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 | 04897117800007 | AccuBrain_Intl | AccuBrain | BRAINNOW MEDICAL TECHNOLOGY LIMITED | ||
2 | 04779049590105 | 7.5.1 | NA | MedDream is a software medical imaging system used to receive DICOM images, sche MedDream is a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. Software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians, clinicians.Contraindications: The MedDream is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose medical image data. | MedDream | SOFTNETA UAB |
3 | 04719875623103 | 1.0 | UO-0102 | AmCAD UO is a PC based, self contained, non invasive image analysis software app AmCAD UO is a PC based, self contained, non invasive image analysis software application for reviewing the pharyngeal/upper airway ultrasonic image acquired from an FDA cleared ultrasound system. The software is designed to support visualization and quantification of the airway sonographic characteristics. The software also provides tools for manual or interactive selection of Region of Interest to allow for analysis of the airway in terms of its size, position and enhancement pattern. This analysis provides information for physician’s evaluation and monitoring of the airway state. | AmCAD UO | AMCAD BIOMED CORPORATION |
4 | 04719875621130 | 2.2 | UT-0222-1Q | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
5 | 04719875621123 | 2.2 | UT-0222-1P | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
6 | 04719875621116 | 2.2 | UT-0222-KOL | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
7 | 04719875621109 | 2.2 | UT-0222-50 | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
8 | 04719875621093 | 2.2 | UT-0222-1000 | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
9 | 04719875621086 | 2.2 | UT-0222-1Y | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
10 | 04719875621024 | 2.2 | UT-0222-500 | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
11 | 04719875621017 | 2.2 | UT-0222-D | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
12 | 04719875621000 | 2.2 | UT-0222 | AmCAD UT Detection is a Windows computer aided detection device intended to assi AmCAD UT Detection is a Windows computer aided detection device intended to assist the medical professionals in analyzing thyroid ultrasound images, acquired from FDA cleared ultrasound systems, with user selected regions of interest. After the initial review of the ultrasound images by the physicians, the device further provides detailed information with quantification and visualization of sonographic characteristics of thyroid nodules. The device is intended for use on ultrasound images of discrete thyroid nodules larger than 1cm, for which a biopsy recommendation is required. | AmCAD UT Detection | AMCAD BIOMED CORPORATION |
13 | 04573596213759 | DAS-RS1 | ULTRASOUND DATA ANALYSIS SYSTEM | DAS-RS1 | FUJIFILM HEALTHCARE CORPORATION | |
14 | 04571320222008 | Ziostation2 | Ziostation2 is a basic DICOM image management system to further aid clinicians i Ziostation2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging toolsand techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound,Digital X-ray X-ray Angiography, PET, SPECT, NM, SC, Mammography, X-ray Radiofluoroscopic image, RTImage. | Ziostation2 | ZIOSOFT, INC. | |
15 | 04562122958639 | DAS-RS1 | ULTRASOUND DATA ANALYSIS SYSTEM | HITACHI | HITACHI, LTD. | |
16 | 04560141950382 | V1.94R00E | ImagePilot | KONICA MINOLTA, INC. | ||
17 | 04560141949584 | V1.93R00E | ImagePilot | KONICA MINOLTA, INC. | ||
18 | 04560141949492 | V1.92R00E | ImagePilot | KONICA MINOLTA, INC. | ||
19 | 04560141947788 | ACDY | KONICAMINOLTA DI-X1 | KONICA MINOLTA, INC. | ||
20 | 04560141947771 | ACDX | KONICAMINOLTA DI-X1 | KONICA MINOLTA, INC. | ||
21 | 04560141945166 | A4C1 | CS-7 | KONICA MINOLTA, INC. | ||
22 | 04560141944961 | D9MA | ImagePilot | KONICA MINOLTA, INC. | ||
23 | 04548213030804 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
24 | 04548213026982 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
25 | 04548213026975 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
26 | 04548213026968 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
27 | 04548213026951 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
28 | 04548213026944 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
29 | 04548213026852 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
30 | 04548213026845 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
31 | 04548213026838 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
32 | 04548213026821 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
33 | 04548213026814 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
34 | 04548213026807 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
35 | 04548213026791 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
36 | 04548213026784 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
37 | 04548213026777 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
38 | 04548213026760 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
39 | 04548213025299 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
40 | 04548213025282 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
41 | 04548213025183 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
42 | 04548213025176 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
43 | 04548213024735 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
44 | 04548213024728 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
45 | 04548213024711 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
46 | 04548213024704 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
47 | 04548213024698 | i-Dixel | i-Dixel | J.MORITA MFG.CORP. | ||
48 | 04547410345438 | MIS-1000 | ASPIRE Bellus II is medical imaging software that is intended to provide trained ASPIRE Bellus II is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting. This product accepts DICOM compliant medical images acquired from a variety of imaging devices including, MG, CT, PT, MR, CR, DX, and US, etc. This product also provides general 2D/3D viewing and general image processing, measurements, annotations, reporting, printing, storing, and general image administration tools, etc. | ASPIRE Bellus II | FUJIFILM CORPORATION | |
49 | 04547410333527 | DR-ID800CL | The Console is a workstation intended to associate digital (for DR) images with The Console is a workstation intended to associate digital (for DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. | DR-ID800CL | FUJIFILM CORPORATION | |
50 | 04547410324877 | Synapse 3D | The product “Synapse 3D Base Tools” is a system that receives and retrieves DICO The product “Synapse 3D Base Tools” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis. | Synapse 3D | FUJIFILM CORPORATION |