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 | 00858012005168 | DSC010-08 | MYN | Analyzer, Medical Image | 2 | PowerLook AMP SLD Planmed | ||
18 | 00850008977237 | DSC018-07 | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook PRO+ 4GPU Tower Platform, US | ||
19 | 00850008977190 | DSC012-03 | LLZ | System, Image Processing, Radiological | 2 | PowerLook AMP with Density Assessment GE OUS | ||
20 | 00850008977084 | DSC011-03-US | LMD | System, Digital Image Communications, Radiological | 1 | PowerLook 10 PRO+, Rack Mount, US | ||
21 | 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 | ||
22 | 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 |
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 |
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 |