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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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HELION - 00615521031657

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1 Streaming Channel FHD (H.264 high-profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031657 ()
VR401111-1TND

  • Operating room audiovisual data/device management system

HELION - 00615521031640

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031640 ()
VR401111-2

  • Operating room audiovisual data/device management system

HELION - 00615521031633

Helion Video Integration System - Main Unit (in-room intallation): - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031633 ()
VR401111-2D

  • Operating room audiovisual data/device management system

HELION - 00615521031626

Helion Video Integration System - Main Unit (in-room installation): - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server.. - 1 Streaming Channel FHD (H.264 high-profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031626 ()
VR401111-2DT

  • Operating room audiovisual data/device management system

HELION - 00615521031619

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 4TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server.. - 1 Streaming Channel FHD (H.264 high- profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031619 ()
VR401111-2T

  • Operating room audiovisual data/device management system

HELION - 00615521031602

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB SSD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031602 ()
VR401111-3

  • Operating room audiovisual data/device management system

HELION - 00615521031596

Helion Unit for manage 4K/UHD video signals (4096x2160 - 3840x2160). 5 x 5 Input/Output HDMI video channels at resolutions up to 4096x2160p. Main Feature: Integrated up / downscaling function for displaying FullHD video signals on 4K monitors, and 4K video signals on FullHD monitors; -Size 1 RU; Medical Grade Device.
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031596 ()
VR401112

  • Operating room audiovisual data/device management system

HELION - 00615521031589

Helion Unit for manage 4K/UHD video signals (4096x2160 - 3840x2160). 4 x 4 Input/Output 4xHDMI 4xDisplay Port video channels at resolutions up to 4096x2160p. Main Feature: Integrated up / downscaling function for displaying FullHD video signals on 4K monitors, and 4K video signals on FullHD monitors; -Size 1 RU; Medical Grade Device.
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031589 ()
VR401113

  • Operating room audiovisual data/device management system

HELION - 00615521031572

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031572 ()
VR401111-1

  • Operating room audiovisual data/device management system

HELION - 00615521031886

Helion Unit for manage bidirectional A/V videoconferencing. Main Features: - Dual channel transmission support; - Control directly via Helion GUI and Touchscreen; - Connections with remote users or any third-party videoconferencing unit supporting H.323 and SIP communication protocols; - Video Input/Output: FullHD bidirectional full duplex (2 separate video channels); - Audio: bidirectional full-duplex; - Protocols:H.323 and SIP.
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031886 ()
CM401326

  • Operating room audiovisual data/device management system

HELION - 00615521031695

Helion Video Integration System - Main Unit (in-room installation): - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist - Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD - 1st Recording Channel included (optional 2nd channel) - Buffering Function (MATS and Time Shift Recording) - Export: USB, PACS, Server..
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031695 ()
VR401111-1D

  • Operating room audiovisual data/device management system

HELION - 00615521031671

Helion Video Integration System - Main Unit: - Nr Inputs:18 - Nr Outputs:10 - Zero Latency System - Surgical checklist -Preset control - DICOM worklist - Ultra-compact design - Medical Device - Storage: 2TB HDD
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031671 ()
VR401111-1ND

  • Operating room audiovisual data/device management system

FUJI IP CASSETTE CC - 04547410211245

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BWPB 35.4X43.0cm(14X17)
In Commercial Distribution

  • 14547410211242 ()
  • 04547410211245 ()

  • 35.4X43.0 CM


  • Computed radiography digital imaging scanner

FCR PRIMA II - 04547410189988

The FCR PRIMA II (CR-IR 391RU) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
FUJIFILM CORPORATION
CR-IR 391RU
In Commercial Distribution

  • 04547410189988 ()


  • Computed radiography digital imaging scanner

FUJI IMAGING PLATE - 04547410177121

The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images.
FUJIFILM CORPORATION
IP-6 HR 24X30CM 2 M E
In Commercial Distribution

  • 14547410177128 ()
  • 04547410177121 ()
  • 84547410177127 ()

  • 24X30CM
47410-17712

  • Computed radiography digital imaging scanner

FUJI IMAGING PLATE - 04547410177114

The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images.
FUJIFILM CORPORATION
IP-6 HR 18X24CM 2 M E
In Commercial Distribution

  • 14547410177111 ()
  • 04547410177114 ()
  • 84547410177110 ()

  • 18X24CM
47410-17711

  • Computed radiography digital imaging scanner

FUJI IMAGING PLATE - 04547410149456

The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images.
FUJIFILM CORPORATION
IP ST-55 H 1M E+P14
In Commercial Distribution

  • 14547410149453 ()
  • 04547410149456 ()
47410-14945

  • Computed radiography digital imaging scanner

FUJI IMAGING PLATE - 04547410059434

The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images.
FUJIFILM CORPORATION
IP HR-BD 24X30CM 2 E
In Commercial Distribution

  • 14547410059431 ()
  • 04547410059434 ()
  • 84547410059430 ()

  • 24X30CM
47410-05943

  • Computed radiography digital imaging scanner

FUJI IMAGING PLATE - 04547410059427

The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images.
FUJIFILM CORPORATION
IP HR-BD 18X24CM 2 E
In Commercial Distribution

  • 14547410059424 ()
  • 04547410059427 ()
  • 84547410059423 ()

  • 18X24CM
47410-05942

  • Computed radiography digital imaging scanner

FUJI IMAGING PLATE - 04547410059359

The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images.
FUJIFILM CORPORATION
IP ST-BD 18X24CM 1 E
In Commercial Distribution

  • 14547410059356 ()
  • 04547410059359 ()

  • 18X24CM
47410-05935

  • Computed radiography digital imaging scanner
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