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, cardiology and ophthalmology. 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. Only for the United States: - Mammographic images must be reviewed on a monitor approved by FDA for this purpose. 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 it 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. The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, 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
26.1
In Commercial Distribution

  • 07350092810517 ()


  • Radiology picture archiving and communication system workstation
Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images. For example the Sectra Orthopaedic Package shall: • Assist the orthopaedic surgeons in choosing which implants to use. • Assist the orthopaedic surgeons in choosing where to place cut lines etc. • Assist the orthopaedic surgeons in following-up of surgical procedures. • Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery. • Assist the radiologist in making MSK measurements. • Assist the user in producing outputs for post-processing such as 3D prints of anatomical models. Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists.
Sectra AB
17.2
In Commercial Distribution

  • 07350092810494 ()


  • 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, cardiology and ophthalmology. 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. Only for the United States: - Mammographic images must be reviewed on a monitor approved by FDA for this purpose. 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 it 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. The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, 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
25.2
In Commercial Distribution

  • 07350092810470 ()


  • Radiology picture archiving and communication system workstation
Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images. For example the Sectra Orthopaedic Package shall: • Assist the orthopaedic surgeons in choosing which implants to use. • Assist the orthopaedic surgeons in choosing where to place cut lines etc. • Assist the orthopaedic surgeons in following-up of surgical procedures. • Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery. • Assist the radiologist in making MSK measurements. • Assist the user in producing outputs for post-processing such as 3D prints of anatomical models. Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists.
Sectra AB
17.1
In Commercial Distribution

  • 07350092810463 ()


  • 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, cardiology and ophthalmology. 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. Only for the United States: - Mammographic images must be reviewed on a monitor approved by FDA for this purpose. 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 it 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. The user is responsible for the quality, accuracy and adequacy of all information imported or entered into Sectra Workstation, whether it is videos, 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
25.1
In Commercial Distribution

  • 07350092810449 ()


  • Radiology picture archiving and communication system workstation
Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images. For example the Sectra Orthopaedic Package shall: • Assist the orthopaedic surgeons in choosing which implants to use. • Assist the orthopaedic surgeons in choosing where to place cut lines etc. • Assist the orthopaedic surgeons in following-up of surgical procedures. • Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery. • Assist the radiologist in making MSK measurements. • Assist the user in producing outputs for post-processing such as 3D prints of anatomical models. Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists.
Sectra AB
16.2
In Commercial Distribution

  • 07350092810432 ()


  • 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 ophthalmology. 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. Only for the United States: - Mammographic images must be reviewed on a monitor approved by FDA for this purpose. 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 it 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 it is videos, 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
24.2
In Commercial Distribution

  • 07350092810418 ()


  • Radiology picture archiving and communication system workstation
Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, making musculoskeletal (MSK) measurements and post-operative follow-up. The device has functionality in both 2D and 3D for viewing prosthesis templates on radiological images, tools for repositioning bones and templates, and tools for measurements in the images. For example the Sectra Orthopaedic Package shall: • Assist the orthopaedic surgeons in choosing which implants to use. • Assist the orthopaedic surgeons in choosing where to place cut lines etc. • Assist the orthopaedic surgeons in following-up of surgical procedures. • Assist the orthopaedic surgeon in planning trauma, joint, spine and deformity surgery. • Assist the radiologist in making MSK measurements. • Assist the user in producing outputs for post-processing such as 3D prints of anatomical models. Typical users of this system are trained professionals, for example orthopaedic surgeons, physicians, and radiologists.
Sectra AB
16.1
In Commercial Distribution

  • 07350092810401 ()


  • 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 ophthalmology. 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. Only for the United States: - Mammographic images must be reviewed on a monitor approved by FDA for this purpose. 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 it 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 it is videos, 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
24.1
In Commercial Distribution

  • 07350092810371 ()


  • 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
15.1
In Commercial Distribution

  • 07350092810364 ()


  • 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 ophthalmology. 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. Only for the United States: - Mammographic images must be reviewed on a monitor approved by FDA for this purpose. 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 it 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 it is videos, 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
23.2
In Commercial Distribution

  • 07350092810357 ()


  • Radiology picture archiving and communication system workstation
IntelliSpace Clinical Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. IntelliSpace Clinical Applications software receives image data from medical scanning devices, such as, but not limited to, CT and MRI, or from image archives. IntelliSpace Clinical Applications performs viewing, image manipulation, communication, printing, and quantification of images.
Philips Medical Systems Nederland B.V.
IntelliSpace Clinical Applications - 8
In Commercial Distribution

  • 00884838125940 ()
837509

  • Radiology picture archiving and communication system workstation
IntelliSpace Radiology is a software package intended to be used by trained professionals, including but not limited to physicians, administrators and medical technicians. The software is used with general purpose computing hardware for the presentation, processing, measurement and distribution of images and associated data throughout a clinical environment. IntelliSpace Radiology software supports receiving, sending, printing, and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, CR, DX, DR, RF, RT, MG, SC, VL, and OP as well as hospital/radiology information systems. IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to Mammography. Lossy compressed mammographic images and digitized film/screen images must not be reviewed for primary image interpretations.
Philips Medical Systems Nederland B.V.
IntelliSpace Radiology - 4
In Commercial Distribution

  • 00884838123809 ()
836344

  • Radiology picture archiving and communication system workstation
IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide clinicians with convenient access to the detailed records of all cardiac patients across their complete cardiovascular care continuum. The application also provides hospital administrators and department managers with detailed operational information, as well as productivity and outcomes reporting. Key components include a wide range of detailed clinical modules that capture data during diagnostic/therapeutic procedures and patient follow–up encounters. Interfaces to other systems and devices within the cardiology departments as well as across the enterprise system, such as HIS/EMR, are available. The solution supports a remote deployment model.
Philips Medical Systems Nederland B.V.
8
In Commercial Distribution

  • 00884838122000 ()
830089

  • Radiology picture archiving and communication system workstation
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
7
In Commercial Distribution

  • 00884838115378 ()
830089

  • 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
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