Other products from "FOCAL HEALTHCARE INC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00628055858010 2.0 Fusion Bx 2.0 is designed to display the 2D live video received from commerciall Fusion Bx 2.0 is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians’ existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. Fusion Bx 2.0 offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe-based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure. LLZ System, Image Processing, Radiological 2 Fusion Bx
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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.
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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.
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50 M722X21224E212210 3.0.0 ClearRead Enhance on Server ClearRead Enhance Server RIVERAIN TECHNOLOGIES, INC.