| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00864747000279 | 4.0.6 | suiteHEART® Software is intended to assist trained clinical personnel in the qua suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | LLZ | System, Image Processing, Radiological | 2 | suiteHEART | |
| 2 | 00864747000255 | 4.0.3 | suiteHEART® Software is intended to assist trained clinical personnel in the qua suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | LLZ | System, Image Processing, Radiological | 2 | suiteHEART | |
| 3 | 00864747000224 | 4.0.1 | suiteHEART® Software is intended to assist trained clinical personnel in the qua suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | LLZ | System, Image Processing, Radiological | 2 | suiteHEART | |
| 4 | 00864747000217 | 4.0.0 | suiteHEART® Software is intended to assist trained clinical personnel in the qua suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | LLZ | System, Image Processing, Radiological | 2 | suiteHEART | |
| 5 | 00864747000200 | 3.0.1 | suiteHEART® Software is intended to assist trained clinical personnel in the qua suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | LLZ | System, Image Processing, Radiological | 2 | suiteHEART | |
| 6 | 00850001088015 | 5 | suiteHEART Software is intended to assist trained clinical personnel in the qual suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | LLZ | System, Image Processing, Radiological | 2 | suiteHEART | |
| 7 | 00850001088008 | 4.0.7 | suiteHEART Software is intended to assist trained clinical personnel in the qual suiteHEART Software is intended to assist trained clinical personnel in the qualification and quantification of cardiac function. The software provides the tools to adjust the parameters of the DICOM images and provides presentation states where the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the software provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function. Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | LLZ | System, Image Processing, Radiological | 2 | suiteHEART | |
| 8 | 00864747000231 | 3.0.0 | NeoSoft’s CAKE product is a post-processing, productivity software package desig NeoSoft’s CAKE product is a post-processing, productivity software package designed to assist radiologists in the analysis of dynamic breast MR images. The software provides image display, supplemental information and visual enhancement of time/intensity changes extracted from MR temporal datasets. Single or multi-slice datasets, using standard acquisition protocols, are used for input.The results may be displayed as either a grayscale enhancement or a color overlay on the selected image. CAKE may perform additional functions to aid in the analysis and viewing of dynamic studies including registration of serial MR acquisitions, labeling of tissue types based upon user specified enhancement characteristics, visualization and quantification of lesion morphology in 3D, segmentation of tissues, multi-planar reformats, maximum intensity projections, image averaging, and subtractions.When interpreted by a skilled physician, this device provides information that may be useful in screening and diagnosis. Patient management decisions should not be made based solely on the results of CAKE analysis. | LLZ | System, Image Processing, Radiological | 2 | CAKE | |
| 9 | 00864747000248 | 4.0.2 | suiteHEART® Software is intended to assist trained clinical personnel in the qua suiteHEART® Software is intended to assist trained clinical personnel in the qualification and quantification of cardiacfunction. The software provides the tools to adjust the parameters of the DICOM images and provides presentation stateswhere the user can appreciate various MRI acquired images of the heart and vasculature over time. Additionally, the soft‐ware provides tools for measuring linear distances, areas, and volumes that can be used to quantify cardiac function.Finally, the software provides the tools for volumetric flow measurements and the ability to calculate flow values. | LLZ | System, Image Processing, Radiological | 2 | suiteHEART |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | M722Z19154V191210 | 1.0.2 | ClearRead CT Console | ClearRead CT Console | RIVERAIN TECHNOLOGIES, INC. | |
| 2 | M722Z19122V191210 | 1.0.1.32 | ClearRead CT Console | ClearRead CT Console | RIVERAIN TECHNOLOGIES, INC. | |
| 3 | M722Z19077V190530 | 1.0.0.26 | ClearRead CT Console | ClearRead CT Console | RIVERAIN TECHNOLOGIES, INC. | |
| 4 | M722XD22145T212210 | 4.0.0 | ClearRead Compare on Docker Platform | ClearRead Xray Compare | RIVERAIN TECHNOLOGIES, INC. | |
| 5 | M722XD22145L212210 | 3.0.0 | ClearRead Confirm on Docker Platform | ClearRead Xray Confirm | RIVERAIN TECHNOLOGIES, INC. | |
| 6 | M722XD22145E212210 | 3.0.0 | ClearRead Enhance on Docker Platform | ClearRead Xray Enhance | RIVERAIN TECHNOLOGIES, INC. | |
| 7 | M722XD22145B212210 | 4.0.0 | ClearRead Bone Suppress on Docker Platform | ClearRead Xray Bone Suppress | RIVERAIN TECHNOLOGIES, INC. | |
| 8 | M722XD21224T212210 | 4.0.0 | ClearRead Compare Docker | ClearRead Compare Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 9 | M722XD21224L212210 | 3.0.0 | ClearRead Confirm Docker | ClearRead Confirm Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 10 | M722XD21224E212210 | 3.0.0 | ClearRead Enhance Docker | ClearRead Enhance Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 11 | M722XD21224B212210 | 4.0.0 | ClearRead Bone Suppress Docker | ClearRead Bone Suppress Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 12 | M722XD21165T211640 | 4.0.0 | ClearRead Compare Docker | ClearRead Compare Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 13 | M722XD21165L211640 | 3.0.0 | ClearRead Confirm Docker | ClearRead Confirm Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 14 | M722XD21165E211640 | 3.0.0 | ClearRead Enhance Docker | ClearRead Enhance Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 15 | M722XD21165B211640 | 4.0.0 | ClearRead Bone Suppress Docker | ClearRead Bone Suppress Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 16 | M722XD21012T203200 | 3.0.0 | ClearRead Compare on Docker Platform | ClearRead Compare Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 17 | M722XD21012L203200 | 3.0.0 | ClearRead Confirm on Docker Platform | ClearRead Confirm Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 18 | M722XD21012E203200 | 3.0.0 | ClearRead Enhanced on Docker Platform | ClearRead Enhanced Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 19 | M722XD21012B203200 | 3.0.0 | ClearRead Bone Suppress on Docker Platform | ClearRead Bone Suppress Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 20 | M722XD20239T200370 | 1.2.0 | ClearRead Compare on Docker Platform | ClearRead Compare Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 21 | M722XD20239L200370 | 1.2.0 | ClearRead Confirm on Docker Platform | ClearRead Confirm Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 22 | M722XD20239E200370 | 1.2.0 | ClearRead Enhanced on Docker Platform | ClearRead Enhanced Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 23 | M722XD20239B200370 | 1.2.0 | ClearRead Bone Suppress on Docker Platform | ClearRead Bone Suppress Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 24 | M722XD20104T20370 | 3.3.1 | ClearRead Compare on Docker Platform.Primary DI Number should be M722XD20104T200 ClearRead Compare on Docker Platform.Primary DI Number should be M722XD20104T200370.Re-entered on 12/30/2020. | ClearRead Compare Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 25 | M722XD20104T200370 | 1.1.0 | ClearRead Compare on Docker Platform.Primary DI Number mistyped as M722XD20104T2 ClearRead Compare on Docker Platform.Primary DI Number mistyped as M722XD20104T20370.Originally entered on 5/19/2020. | ClearRead Compare Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 26 | 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. | ClearRead Confirm Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 27 | 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. | ClearRead Confirm Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 28 | M722XD20104E20370 | 2.2.1 | ClearRead Enhanced on Docker Platform.Primary DI Number should be M722XD20104E20 ClearRead Enhanced on Docker Platform.Primary DI Number should be M722XD20104E200370.Re-entered 12/30/2020. | ClearRead Enhanced Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 29 | M722XD20104E200370 | 1.1.0 | ClearRead Enhanced on Docker Platform.Primary DI Number mistype as M722XD20104E2 ClearRead Enhanced on Docker Platform.Primary DI Number mistype as M722XD20104E20370.Original submission date 5/19/2020. | ClearRead Enhanced Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 30 | 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. | ClearRead Bone Suppress Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 31 | 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 | ClearRead Bone Suppress Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 32 | M722XC22145T212210 | 4.0.0 | ClearRead Compare on Console Platform | ClearRead Xray Compare | RIVERAIN TECHNOLOGIES, INC. | |
| 33 | M722XC22145L212210 | 3.0.0 | ClearRead Confirm on Console Platform | ClearRead Xray Confirm | RIVERAIN TECHNOLOGIES, INC. | |
| 34 | M722XC22145E212210 | 3.0.0 | ClearRead Enhance on Console Platform | ClearRead Xray Enhance | RIVERAIN TECHNOLOGIES, INC. | |
| 35 | M722XC22145B212210 | 4.0.0 | ClearRead Bone Suppress on Console Platform | ClearRead Xray Bone Suppress | RIVERAIN TECHNOLOGIES, INC. | |
| 36 | M722XC21224T212210 | 4.0.0 | ClearRead Compare Console | ClearRead Compare Console | RIVERAIN TECHNOLOGIES, INC. | |
| 37 | M722XC21224L212210 | 3.0.0 | ClearRead Confirm Console | ClearRead Confirm Console | RIVERAIN TECHNOLOGIES, INC. | |
| 38 | M722XC21224E212210 | 3.0.0 | ClearRead Enhance Console | ClearRead Enhance Console | RIVERAIN TECHNOLOGIES, INC. | |
| 39 | M722XC21224B212210 | 4.0.0 | ClearRead Bone Suppress Console | ClearRead Bone Suppress Console | RIVERAIN TECHNOLOGIES, INC. | |
| 40 | M722XC21165T211640 | 4.0.0 | ClearRead Compare Console | ClearRead Compare Console | RIVERAIN TECHNOLOGIES, INC. | |
| 41 | M722XC21165L211640 | 3.0.0 | ClearRead Confirm Console | ClearRead Confirm Console | RIVERAIN TECHNOLOGIES, INC. | |
| 42 | M722XC21165E211640 | 3.0.0 | ClearRead Enhance Console | ClearRead Enhance Console | RIVERAIN TECHNOLOGIES, INC. | |
| 43 | M722XC21165B211640 | 4.0.0 | ClearRead Bone Suppress Console | ClearRead Bone Suppress Console | RIVERAIN TECHNOLOGIES, INC. | |
| 44 | M722X22145T212210 | 4.0.0 | ClearRead Compare on Server Platform | ClearRead Xray Compare | RIVERAIN TECHNOLOGIES, INC. | |
| 45 | M722X22145L212210 | 3.0.0 | ClearRead Confirm on Server Platform | ClearRead Xray Confirm | RIVERAIN TECHNOLOGIES, INC. | |
| 46 | M722X22145E212210 | 3.0.0 | ClearRead Enhance on Server Platform | ClearRead Xray Enhance | RIVERAIN TECHNOLOGIES, INC. | |
| 47 | M722X22145B212210 | 4.0.0 | ClearRead Bone Suppress on Server Platform | ClearRead Xray Bone Suppress | RIVERAIN TECHNOLOGIES, INC. | |
| 48 | M722X21224T212210 | 4.0.0 | ClearRead Compare on Server | ClearRead Compare Server | RIVERAIN TECHNOLOGIES, INC. | |
| 49 | M722X21224L212210 | 3.0.0 | ClearRead Confirm on Server | ClearRead Confirm Server | RIVERAIN TECHNOLOGIES, INC. | |
| 50 | M722X21224E212210 | 3.0.0 | ClearRead Enhance on Server | ClearRead Enhance Server | RIVERAIN TECHNOLOGIES, INC. |