No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M722XD20239B200370 | 1.2.0 | ClearRead Bone Suppress on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
2 | M722T18304V182920 | 3.3.3 | ClearRead CT | LLZ,OEB | System, Image Processing, Radiological,Lung Computed Tomography System, Computer System, Image Processing, Radiological,Lung Computed Tomography System, Computer-Aided Detection | 2 | ClearRead CT | |
3 | M722XD22145T212210 | 4.0.0 | ClearRead Compare on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Compare | |
4 | M722XD21224L212210 | 3.0.0 | ClearRead Confirm Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
5 | M722XD21224E212210 | 3.0.0 | ClearRead Enhance Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Enhance Docker | |
6 | M722XD21224C212210 | 6.1.0 | ClearRead Detect Docker | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
7 | M722XD21224B212210 | 4.0.0 | ClearRead Bone Suppress Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
8 | M722XD21012B203200 | 3.0.0 | ClearRead Bone Suppress on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
9 | M722XD20239C200370 | 1.2.0 | ClearRead Detect on Docker Platform | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
10 | M722XD20104C20370 | 5.3.1 | ClearRead Detect on Docker PlatformPrimary DI number should be M722XD20104C20037 ClearRead Detect on Docker PlatformPrimary DI number should be M722XD20104C200370.Re-entered 12/30/2020. | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
11 | M722XD20104C200370 | 1.1.0 | ClearRead Detect on Docker PlatformPrimary DI number mistyped as M722XD20104C203 ClearRead Detect on Docker PlatformPrimary DI number mistyped as M722XD20104C20370.Originally entered on 5/19/2020. | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
12 | M722XD20104B20370 | 3.6.2 | ClearRead Bone Suppress on Docker Platform.Primary DI Number should be M722XD201 ClearRead Bone Suppress on Docker Platform.Primary DI Number should be M722XD20104B200370.Re-entered 12/30/2020. | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
13 | M722XD20104B200370 | 1.1.0 | ClearRead Bone Suppress on Docker Platform.Primary DI Number mistyped as M722XD2 ClearRead Bone Suppress on Docker Platform.Primary DI Number mistyped as M722XD20104B20370.Originally entered on 5/19/2020 | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
14 | M722X21224E212210 | 3.0.0 | ClearRead Enhance on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Enhance Server | |
15 | M722X21165E211640 | 3.0.0 | ClearRead Enhance on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Enhance Server | |
16 | M722X21165C211640 | 6.1.0 | ClearRead Detect on Server | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Server | |
17 | M722X20320C203200 | 6.0.0 | ClearRead Xray +Detect on Connect Platform | MYN | Analyzer,Medical Image | 2 | ClearRead Xray +Detect | |
18 | M722R11266T00211 | 2.1 | Deltaview on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | Deltaview | |
19 | M722R11266C00521 | 5.2.1 | OnGuard on RCP Platform | MYN | Analyzer,Medical Image | 2 | OnGuard | |
20 | M722XD21165C211640 | 6.1.0 | ClearRead Detect Docker | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
21 | M722XD21165B211640 | 4.0.0 | ClearRead Bone Suppress Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
22 | M722XD21012C203200 | 3.0.0 | ClearRead Detect on Docker Platform | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
23 | M722X21224C212210 | 6.1.0 | ClearRead Detect on Server | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Server | |
24 | M722XC22145B212210 | 4.0.0 | ClearRead Bone Suppress on Console Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Bone Suppress | |
25 | M722XC21224L212210 | 3.0.0 | ClearRead Confirm Console | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Console | |
26 | M722XC21224C212210 | 6.1.0 | ClearRead Detect Console | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Console | |
27 | M722XC21165L211640 | 3.0.0 | ClearRead Confirm Console | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Console | |
28 | M722XC21165C211640 | 6.1.0 | ClearRead Detect Console | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Console | |
29 | M722X22145B212210 | 4.0.0 | ClearRead Bone Suppress on Server Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Bone Suppress | |
30 | M722X21224B212210 | 4.0.0 | ClearRead Bone Suppress on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Server | |
31 | M722X21165B211640 | 4.0.0 | ClearRead Bone Suppress on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Server | |
32 | M722X20320T203200 | 4.0.0 | ClearRead Xray +Compare on Connect Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray +Compare | |
33 | M722C22112V213240 | 5.5.0 | ClearRead CT Server | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Server | |
34 | M722C21343V213240 | 5.2.0 | ClearRead CT Server | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Server | |
35 | M722C21133V211240 | 5.0.0 | ClearRead CT Server | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Server | |
36 | M722C14295L142720 | 2.0 | ClearRead +Confirm on Connect Platform | LLZ | System, Image Processing, Radiological | 2 | Clear Read +Confirm | |
37 | M722XD22145B212210 | 4.0.0 | ClearRead Bone Suppress on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Bone Suppress | |
38 | M722XD21165L211640 | 3.0.0 | ClearRead Confirm Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
39 | M722Z19154V191210 | 1.0.2 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console | |
40 | M722XD20239L200370 | 1.2.0 | ClearRead Confirm on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
41 | M722XD20104L20370 | 2.2.1 | ClearRead Confirm on Docker PlatformPrimary DI Number should be M722XD20104L2003 ClearRead Confirm on Docker PlatformPrimary DI Number should be M722XD20104L200370.Re-entered on 12/30/2020. | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
42 | M722XD20104L200370 | 1.1.0 | ClearRead Confirm on Docker PlatformOriginally mistyped as M722XD20104L20370.Ori ClearRead Confirm on Docker PlatformOriginally mistyped as M722XD20104L20370.Originally entered on 5/19/2020. | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
43 | M722X21224T212210 | 4.0.0 | ClearRead Compare on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Compare Server | |
44 | M722X21165T211640 | 4.0.0 | ClearRead Compare on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Compare Server | |
45 | M722R14273T142720 | 3.1 | ClearRead +Compare on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead +Compare | |
46 | M722R14164T140290 | 3.1 | ClearRead +Compare on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead +Compare | |
47 | M722R14042T140290 | 3.1 | ClearRead +Compare on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead +Compare | |
48 | M722CC22110V213240 | 5.5.0 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console | |
49 | M722CC21343V213240 | 5.2.0 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console | |
50 | M722CC21133V211240 | 5.0.0 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | M722XD22145C212210 | 6.1.0 | ClearRead Detect on Docker Platform | ClearRead Xray Detect | RIVERAIN TECHNOLOGIES, INC. | |
2 | M722XD21224C212210 | 6.1.0 | ClearRead Detect Docker | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
3 | M722XD21165C211640 | 6.1.0 | ClearRead Detect Docker | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
4 | M722XD21012C203200 | 3.0.0 | ClearRead Detect on Docker Platform | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
5 | M722XD20239C200370 | 1.2.0 | ClearRead Detect on Docker Platform | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
6 | M722XD20104C20370 | 5.3.1 | ClearRead Detect on Docker PlatformPrimary DI number should be M722XD20104C20037 ClearRead Detect on Docker PlatformPrimary DI number should be M722XD20104C200370.Re-entered 12/30/2020. | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
7 | M722XD20104C200370 | 1.1.0 | ClearRead Detect on Docker PlatformPrimary DI number mistyped as M722XD20104C203 ClearRead Detect on Docker PlatformPrimary DI number mistyped as M722XD20104C20370.Originally entered on 5/19/2020. | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
8 | M722XC22145C212210 | 6.1.0 | ClearRead Detect on Console Platform | ClearRead Xray Detect | RIVERAIN TECHNOLOGIES, INC. | |
9 | M722XC21224C212210 | 6.1.0 | ClearRead Detect Console | ClearRead Detect Console | RIVERAIN TECHNOLOGIES, INC. | |
10 | M722XC21165C211640 | 6.1.0 | ClearRead Detect Console | ClearRead Detect Console | RIVERAIN TECHNOLOGIES, INC. | |
11 | M722X22145C212210 | 6.1.0 | ClearRead Detect on Server Platform | ClearRead Xray Detect | RIVERAIN TECHNOLOGIES, INC. | |
12 | M722X21224C212210 | 6.1.0 | ClearRead Detect on Server | ClearRead Detect Server | RIVERAIN TECHNOLOGIES, INC. | |
13 | M722X21165C211640 | 6.1.0 | ClearRead Detect on Server | ClearRead Detect Server | RIVERAIN TECHNOLOGIES, INC. | |
14 | M722X20320C203200 | 6.0.0 | ClearRead Xray +Detect on Connect Platform | ClearRead Xray +Detect | RIVERAIN TECHNOLOGIES, INC. | |
15 | M722R15264C152610 | 5.2.3 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
16 | M722R14273C142720 | 5.2.3 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
17 | M722R14164C140290 | 5.2.2 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
18 | M722R14042C140290 | 5.2.2 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
19 | M722R11266C00521 | 5.2.1 | OnGuard on RCP Platform | OnGuard | RIVERAIN TECHNOLOGIES, INC. | |
20 | M722C19129C190710 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
21 | M722C19091C190710 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
22 | M722C18334C180560 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
23 | M722C18058C180560 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
24 | M722C17018C170170 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
25 | M722C16274C162640 | 5.3.0 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
26 | M722C16273C162630 | 5.3.0 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
27 | M722C16132C161250 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
28 | M722C16033C160130 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
29 | M722C16022C160130 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
30 | M722C15264C152610 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
31 | M722C15169C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
32 | M722C15068C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
33 | M722C15056C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
34 | M722C15031C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
35 | M722C14295C142720 | 5.2.3 | ClearRead +Detect on Connect Platform | Clear Read +Detect | RIVERAIN TECHNOLOGIES, INC. | |
36 | M722C14274C142720 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
37 | M722C14252C142260 | 5.2.2 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
38 | 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 | |
39 | 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 | |
40 | 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 | |
41 | 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. |
42 | 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. |
43 | 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. |
44 | 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. |
45 | 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. |
46 | 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. |
47 | 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. |
48 | 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. |
49 | 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. |
50 | 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. |