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 | 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 | |
2 | 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 | |
3 | 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 | |
4 | B630QVCS343 | 3.4.3 | QVCAD System | QVIEW MEDICAL | ||
5 | B630QVCS342 | 3.4.2 | QVCAD System | QVIEW MEDICAL | ||
6 | B630QVCS34 | 3.4 | QVCAD System | QVIEW MEDICAL | ||
7 | B630QVCS33 | 3.3 | QVCAD System | QVIEW MEDICAL | ||
8 | 60889978008698 | Logicon Caries Detector | 8008690 | LOGICON SITE LIC (UP TO 10) W/IWT | Logicon Caries Detector | CARESTREAM HEALTH, INC. |
9 | 60192156851628 | Logicon Caries Detector | 8008690 | LOGICON SITE LIC (UP TO 10) W/IWT | Logicon Caries Detector | CARESTREAM DENTAL LLC |
10 | 60192155942754 | Logicon Caries Detector | 5942750 | CSD LOGICON CARIES DETECTOR | Logicon Caries Detector | CARESTREAM DENTAL LLC |
11 | M994MVU10500 | 1050 | The M-Vu Algorithm Engine is a Computer-Aided Detection (CAD) software device in The M-Vu Algorithm Engine is a Computer-Aided Detection (CAD) software device intended to aid radiologists in reading mammograms. It is a proprietary software application designed to process digitized film mammograms and digital mammograms. The mammogram images are automatically analyzed to mark areas for review by a radiologist. Results are displayed on either a mammography workstation, high resolution monitor, or printed case report. | M-Vu Algorithm Engine | VUCOMP, INC. | |
12 | M760ACCFFDM00170 | 7.0 | ACCFFDM00170 | Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device inte Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®. | Parascript® AccuDetect® | PARASCRIPT, LLC |
13 | M760ACCFFDM00161 | 6.1 | ACCFFDM00161 | Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device inte Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®. | Parascript® AccuDetect® | PARASCRIPT, LLC |
14 | 15420045500037 | 10.0 | R2LIC-2111 | ImageChecker CAD 10.0 | HOLOGIC, INC. | |
15 | M722XD22145C212210 | 6.1.0 | ClearRead Detect on Docker Platform | ClearRead Xray Detect | RIVERAIN TECHNOLOGIES, INC. | |
16 | M722XD21224C212210 | 6.1.0 | ClearRead Detect Docker | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
17 | M722XD21165C211640 | 6.1.0 | ClearRead Detect Docker | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
18 | M722XD21012C203200 | 3.0.0 | ClearRead Detect on Docker Platform | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
19 | M722XD20239C200370 | 1.2.0 | ClearRead Detect on Docker Platform | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
20 | 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. | |
21 | 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. | |
22 | M722XC22145C212210 | 6.1.0 | ClearRead Detect on Console Platform | ClearRead Xray Detect | RIVERAIN TECHNOLOGIES, INC. | |
23 | M722XC21224C212210 | 6.1.0 | ClearRead Detect Console | ClearRead Detect Console | RIVERAIN TECHNOLOGIES, INC. | |
24 | M722XC21165C211640 | 6.1.0 | ClearRead Detect Console | ClearRead Detect Console | RIVERAIN TECHNOLOGIES, INC. | |
25 | M722X22145C212210 | 6.1.0 | ClearRead Detect on Server Platform | ClearRead Xray Detect | RIVERAIN TECHNOLOGIES, INC. | |
26 | M722X21224C212210 | 6.1.0 | ClearRead Detect on Server | ClearRead Detect Server | RIVERAIN TECHNOLOGIES, INC. | |
27 | M722X21165C211640 | 6.1.0 | ClearRead Detect on Server | ClearRead Detect Server | RIVERAIN TECHNOLOGIES, INC. | |
28 | M722X20320C203200 | 6.0.0 | ClearRead Xray +Detect on Connect Platform | ClearRead Xray +Detect | RIVERAIN TECHNOLOGIES, INC. | |
29 | M722R15264C152610 | 5.2.3 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
30 | M722R14273C142720 | 5.2.3 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
31 | M722R14164C140290 | 5.2.2 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
32 | M722R14042C140290 | 5.2.2 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
33 | M722R11266C00521 | 5.2.1 | OnGuard on RCP Platform | OnGuard | RIVERAIN TECHNOLOGIES, INC. | |
34 | M722C19129C190710 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
35 | M722C19091C190710 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
36 | M722C18334C180560 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
37 | M722C18058C180560 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
38 | M722C17018C170170 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
39 | M722C16274C162640 | 5.3.0 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
40 | M722C16273C162630 | 5.3.0 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
41 | M722C16132C161250 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
42 | M722C16033C160130 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
43 | M722C16022C160130 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
44 | M722C15264C152610 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
45 | M722C15169C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
46 | M722C15068C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
47 | M722C15056C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
48 | M722C15031C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
49 | M722C14295C142720 | 5.2.3 | ClearRead +Detect on Connect Platform | Clear Read +Detect | RIVERAIN TECHNOLOGIES, INC. | |
50 | M722C14274C142720 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. |