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 | 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. | |
2 | 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 | |
3 | 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 | |
4 | 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 | |
5 | B630QVCS343 | 3.4.3 | QVCAD System | QVIEW MEDICAL | ||
6 | B630QVCS342 | 3.4.2 | QVCAD System | QVIEW MEDICAL | ||
7 | B630QVCS34 | 3.4 | QVCAD System | QVIEW MEDICAL | ||
8 | B630QVCS33 | 3.3 | QVCAD System | QVIEW MEDICAL | ||
9 | 60889978008698 | Logicon Caries Detector | 8008690 | LOGICON SITE LIC (UP TO 10) W/IWT | Logicon Caries Detector | CARESTREAM HEALTH, INC. |
10 | 60192156851628 | Logicon Caries Detector | 8008690 | LOGICON SITE LIC (UP TO 10) W/IWT | Logicon Caries Detector | CARESTREAM DENTAL LLC |
11 | 60192155942754 | Logicon Caries Detector | 5942750 | CSD LOGICON CARIES DETECTOR | Logicon Caries Detector | CARESTREAM DENTAL LLC |
12 | 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. | |
13 | 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 |
14 | 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 |
15 | 15420045500037 | 10.0 | R2LIC-2111 | ImageChecker CAD 10.0 | HOLOGIC, INC. | |
16 | M722XD22145C212210 | 6.1.0 | ClearRead Detect on Docker Platform | ClearRead Xray Detect | RIVERAIN TECHNOLOGIES, INC. | |
17 | M722XD21224C212210 | 6.1.0 | ClearRead Detect Docker | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
18 | M722XD21165C211640 | 6.1.0 | ClearRead Detect Docker | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
19 | M722XD21012C203200 | 3.0.0 | ClearRead Detect on Docker Platform | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
20 | M722XD20239C200370 | 1.2.0 | ClearRead Detect on Docker Platform | ClearRead Detect Docker | RIVERAIN TECHNOLOGIES, INC. | |
21 | 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. | |
22 | 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. | |
23 | M722XC22145C212210 | 6.1.0 | ClearRead Detect on Console Platform | ClearRead Xray Detect | RIVERAIN TECHNOLOGIES, INC. | |
24 | M722XC21224C212210 | 6.1.0 | ClearRead Detect Console | ClearRead Detect Console | RIVERAIN TECHNOLOGIES, INC. | |
25 | M722XC21165C211640 | 6.1.0 | ClearRead Detect Console | ClearRead Detect Console | RIVERAIN TECHNOLOGIES, INC. | |
26 | M722X22145C212210 | 6.1.0 | ClearRead Detect on Server Platform | ClearRead Xray Detect | RIVERAIN TECHNOLOGIES, INC. | |
27 | M722X21224C212210 | 6.1.0 | ClearRead Detect on Server | ClearRead Detect Server | RIVERAIN TECHNOLOGIES, INC. | |
28 | M722X21165C211640 | 6.1.0 | ClearRead Detect on Server | ClearRead Detect Server | RIVERAIN TECHNOLOGIES, INC. | |
29 | M722X20320C203200 | 6.0.0 | ClearRead Xray +Detect on Connect Platform | ClearRead Xray +Detect | RIVERAIN TECHNOLOGIES, INC. | |
30 | M722R15264C152610 | 5.2.3 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
31 | M722R14273C142720 | 5.2.3 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
32 | M722R14164C140290 | 5.2.2 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
33 | M722R14042C140290 | 5.2.2 | ClearRead +Detect on RCP Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
34 | M722R11266C00521 | 5.2.1 | OnGuard on RCP Platform | OnGuard | RIVERAIN TECHNOLOGIES, INC. | |
35 | M722C19129C190710 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
36 | M722C19091C190710 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
37 | M722C18334C180560 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
38 | M722C18058C180560 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
39 | M722C17018C170170 | 5.3.1 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
40 | M722C16274C162640 | 5.3.0 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
41 | M722C16273C162630 | 5.3.0 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
42 | M722C16132C161250 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
43 | M722C16033C160130 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
44 | M722C16022C160130 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
45 | M722C15264C152610 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
46 | M722C15169C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
47 | M722C15068C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
48 | M722C15056C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
49 | M722C15031C150280 | 5.2.3 | ClearRead +Detect on Connect Platform | ClearRead +Detect | RIVERAIN TECHNOLOGIES, INC. | |
50 | M722C14295C142720 | 5.2.3 | ClearRead +Detect on Connect Platform | Clear Read +Detect | RIVERAIN TECHNOLOGIES, INC. |