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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
Focal Healthcare Inc
2.0
In Commercial Distribution

  • 00628055858010 ()


  • Radiology picture archiving and communication system workstation
Fusion Bx 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. The device will assist clinicians in planning and performing image-guided interventional procedures such as biopsies and placing instruments in the prostate for adult men with suspected prostate cancer. Fusion Bx is comprised of a laptop-based workstation and a hardware assembly. The included hardware consists of a frame grabber, encoder converter, hardware arm (comprising of a swing arm, counterbalance, tracker and stepper), and stand. The stepper holds the ultrasound probe and measures probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. Encoders in the stepper and tracker send joint movement information to the computer workstation which tracks probe position and orientation. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Fusion Bx. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate and to display the live image position within the prostate.
Focal Healthcare Inc
1.1
In Commercial Distribution

  • 00628055858003 ()


  • Radiology picture archiving and communication system workstation
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.
FUJIFILM CORPORATION
MIS-1000
In Commercial Distribution

  • 04547410345438 ()


  • Radiology picture archiving and communication system workstation
The product “Synapse 3D” 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.
FUJIFILM CORPORATION
Synapse 3D
In Commercial Distribution

  • 04547410324877 ()


  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDCC-6430
In Commercial Distribution

  • 05415334000513 ()
K9301635B

  • Radiology picture archiving and communication system workstation
MDNC-2123 DE WH
Barco NV
MDNC-2123
In Commercial Distribution

  • 05415334000384 ()
K9300330A

  • Radiology picture archiving and communication system workstation
MDNC-2123 EM BL
Barco NV
MDNC-2123
Not in Commercial Distribution

  • 05415334000377 ()
K9300332A

  • Radiology picture archiving and communication system workstation
MDNG-3220 W/O FF CN
Barco NV
MDNG-3220
In Commercial Distribution

  • 05415334000360 ()
K9301863A

  • Radiology picture archiving and communication system workstation
MDNG-3220 CN
Barco NV
MDNG-3220
In Commercial Distribution

  • 05415334000353 ()
K9301862A

  • Radiology picture archiving and communication system workstation
MDNG-3220 W/O FF
Barco NV
MDNG-3220
Not in Commercial Distribution

  • 05415334000346 ()
K9301861A

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDNG-3220
In Commercial Distribution

  • 05415334000339 ()
K9301860A

  • Radiology picture archiving and communication system workstation
MDNC-2221 HE MK II
Barco NV
MDNC-2221
Not in Commercial Distribution

  • 05415334000322 ()
K9301653B

  • Radiology picture archiving and communication system workstation
MDNC-2221 HE
Barco NV
MDNC-2221
Not in Commercial Distribution

  • 05415334000315 ()
K9301653A

  • Radiology picture archiving and communication system workstation
MDNC-2221 W/O FF MKII
Barco NV
MDNC-2221
In Commercial Distribution

  • 05415334000308 ()
K9301649B

  • Radiology picture archiving and communication system workstation
MDNC-2221 W/O FF
Barco NV
MDNC-2221
Not in Commercial Distribution

  • 05415334000292 ()
K9301649A

  • Radiology picture archiving and communication system workstation
MDNC-3321 LE
Barco NV
MDNC-3321
Not in Commercial Distribution

  • 05415334000049 ()
K9300325A

  • Radiology picture archiving and communication system workstation
MDNC-3321 W/O FF
Barco NV
MDNC-3321
Not in Commercial Distribution

  • 05415334000032 ()
K9300324A

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDNC-3321
Not in Commercial Distribution

  • 05415334000025 ()
K9300323A

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDMC-12133
In Commercial Distribution

  • 05415334000018 ()
K9301680A

  • Radiology picture archiving and communication system workstation
MDNC-2221 MKII
Barco NV
MDNC-2221
In Commercial Distribution

  • 05415334000285 ()
K9301648B

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDNC-2221
Not in Commercial Distribution

  • 05415334000278 ()
K9301648A

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDCC-6430
In Commercial Distribution

  • 05415334000261 ()
K9301635A

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDCC-6330
Not in Commercial Distribution

  • 05415334000254 ()
K9301634A

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDCC-4330
In Commercial Distribution

  • 05415334000247 ()
K9301625A

  • Radiology picture archiving and communication system workstation
No Description
Barco NV
MDCC-4230
Not in Commercial Distribution

  • 05415334000230 ()
K9301615A

  • Radiology picture archiving and communication system workstation
MDCG-5221 BB GE
Barco NV
MDCG-5221
In Commercial Distribution

  • 05415334000223 ()
K9301542B

  • Radiology picture archiving and communication system workstation
MDCG-5221 BB GE
Barco NV
MDCG-5221
In Commercial Distribution

  • 05415334000216 ()
K9301542A

  • Radiology picture archiving and communication system workstation
MDCG-5221 BB
Barco NV
MDCG-5221
In Commercial Distribution

  • 05415334000209 ()
K9301541B

  • Radiology picture archiving and communication system workstation
MDCG-5221 BB
Barco NV
MDCG-5221
Not in Commercial Distribution

  • 05415334000193 ()
K9301541A

  • Radiology picture archiving and communication system workstation
MDCG-5221 CB
Barco NV
MDCG-5221
In Commercial Distribution

  • 05415334000186 ()
K9301540B

  • Radiology picture archiving and communication system workstation
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