| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00850631008179 | 3.9.1 | Roentgen Works 3.9.1 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 2 | 00850631008384 | 5.0.2 | Roentgen Works 5.0.2 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 3 | 00850631008377 | 5.0.1 | Roentgen Works 5.0.1 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 4 | 00850631008513 | 5.4.0 | Roentgen Works 5.4.0 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 5 | 00850631008483 | 5.3.0 | Roentgen Works 5.3.0 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 6 | 00850631008476 | 5.2.1 | Roentgen Works 5.2.1 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 7 | 00850631008469 | 5.2.0 | Roentgen Works 5.2.0 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 8 | 00850631008452 | 5.1.3 | Roentgen Works 5.1.3 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 9 | 00850631008445 | 5.1.2 | Roentgen Works 5.1.2 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 10 | 00850631008438 | 5.1.1 | Roentgen Works 5.1.1 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 11 | 00850631008421 | 5.1.0 | Roentgen Works 5.1.0 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 12 | 00850631008414 | 5.0.5 | Roentgen Works 5.0.5 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 13 | 00850631008407 | 5.0.4 | Roentgen Works 5.0.4 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 14 | 00850631008391 | 5.0.3 | Roentgen Works 5.0.3 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 15 | 00850631008346 | 5.0.0 | Roentgen Works 5.0.0 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 16 | 00850631008339 | 4.3.2 | Roentgen Works 4.3.2 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 17 | 00850631008322 | 4.3.1 | Roentgen Works 4.3.1 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 18 | 00850631008315 | 4.3.0 | Roentgen Works 4.3.0 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 19 | 00850631008308 | 4.2.3 | Roentgen Works 4.2.3 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 20 | 00850631008292 | 4.2.2 | Roentgen Works 4.2.2 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 21 | 00850631008285 | 4.2.1 | Roentgen Works 4.2.1 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 22 | 00850631008278 | 4.2.0 | Roentgen Works 4.2.0 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 23 | 00850631008261 | 4.1.3 | Roentgen Works 4.1.3 is a PACS, RIS, and Viewer. | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 24 | 00850631008254 | 4.1.2 | Roentgen Works 4.1.2 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 25 | 00850631008247 | 4.1.1 | Roentgen Works 4.1.1 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 26 | 00850631008230 | 4.1.0 | Roentgen Works 4.1.0 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 27 | 00850631008223 | 4.0.0 | Roentgen Works 4.0.0 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 28 | 00850631008216 | 3.9.5 | Roentgen Works 3.9.5 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 29 | 00850631008209 | 3.9.4 | Roentgen Works 3.9.4 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 30 | 00850631008193 | 3.9.3 | Roentgen Works 3.9.3 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 31 | 00850631008186 | 3.9.2 | Roentgen Works 3.9.2 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 32 | 00850631008162 | 3.9.0 | Roentgen Works 3.9.0 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 33 | 00850631008148 | 3.8.3 | Roentgen Works 3.8.3 | LLZ,LMB | System, Image Processing, Radiological,Device, Digital Image Storage, Radiological | 1 | Roentgen Works | |
| 34 | 00850631008131 | 3.8.2 | Roentgen Works 3.8.2 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 35 | 00850631008124 | 3.8.1 | Roentgen Works 3.8.1 | LLZ,LMB | System, Image Processing, Radiological,Device, Digital Image Storage, Radiological | 1 | Roentgen Works | |
| 36 | 00850631008117 | 3.8.0 | Roentgen Works 3.8.0 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 37 | 00850631008063 | 3.7.3 | Roentgen Works 3.7.3 | LLZ,LMB | System, Image Processing, Radiological,Device, Digital Image Storage, Radiological | 1 | Roentgen Works | |
| 38 | 00850631008032 | 3.7.2 | Roentgen Works 3.7.2 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 39 | 00850631008025 | 3.7.1 | Roentgen Works 3.7.1 | LLZ,LMB | System, Image Processing, Radiological,Device, Digital Image Storage, Radiological | 1 | Roentgen Works | |
| 40 | 00850631008018 | 3.7.0 | Roentgen Works 3.7.0 | LLZ,LMB | System, Image Processing, Radiological,Device, Digital Image Storage, Radiological | 1 | Roentgen Works | |
| 41 | 00850631008001 | 3.6.0 | Roentgen Works 3.6.0 | LMB,LLZ | Device, Digital Image Storage, Radiological,System, Image Processing, Radiological | 1 | Roentgen Works | |
| 42 | 00850631008490 | 4.1.1 | BRIT Vision 4.1.1 | LLZ | System, Image Processing, Radiological | 2 | BRIT Vision | |
| 43 | 00850631008070 | 4.1.0 | BRIT Vision 4.1.0 | LLZ | System, Image Processing, Radiological | 2 | BRIT Vision | |
| 44 | 00850631008087 | 4.1.0 | Roentgen Files 4.1.0 | LMB | Device, Digital Image Storage, Radiological | 1 | Roentgen Files | |
| 45 | 00850631008506 | 4.1.1 | Roentgen Files 4.1.1 | LMB | Device, Digital Image Storage, Radiological | 1 | Roentgen Files | |
| 46 | 00850631008100 | 3.4.1.0 | BRIT Lite 3.4.1.0 | LLZ | System, Image Processing, Radiological | 2 | BRIT Lite | |
| 47 | 00850631008360 | 3.4.2 | BRIT Lite 3.4.2 is an easy to use application for viewing DICOM images from a CD BRIT Lite 3.4.2 is an easy to use application for viewing DICOM images from a CD/DVD. In addition, it can be installed as a desktop application to view DICOM images from Roentgen Files (BRIT PACS). | LLZ | System, Image Processing, Radiological | 2 | BRIT Lite | |
| 48 | 00850631008056 | 3.4.0.0 | BRIT Lite 3.4.0.0 | LLZ | System, Image Processing, Radiological | 2 | BRIT Lite | |
| 49 | 00850631008094 | 2.4.1.0 | Pacs View 2.4.1.0 | LLZ | System, Image Processing, Radiological | 2 | Pacs View | |
| 50 | 00850631008353 | 2.4.2.0 | Pacs View 2.4.2.0 is a Windows DICOM image viewer. | LLZ | System, Image Processing, Radiological | 2 | Pacs View |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 14573443600029 | Ver.14.0.4.1 | ZedView | LEXI CO., LTD. | ||
| 2 | 14260495880331 | 3.3.0 | The product mint Lesion helps qualified radiologists with the image-based diagno The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatment response assessment of oncological diseases. Fields of application are radiological diagnosis and follow-up examinations in oncology, as well as clinical or pharmaceutical drug trials across a defined group of patients. mint Lesion implements various radiological guidelines and response evaluation criteria, such as RECIST (Response Evaluation Criteria In Solid Tumors). This also includes the assessment of the stage of oncological disease (staging) and the objective response to therapy (e.g. timepoint response / overall response). The timepoint response is an empirical measure to evaluate therapy success according to the response criteria in use. It is mainly used to assess patient cohorts in the course of clinical trials of novel therapy agents. The timepoint response may differ from a radiological assessment of response to therapy and must not be used as a surrogate. mint Lesion allows for the documentation of size and assessment of changes in size of solid tumors described by the respective criteria that are monitored by means of radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine (PET, NM), digital radiography (XR, CR)). mint Lesion follows the typical workflow of follow-up examinations, from assessment to reporting, and enables the integration of a clinical-radiological software environment (PACS, Picture Archiving and Communication System). Assessment results can be exported into different electronical formats and processed further by other applications. | mintLesion® | MINT MEDICAL GMBH | |
| 3 | M722Z19154V191210 | 1.0.2 | ClearRead CT Console | ClearRead CT Console | RIVERAIN TECHNOLOGIES, INC. | |
| 4 | M722Z19122V191210 | 1.0.1.32 | ClearRead CT Console | ClearRead CT Console | RIVERAIN TECHNOLOGIES, INC. | |
| 5 | M722Z19077V190530 | 1.0.0.26 | ClearRead CT Console | ClearRead CT Console | RIVERAIN TECHNOLOGIES, INC. | |
| 6 | M722XD22145T212210 | 4.0.0 | ClearRead Compare on Docker Platform | ClearRead Xray Compare | RIVERAIN TECHNOLOGIES, INC. | |
| 7 | M722XD22145L212210 | 3.0.0 | ClearRead Confirm on Docker Platform | ClearRead Xray Confirm | RIVERAIN TECHNOLOGIES, INC. | |
| 8 | M722XD22145E212210 | 3.0.0 | ClearRead Enhance on Docker Platform | ClearRead Xray Enhance | RIVERAIN TECHNOLOGIES, INC. | |
| 9 | M722XD22145B212210 | 4.0.0 | ClearRead Bone Suppress on Docker Platform | ClearRead Xray Bone Suppress | RIVERAIN TECHNOLOGIES, INC. | |
| 10 | M722XD21224T212210 | 4.0.0 | ClearRead Compare Docker | ClearRead Compare Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 11 | M722XD21224L212210 | 3.0.0 | ClearRead Confirm Docker | ClearRead Confirm Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 12 | M722XD21224E212210 | 3.0.0 | ClearRead Enhance Docker | ClearRead Enhance Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 13 | M722XD21224B212210 | 4.0.0 | ClearRead Bone Suppress Docker | ClearRead Bone Suppress Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 14 | M722XD21165T211640 | 4.0.0 | ClearRead Compare Docker | ClearRead Compare Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 15 | M722XD21165L211640 | 3.0.0 | ClearRead Confirm Docker | ClearRead Confirm Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 16 | M722XD21165E211640 | 3.0.0 | ClearRead Enhance Docker | ClearRead Enhance Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 17 | M722XD21165B211640 | 4.0.0 | ClearRead Bone Suppress Docker | ClearRead Bone Suppress Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 18 | M722XD21012T203200 | 3.0.0 | ClearRead Compare on Docker Platform | ClearRead Compare Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 19 | M722XD21012L203200 | 3.0.0 | ClearRead Confirm on Docker Platform | ClearRead Confirm Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 20 | M722XD21012E203200 | 3.0.0 | ClearRead Enhanced on Docker Platform | ClearRead Enhanced Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 21 | M722XD21012B203200 | 3.0.0 | ClearRead Bone Suppress on Docker Platform | ClearRead Bone Suppress Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 22 | M722XD20239T200370 | 1.2.0 | ClearRead Compare on Docker Platform | ClearRead Compare Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 23 | M722XD20239L200370 | 1.2.0 | ClearRead Confirm on Docker Platform | ClearRead Confirm Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 24 | M722XD20239E200370 | 1.2.0 | ClearRead Enhanced on Docker Platform | ClearRead Enhanced Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 25 | M722XD20239B200370 | 1.2.0 | ClearRead Bone Suppress on Docker Platform | ClearRead Bone Suppress Docker | RIVERAIN TECHNOLOGIES, INC. | |
| 26 | 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. | |
| 27 | 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. | |
| 28 | 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. | |
| 29 | 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. | |
| 30 | 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. | |
| 31 | 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. | |
| 32 | 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. | |
| 33 | 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. | |
| 34 | M722XC22145T212210 | 4.0.0 | ClearRead Compare on Console Platform | ClearRead Xray Compare | RIVERAIN TECHNOLOGIES, INC. | |
| 35 | M722XC22145L212210 | 3.0.0 | ClearRead Confirm on Console Platform | ClearRead Xray Confirm | RIVERAIN TECHNOLOGIES, INC. | |
| 36 | M722XC22145E212210 | 3.0.0 | ClearRead Enhance on Console Platform | ClearRead Xray Enhance | RIVERAIN TECHNOLOGIES, INC. | |
| 37 | M722XC22145B212210 | 4.0.0 | ClearRead Bone Suppress on Console Platform | ClearRead Xray Bone Suppress | RIVERAIN TECHNOLOGIES, INC. | |
| 38 | M722XC21224T212210 | 4.0.0 | ClearRead Compare Console | ClearRead Compare Console | RIVERAIN TECHNOLOGIES, INC. | |
| 39 | M722XC21224L212210 | 3.0.0 | ClearRead Confirm Console | ClearRead Confirm Console | RIVERAIN TECHNOLOGIES, INC. | |
| 40 | M722XC21224E212210 | 3.0.0 | ClearRead Enhance Console | ClearRead Enhance Console | RIVERAIN TECHNOLOGIES, INC. | |
| 41 | M722XC21224B212210 | 4.0.0 | ClearRead Bone Suppress Console | ClearRead Bone Suppress Console | RIVERAIN TECHNOLOGIES, INC. | |
| 42 | M722XC21165T211640 | 4.0.0 | ClearRead Compare Console | ClearRead Compare Console | RIVERAIN TECHNOLOGIES, INC. | |
| 43 | M722XC21165L211640 | 3.0.0 | ClearRead Confirm Console | ClearRead Confirm Console | RIVERAIN TECHNOLOGIES, INC. | |
| 44 | M722XC21165E211640 | 3.0.0 | ClearRead Enhance Console | ClearRead Enhance Console | RIVERAIN TECHNOLOGIES, INC. | |
| 45 | M722XC21165B211640 | 4.0.0 | ClearRead Bone Suppress Console | ClearRead Bone Suppress Console | RIVERAIN TECHNOLOGIES, INC. | |
| 46 | M722X22145T212210 | 4.0.0 | ClearRead Compare on Server Platform | ClearRead Xray Compare | RIVERAIN TECHNOLOGIES, INC. | |
| 47 | M722X22145L212210 | 3.0.0 | ClearRead Confirm on Server Platform | ClearRead Xray Confirm | RIVERAIN TECHNOLOGIES, INC. | |
| 48 | M722X22145E212210 | 3.0.0 | ClearRead Enhance on Server Platform | ClearRead Xray Enhance | RIVERAIN TECHNOLOGIES, INC. | |
| 49 | M722X22145B212210 | 4.0.0 | ClearRead Bone Suppress on Server Platform | ClearRead Xray Bone Suppress | RIVERAIN TECHNOLOGIES, INC. | |
| 50 | M722X21224T212210 | 4.0.0 | ClearRead Compare on Server | ClearRead Compare Server | RIVERAIN TECHNOLOGIES, INC. |