Siemens ICAD, INC.
36 00858012005021 V7.2 DSC010-12-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. PowerLook AMP SLD GE Direct ICAD, INC.
37 00858012005014 V7.2 DSC010-01-US The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. PowerLook AMP SLD GE US ICAD, INC.
38 00858012005007 V7.2 DS0206 The SecondLook Computer-Aided Detection (CAD) system for mammography is intended 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. SecondLook Digital (SLD) ICAD, INC.
39 00852491008023 1.0.0 Chest-CAD is a computer-assisted detection (CADe) software device designed as a Chest-CAD is a computer-assisted detection (CADe) software device designed as a concurrent reading aid to physicians. Chest-CAD uses machine learning techniques to identify, highlight, and categorize suspicious regions of interest (ROI) in adult chest X-rays. Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. 00852491008016 Chest-CAD IMAGEN TECHNOLOGIES, INC.
40 00196852162192 VCA01B Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions.Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older. Videa Caries Assist VIDEAHEALTH, INC.
41 B630QVCSIK1010344 10.10-3.4.4 Installation Kit for QVCAD System Release 3.4.4 with Debian 10.10 QVCAD System Installation Kit QVIEW MEDICAL
42 B630QVCSIK1010343 10.10-3.4.3 Installation Kit for QVCAD System Release 3.4.3 with Debian 10.10 QVCAD System Installation Kit QVIEW MEDICAL
43 B630QVCS344 3.4.4 Computer aided detection system of suspicious lesions in automated breast ultras Computer aided detection system of suspicious lesions in automated breast ultrasound images. QVCAD System QVIEW MEDICAL
44 B630QVCS343 3.4.3 QVCAD System QVIEW MEDICAL
45 B630QVCS342 3.4.2 QVCAD System QVIEW MEDICAL
46 B630QVCS34 3.4 QVCAD System QVIEW MEDICAL
47 B630QVCS33 3.3 QVCAD System QVIEW MEDICAL
48 60889978008698 Logicon Caries Detector 8008690 LOGICON SITE LIC (UP TO 10) W/IWT Logicon Caries Detector CARESTREAM HEALTH, INC.
49 60192156851628 Logicon Caries Detector 8008690 LOGICON SITE LIC (UP TO 10) W/IWT Logicon Caries Detector CARESTREAM DENTAL LLC
50 60192155942754 Logicon Caries Detector 5942750 CSD LOGICON CARIES DETECTOR Logicon Caries Detector CARESTREAM DENTAL LLC