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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TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 41M
Not in Commercial Distribution

  • 00850951007487 ()
061000-500

  • Radiology picture archiving and communication system workstation
TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 41M
Not in Commercial Distribution

  • 00850951007470 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation
TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 41M
Not in Commercial Distribution

  • 00850951007463 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation
TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 40M
Not in Commercial Distribution

  • 00850951007456 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation
TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 SP 40M
Not in Commercial Distribution

  • 00850951007449 ()
061000-2000-SP

  • Radiology picture archiving and communication system workstation
TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 40M
Not in Commercial Distribution

  • 00850951007432 ()
061000-500

  • Radiology picture archiving and communication system workstation
TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS 2000 EN 39M
Not in Commercial Distribution

  • 00850951007425 ()
061000-2000-EN

  • Radiology picture archiving and communication system workstation
TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive.
FORESIGHT IMAGING, LLC
TIMS 500 39M
Not in Commercial Distribution

  • 00850951007401 ()
061000-500

  • Radiology picture archiving and communication system workstation
The Horos MD™ is an interactive image display and navigation software device for diagnosis of medical images. It provides both 2D and 3D image visualization tools for CT and MRI scans from different makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. Horos MD™ conforms to the DICOM standard to allow the sharing of medical images with other digital imaging systems such as PACS (Picture Archiving and Communication System). The Horos MD™ software device runs on the macOS X platform, taking advantage of its optimized 3D graphic capabilities, which are provided by the METAL framework developed and maintained by Apple Inc. The user interface of the software follows Apple's Human Interface Guidelines (HIG) in order to create a user interface that is intuitive and easy to use for users who are familiar with other Apple products. Typical users of this device are radiologists and clinicians who are familiar with 2D scan images.
ICAT SOLUTIONS LTD
HOROS MD
In Commercial Distribution

  • 05070002336808 ()


  • Radiology picture archiving and communication system workstation
The Falcon MD is an interactive medical image display software device for diagnostic image viewing of radiological images for the following modalities: X-ray, CT, MRI, Ultrasound, and XA for iOS and iPadOS platforms. The technological characteristics and the indications of use are identical to those of the Horos MD™ (K232589). The subject device provides both 2D and 3D image visualization tools for CT and MRI scans from various makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. The device is intended to be operated by radiologists, clinicians and other qualified physicians.
ICAT SOLUTIONS LTD
HOROS MOBILE
In Commercial Distribution

  • 05070002336815 ()


  • Radiology picture archiving and communication system workstation
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