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
19.1
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
2MP Grayscale Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
G22S+
In Commercial Distribution

  • 06970027826249 ()


  • Radiology picture archiving and communication system workstation
8MP Color LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
C81W+
In Commercial Distribution

  • 06970027826140 ()
CL3002*MBJFPD01

  • Radiology picture archiving and communication system workstation
2MP Grayscale Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
G23SP+
In Commercial Distribution

  • 06970027824665 ()


  • Radiology picture archiving and communication system workstation
6MP Color LCD Display
Shenzhen Beacon Display Technology Co., Ltd.
C61W+
In Commercial Distribution

  • 06970027823613 ()
CL3003*MBJFJE01

  • Radiology picture archiving and communication system workstation
2MP Grayscale Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
G22SP+
In Commercial Distribution

  • 06970027822500 ()


  • Radiology picture archiving and communication system workstation
3MP Grayscale Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
G32SP+
In Commercial Distribution

  • 06970027822418 ()


  • Radiology picture archiving and communication system workstation
8MP Integrated Dual-screen Display
Shenzhen Beacon Display Technology Co., Ltd.
C82W+
In Commercial Distribution

  • 06970027822296 ()


  • Radiology picture archiving and communication system workstation
5MP Grayscale Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
G53SP+
In Commercial Distribution

  • 06970027821237 ()


  • Radiology picture archiving and communication system workstation
2MP Grayscale Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
G23S+
In Commercial Distribution

  • 06970027821183 ()


  • Radiology picture archiving and communication system workstation
5MP Monochrome LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
MB5MP
In Commercial Distribution

  • 06970027821145 ()


  • Radiology picture archiving and communication system workstation
5MP Color LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
CB5MP
In Commercial Distribution

  • 06970027821138 ()


  • Radiology picture archiving and communication system workstation
5MP Grayscale Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
G53S+
In Commercial Distribution

  • 06970027821121 ()


  • Radiology picture archiving and communication system workstation
5MP Color Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
C53SP+
In Commercial Distribution

  • 06970027821107 ()


  • Radiology picture archiving and communication system workstation
3MP Monochrome LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
G316S
In Commercial Distribution

  • 06970027821022 ()


  • Radiology picture archiving and communication system workstation
3MP Monochrome LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
G310S
In Commercial Distribution

  • 06970027821015 ()


  • Radiology picture archiving and communication system workstation
5MP Color Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
C53S+
In Commercial Distribution

  • 06970027821008 ()


  • Radiology picture archiving and communication system workstation
5MP Monochrome LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
G516S
In Commercial Distribution

  • 06970027820995 ()


  • Radiology picture archiving and communication system workstation
5MP Color LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
C516S
In Commercial Distribution

  • 06970027820988 ()


  • Radiology picture archiving and communication system workstation
3MP Color LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
C316S
In Commercial Distribution

  • 06970027820971 ()


  • Radiology picture archiving and communication system workstation
6MP Color LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
C616W
In Commercial Distribution

  • 06970027820797 ()


  • Radiology picture archiving and communication system workstation
2MP Color Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
C22SP+
In Commercial Distribution

  • 06970027820780 ()


  • Radiology picture archiving and communication system workstation
5MP Monochrome LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
G510S
In Commercial Distribution

  • 06970027820773 ()


  • Radiology picture archiving and communication system workstation
5MP Color LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
C510S
In Commercial Distribution

  • 06970027820766 ()


  • Radiology picture archiving and communication system workstation
3MP Color LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
C310S
In Commercial Distribution

  • 06970027820759 ()


  • Radiology picture archiving and communication system workstation
12MP Color LCD Monitor
Shenzhen Beacon Display Technology Co., Ltd.
C1216W
In Commercial Distribution

  • 06970027820742 ()


  • Radiology picture archiving and communication system workstation
8MP Integrated Dual-screen Display
Shenzhen Beacon Display Technology Co., Ltd.
C85W+
In Commercial Distribution

  • 06970027820568 ()


  • Radiology picture archiving and communication system workstation
8MP Integrated Dual-screen Display
Shenzhen Beacon Display Technology Co., Ltd.
C83W+
In Commercial Distribution

  • 06970027820551 ()


  • Radiology picture archiving and communication system workstation
3MP Color Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
C32SP+
In Commercial Distribution

  • 06970027820544 ()


  • Radiology picture archiving and communication system workstation
3MP Grayscale Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
G32S+
In Commercial Distribution

  • 06970027820421 ()


  • Radiology picture archiving and communication system workstation
3MP Color Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
C32S+
In Commercial Distribution

  • 06970027820384 ()


  • Radiology picture archiving and communication system workstation
4MP Integrated Dual-screen Display
Shenzhen Beacon Display Technology Co., Ltd.
C44W+
In Commercial Distribution

  • 06970027820360 ()


  • Radiology picture archiving and communication system workstation
2MP Color Medical Display
Shenzhen Beacon Display Technology Co., Ltd.
C22S+
In Commercial Distribution

  • 06970027820001 ()


  • Radiology picture archiving and communication system workstation
The VMS+ 4.0 system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS+ 4.0 system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.
VentriPoint Diagnostics Ltd
4.0
In Commercial Distribution

  • 07540263000049 ()


  • Radiology picture archiving and communication system workstation
The VMS+ system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS+ system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.
VentriPoint Diagnostics Ltd
3.0
In Commercial Distribution

  • 07540263000025 ()


  • Radiology picture archiving and communication system workstation
The VMS+ system is an adjunct to existing ultrasound imaging systems and is intended to record, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The VMS+ system is indicated for use where Left Ventricle (LV), Right Ventricle (RV), Left Atrium (LA), and Right Atrium (RA) volumes and ejection fractions are warranted or desired.
VentriPoint Diagnostics Ltd
2.0
Not in Commercial Distribution

  • 07540263000018 ()


  • 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
No Description
CAScination AG
3.1.0
In Commercial Distribution

  • 07616962000212 ()
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
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