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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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Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and pathology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants. Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review. In the United States only: - Mammographic images must be reviewed on a monitor approved by FDA for mammographic images - The Sectra Workstation is not intended for primary diagnosis of digital pathology images. Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used. Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether videos or photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used (e.g., size, resolution and contrast).
Sectra AB
19.3
In Commercial Distribution

  • 07350092810050 ()


  • Radiology picture archiving and communication system workstation
Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up. The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images.
Sectra AB
10.1
In Commercial Distribution

  • 07350092810043 ()


  • Radiology picture archiving and communication system workstation
Sectra Workstation is intended for the display, manipulation and diagnostic review of medical images (e.g. DICOM, jpeg, mpeg) and other related medical information. It can show images from different sources and interface with various image storage and printing devices. Areas of application include e.g. radiology (e.g. CR, DX, CT, MR, US), mammography, cardiology and pathology. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants. Lossy compressed radiological images and DICOM “for processing” images are not intended for diagnostic review. In the United States only: - Mammographic images must be reviewed on a monitor approved by FDA for mammographic images - The Sectra Workstation is not intended for primary diagnosis of digital pathology images. Sectra UniView, the web-based model of Sectra Workstation, is primarily intended for reference viewing on both stationary and mobile platforms. It is not intended for replacing a full diagnostic workstation but can be used on stationary platforms for diagnostic review of medical images except mammograms. For diagnostic review of radiological images full image quality mode must be used. Note: The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether videos or photographs, audio or text. Further, the user is responsible for the clinical adequacy of the viewing device used (e.g., size, resolution and contrast).
Sectra AB
19.1
In Commercial Distribution

  • 07350092810036 ()


  • Radiology picture archiving and communication system workstation
Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up. The device has functionality for overlaying prosthesis templates on radiological images, tools for repositioning bone and templates, and tools for measurements in the images.
Sectra AB
9.2
In Commercial Distribution

  • 07350092810029 ()


  • Radiology picture archiving and communication system workstation
Sectra Workstation is intended for the display and manipulation of medical images and other related medical information. It can show images from different sources and interface with various image storage and printing devices using DICOM and similar interface standards. Areas of application include, e.g., radiology, mammography, pathology, orthopedic preoperative planning and postoperative follow-up. Lossy compressed mammographic images are not intended for diagnostic review. For primary diagnosis, post-process DICOM “for presentation” images should be used. Typical users are trained medical professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.
Sectra AB
18.2
In Commercial Distribution

  • 07350092810012 ()


  • Radiology picture archiving and communication system workstation
No Description
MERGE HEALTHCARE SOLUTIONS INC.
8.0
Not in Commercial Distribution

  • 90842000100914 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
4.2
In Commercial Distribution

  • B334XD4P20 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
4.0
In Commercial Distribution

  • B334XD4P00 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
3.6
In Commercial Distribution

  • B334XD3P60 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
2.6
In Commercial Distribution

  • B334WORKFLOWBOX2P60 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
2.4
In Commercial Distribution

  • B334WORKFLOWBOX2P40 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
2.2
In Commercial Distribution

  • B334WORKFLOWBOX2P20 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
2.0
In Commercial Distribution

  • B334WORKFLOWBOX2P00 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
2.6
In Commercial Distribution

  • B334SY2P60 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
2.4
In Commercial Distribution

  • B334SY2P40 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
2.2
In Commercial Distribution

  • B334SY2P20 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
2.16
In Commercial Distribution

  • B334SY2P160 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
2.12
In Commercial Distribution

  • B334SY2P120 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
2.10
In Commercial Distribution

  • B334SY2P10 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
2.0
In Commercial Distribution

  • B334SY2P00 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
1.8
In Commercial Distribution

  • B334RTX1P80 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
1.6
In Commercial Distribution

  • B334RTX1P60 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
1.10
In Commercial Distribution

  • B334RTX1P100 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
4.4
In Commercial Distribution

  • B334NMX4P40 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
4.2
In Commercial Distribution

  • B334NMX4P20 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
1.4
In Commercial Distribution

  • B334DBX1P40 ()


  • Radiology picture archiving and communication system workstation
No Description
MIRADA MEDICAL LIMITED
1.0
In Commercial Distribution

  • B334ALINE1P00 ()


  • Radiology picture archiving and communication system workstation
No Description
CAScination AG
3.1.0
In Commercial Distribution

  • 07616962000212 ()
20072

  • Radiology picture archiving and communication system workstation
No Description
CAScination AG
2.0
In Commercial Distribution

  • 07640167222414 ()
20072

  • Radiology picture archiving and communication system workstation
No Description
CAScination AG
1.3
In Commercial Distribution

  • 07640167220724 ()
20072

  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.9.3
In Commercial Distribution

  • B148WSONE1930 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.9.2
In Commercial Distribution

  • B148WSONE1920 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.9.1
In Commercial Distribution

  • B148WSONE1910 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.9.0
In Commercial Distribution

  • B148WSONE1900 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.9
In Commercial Distribution

  • B148WSONE1890 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.8
In Commercial Distribution

  • B148WSONE1880 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.7
In Commercial Distribution

  • B148WSONE1870 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.6
In Commercial Distribution

  • B148WSONE1860 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.5
In Commercial Distribution

  • B148WSONE1850 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.4
In Commercial Distribution

  • B148WSONE1840 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.3
In Commercial Distribution

  • B148WSONE1830 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.2
In Commercial Distribution

  • B148WSONE1820 ()


  • Radiology picture archiving and communication system workstation
WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.1
In Commercial Distribution

  • B148WSONE1810 ()


  • Radiology picture archiving and communication system workstation
No Description
CAScination AG
4.1
In Commercial Distribution

  • 07616962000250 ()
20016

  • Radiology picture archiving and communication system workstation
TPLAN 200 DESKTOP SYSTEM
THINK SURGICAL, INC.
105715
In Commercial Distribution

  • M9461057150 ()


  • Radiology picture archiving and communication system workstation
The OsiriX MD software is an interactive image display and navigation program that was designed for medical imaging modalities. It supports all types of images generated by variety of imaging equipment and scanners available today. It supports the DICOM standard for image communication as well as a variety of other image formats used in academic and research community. OsiriX MD will act as a DICOM viewer capable of connecting to a DICOM network. OsiriX MD will be able to connect to various networked PACS, modalities and other DICOM nodes through the DICOM protocol over a TCP/IP network. OsiriX MD will provide manipulation tools for medical images. It also provides the necessary tools to query DICOM nodes, retrieve images from them and send images. OsiriX MD will also permit the efficient storage, and retrieval of medical images for imaging workstations. OsiriX MD is tailored for large sets of multidimensional and multi-modality images such as combined PET-CT studies that require three dimensional image fusion and volume rendering. The software is developed on MacOS platform. The software was developed in Objective-C in Apple Xcode development environment. In the design of the software a special attention was given to adapt the user interface to navigating through large sets of image data. The graphical user interface also uses the MacOS interface. Users can change and customize the software by adding and removing tools and items from the program toolbar and menu bars. This allows for adapting the software for number of functions and avoiding the users to be overwhelmed by an excessive number of unnecessary tools and functions that are not always needed.
Pixmeo Sàrl
OsiriX MD
In Commercial Distribution

  • 07649990819006 ()
14.1.2

  • Radiology picture archiving and communication system workstation
ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication System (PACS), is a medical imaging information system that securely transmits, receives, and archives digitally transmitted images and provides radiologists access to patient information, medical images, annotated print pages, transcribed reports.
INTUITIVE IMAGING INFORMATICS, LLC
ImageQube
In Commercial Distribution

  • B688IMAGEQUBE0 ()


  • Radiology picture archiving and communication system workstation
No Description
CANON MEDICAL SYSTEMS CORPORATION
CUW-U001S
In Commercial Distribution

  • 04987670104374 ()


  • Ultrasound imaging system workstation
The Orpheus System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real time with video-conferencing capability during the broadcast. The Orpheus System is not intended to be used as a primary diagnostic system for mammography and any other radiology application.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025001 ()
MVD-0001

  • Radiology picture archiving and communication system workstation
2MP Grayscale Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
G22S+
In Commercial Distribution

  • 06970027826249 ()


  • Radiology picture archiving and communication system workstation
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