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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Accuray Precision™ Treatment Planning System (Version 3.0)
Accuray Incorporated
1063143
In Commercial Distribution

  • 00811376030092 ()
NA

  • Radiation therapy treatment planning workstation
110~240V~ 120kV
DRGEM Corporation
JADE-40
In Commercial Distribution

  • 08800011150099 ()


  • Mobile basic diagnostic x-ray system, analogue
100~240V~ 120kV
DRGEM Corporation
JADE-32
In Commercial Distribution

  • 08800011150082 ()


  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003293 ()
CB50

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003286 ()
CB40

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003279 ()
CB32

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-IV
In Commercial Distribution

  • 08436046003262 ()
CB20

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003095 ()
BA32

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003088 ()
BA20

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003071 ()
BA16

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003064 ()
AA32

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003057 ()
AA20

  • Mobile basic diagnostic x-ray system, analogue
Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography
SEDECAL
SM-V
In Commercial Distribution

  • 08436046003040 ()
AA16

  • Mobile basic diagnostic x-ray system, analogue
No Description
Voximetry, Inc.
V1.2
In Commercial Distribution

  • 00860010685402 ()


  • Nuclear medicine system workstation
The device is intended to estimate radiation absorbed dose (and related quantities) to tissues after administration of a radioactive product. For use with internally administered radioactive products, the device should not be used to deviate from product dosing and administration instructions. Refer to the product's prescribing information for instructions.
Radiopharmaceutical Imaging and Dosimetry, LLC
3DRD-001
In Commercial Distribution

  • 00860009926905 ()


  • Nuclear medicine system workstation
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
MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case-related non-image documents, archives them as DICOM data, and serves as a vendor-neutrall archive. It supports the physician in diagnosis. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. MedDream is a HTML based package for PACS server which is designed to aid professionals in every day's decision-making process, connecting all the medical data into a unified and fast performing network. MedDream ensures a fast and reliable way to search, present and analyze the medical data (images and video files) on various devices: computers, smart phones, tablets and so forth.
MEDDREAM UAB
7.5.1
In Commercial Distribution

  • 04779049590105 ()
NA

  • 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
4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
USWP-100A
Not in Commercial Distribution

  • 04987670102370 ()


  • Ultrasound imaging system workstation
ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
USWS-900A
In Commercial Distribution

  • 04987670101014 ()


  • Ultrasound imaging system workstation
ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
TUW-U001S
In Commercial Distribution

  • 04987670100796 ()


  • Ultrasound imaging system workstation
No Description
SINGULAR HEALTH PTY LTD
3Dicom MD
In Commercial Distribution

  • 09309000371006 ()
v3.5.2

  • Radiology picture archiving and communication system workstation
Synapse Enterprise Viewer (EV) is a software-based enterprise image viewer used with general purpose servers and dedicated reading workstations. It allows for communication, reformatting, rendering on the server component and communication and display of DICOM and non-DICOM images as well as reports.
Fujifilm Healthcare Americas Corporation
Synapse Enterprise Viewer
In Commercial Distribution

  • 00854904006060 ()


  • Radiology picture archiving and communication system workstation
Synapse Mobility is a feature-rich DICOM and Non-DICOM image and report viewer. Synapse Mobility utilizes the latest server side rendering technology to stream imaging securely and fast to any authorized user, with the ability to open within applications, directly from your EHR, or on our mobile device apps.
Fujifilm Healthcare Americas Corporation
Synapse Mobility Base Package
In Commercial Distribution

  • 00854904006053 ()


  • Radiology picture archiving and communication system workstation
Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating whole slide images obtained from the Leica Aperio AT2 DX scanner or the Philips Ultra Fast Scanner.
Fujifilm Healthcare Americas Corporation
Synapse Pathology Software License
In Commercial Distribution

  • 00854904006039 ()


  • Radiology picture archiving and communication system workstation
Synapse MPR/Fusion software enables the display, comparison and fusion of 3D (MIP/MPR) of CT, MR, PET and SPECT studies. Typical users are radiologists, technologists and clinicians. Synapse MPR/Fusion is not intended for Mammography use.
Fujifilm Healthcare Americas Corporation
Synapse MPR Fusion Software License
In Commercial Distribution

  • 00854904006022 ()


  • Radiology picture archiving and communication system workstation
Developed with direction from cardiologists, Synapse Cardiovascular offers capabilities and tools that help streamline workflow, image review, and reporting for a variety of cardiac areas.
Fujifilm Healthcare Americas Corporation
Synapse Cardiology PACS Software License
In Commercial Distribution

  • 00854904006015 ()


  • Radiology picture archiving and communication system workstation
Synapse, Fujifilm Picture Archiving and Communication Software (PACS), is a medical imaging and information management system that helps radiologists archive and distribute the vast amounts of image information that are handled by their offices each day.
Fujifilm Healthcare Americas Corporation
Synapse Radiology PACS Software License
In Commercial Distribution

  • 00854904006008 ()


  • Radiology picture archiving and communication system workstation
MDNC-3521 SNES
Barco NV
MDNC-3521
In Commercial Distribution

  • 05415334050389 ()
K9300391A2X

  • Radiology picture archiving and communication system workstation
MDNC-3521 SPES
Barco NV
MDNC-3521
In Commercial Distribution

  • 05415334050372 ()
K9300390A2X

  • Radiology picture archiving and communication system workstation
MDNC-2521 SPES
Barco NV
MDNC-2521
In Commercial Distribution

  • 05415334050358 ()
K9300380A2X

  • Radiology picture archiving and communication system workstation
MDCC-6530
Barco NV
MDCC-6530
In Commercial Distribution

  • 05415334049925 ()
K9301636B2X

  • Radiology picture archiving and communication system workstation
MDCC-4430
Barco NV
MDCC-4430
In Commercial Distribution

  • 05415334049895 ()
K9301626B2X

  • Radiology picture archiving and communication system workstation
MDNC-12130 H NC
Barco NV
MDNC-12130
In Commercial Distribution

  • 05415334049734 ()
K9301132A2X

  • Radiology picture archiving and communication system workstation
MDCC-4430 MDT
Barco NV
MDCC-4430
In Commercial Distribution

  • 05415334046610 ()
K9301629B1X

  • Radiology picture archiving and communication system workstation
MDMC-32133 E
Barco NV
MDMC-32133
In Commercial Distribution

  • 05415334046511 ()
K9301401A2X

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

  • 05415334043916 ()
K9300330B1X

  • Radiology picture archiving and communication system workstation
MDNC-3521 SPES
Barco NV
MDNC-3521
In Commercial Distribution

  • 05415334043770 ()
K9300390A1X

  • Radiology picture archiving and communication system workstation
MDNC-2521 SNES
Barco NV
MDNC-2521
In Commercial Distribution

  • 05415334043763 ()
K9300381A1X

  • Radiology picture archiving and communication system workstation
MDNC-2521 SPES
Barco NV
MDNC-2521
In Commercial Distribution

  • 05415334043749 ()
K9300380A1X

  • Radiology picture archiving and communication system workstation
MDNC-3521 SPES DE
Barco NV
MDNC-3521
In Commercial Distribution

  • 05415334043732 ()
K9300394A1X

  • Radiology picture archiving and communication system workstation
MDNC-3521 SNES
Barco NV
MDNC-3521
In Commercial Distribution

  • 05415334043725 ()
K9300391A1X

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

  • 05415334037533 ()
K9301648D

  • Radiology picture archiving and communication system workstation
MDNG-6221 SPEF
Barco NV
MDNG-6221
In Commercial Distribution

  • 05415334036895 ()
K9300370B

  • Radiology picture archiving and communication system workstation
MDNC-3421 HLX MKII
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334028333 ()
K9300345B

  • Radiology picture archiving and communication system workstation
MDCC-4430 NC
Barco NV
MDCC-4430
In Commercial Distribution

  • 05415334025981 ()
K9301628A

  • Radiology picture archiving and communication system workstation
MDCC-6530 NC
Barco NV
MDCC-6530
In Commercial Distribution

  • 05415334025974 ()
K9301638A

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

  • 05415334002623 ()
K9300333B

  • Radiology picture archiving and communication system workstation
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