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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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SafeCT - 07290016836004

The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, processes and transfers CT images, using the DICOM protocol. The processing enhances image quality by reduction of the image noise.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.2
In Commercial Distribution

  • 07290016836004 ()


  • CT system application software

CT LVAS - 19356870000021

CT LVAS (CT:V) software is a non-invasive image processing technology that utilizes a paired inspiration-expiration CT to quantify and visualize regional and global ventilation within the lungs. The device provides physicians with additional clinical data to support management of pulmonary disease. Quantification and visualizations are provided in the form of a report.
4DMEDICAL LIMITED
1.x
In Commercial Distribution

  • 19356870000021 ()


  • CT system application software

XV Lung Ventilation Analysis Software - 19356870000014

The XV Lung Ventilation Analysis Software is a software-based image processing technology that analyzes cinefluorograph images in combination with a CT image to quantify ventilation of pulmonary tissue, thereby providing support to physicians in their assessment of patients with lung diseases. The XV Lung Ventilation Analysis Software measures the tissue motion of the lung, at all locations throughout the lung, and at all phases of the breath. It uses these motion measurements to calculate the 4-dimensional (4D) ventilation of lung tissues. Quantification and statistics are provided in the form of a Report. The key outputs are: • The tidal volume (i.e. total lung ventilation), presented as a single value; • Visualization of lung ventilation with color-defined specific ventilation ranges; • The heterogeneity of lung ventilation, presented as three values; and • Ventilation graph/ histogram of the classified lung voxel’s relative frequencies including ventilation defect percentage.
4DMEDICAL LIMITED
XV LVAS
In Commercial Distribution

  • 19356870000014 ()


  • CT system application software

NobelClinician® - 07332747125177

NobelClinician 3.1 for MAC
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125177 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747125160

NobelClinician 3.1 for Windows 64-bit
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125160 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747125153

NobelClinician 3.1 for Windows 32-bit
Nobel Biocare AB
3.1
Not in Commercial Distribution

  • 07332747125153 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747124972

NobelClinician 2.8 for Windows MAC
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124972 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747124958

NobelClinician 2.8 for Windows 64-bit
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124958 ()
101560

  • General-purpose dental x-ray system application software

NobelClinician® - 07332747124941

NobelClinician 2.8 for Windows 32-bit
Nobel Biocare AB
2.8
Not in Commercial Distribution

  • 07332747124941 ()
101560

  • General-purpose dental x-ray system application software

Stellar Exoscope - 06973031299382

No Description
Guangdong Optomedic Technologies, Inc.
31103FA
In Commercial Distribution

  • 06973031299382 ()


  • Surgical microscope video camera, sterilizable

uDR - 00810030350002

The uDR 596i Radiographic system is intended to be used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.
UIH TECHNOLOGIES LLC
uDr 596i
In Commercial Distribution

  • 00810030350002 ()


  • Stationary basic diagnostic x-ray system, analogue

Selenia Dimensions C-View Software - 15420045500020

Selenia® Dimensions® C-View Software is a software feature where a standard digital mammography image is generated from data acquired during a standard resolution breast tomosynthesis scan.
Hologic, Inc.
C-View
In Commercial Distribution

  • 15420045500020 ()
SW-03052

  • Basic diagnostic x-ray system application software

VEA Align - 03663999000412

No Description
EOS IMAGING
3.x
In Commercial Distribution

  • 03663999000412 ()


  • Basic diagnostic x-ray system application software

Focalist System - 00850062065000

No Description
Mendaera, Inc.
C001-01
In Commercial Distribution

  • 00850062065000 ()

  • Weight: 75 Kilogram


  • Ultrasound imaging system operator console

HALO SYSTEM COMPONENT - 00650551098393

RING/BLOCK ATTACH HARDWARE SET: (4) SHCS, (4)WASHER, (1)ALLEN WRENCH FOR CLOSED BACK RINGS
PMT CORPORATION
1201-37
In Commercial Distribution

  • 00650551098393 ()


  • Cervical spine immobilization system, single-use

IMAGE DIAGNOSTICS, INC - 00850061871367

IDI,RADIATION PROTECTION SYSTEM,LEADED ACRYLIC WINDOW,COMPASS CONTOUR SUSPENSION,SINGLE ARM,130MM THREADED HARDWARE#A610-0211-130
IMAGE DIAGNOSTICS, INC.
Compass Contour Suspended System with 1 Arm
In Commercial Distribution

  • 00850061871367 ()
A610-0211-130

  • Radiation shielding panel, portable/mobile

Axiom - 00840363368634

4 x 5 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368634 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLAS4X5PBR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368627

3 x 4 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368627 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLAS3X4PBR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368573

4 x 5 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368573 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLLAS4X5PBL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368566

3 x 4 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368566 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLAS3X4PBL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368511

4 x 5 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368511 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLLAS4X5PBP

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368504

3 x 4 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368504 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLAS3X4PBP

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368450

4 x 5 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368450 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLAS4X5PBR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368443

3 x 4 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368443 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLAS3X4PBR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368399

4 x 5 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368399 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLAS4X5PBL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368382

3 x 4 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368382 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLAS3X4PBL

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368337

4 x 5 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368337 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLAS4X5PBP

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368320

3 x 4 Lateral Pads with Adjustable Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368320 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLAS3X4PBP

  • Wheelchair head/trunk support, prefabricated

Footplate Heel Cup - 07540147002251

Optional Rubber Coated Footplate Heel Cups for use with MC Individual Footplate Assemblies. (Mounting hardware included)
Motion Concepts Inc
D-0130-0182-HC
In Commercial Distribution

  • 07540147002251 ()
HC

  • Wheelchair footrest/legrest

Everest & Jennings - M368907632C3A1

CROSSBRACE 20W - ADJUSTABLE DEPTH & CBOLT-PR (INCLUDES 4 LINKAGES, 4 BRACKETS, 2 SADDLE BUSHINGS, 2 GASKETS & HARDWARE)
GF HEALTH PRODUCTS, INC.
907632C3A
In Commercial Distribution

  • M368907632C3A1 ()
907632C3A

  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

Everest & Jennings - M368907632C2A1

CROSSBRACE 18W - ADJUSTABLE DEPTH &CBOLT-PR (INCLUDES 4 LINKAGES,4 BRACKETS, 2 SADDLE BUSHINGS, 2 GASKETS & HARDWARE)
GF HEALTH PRODUCTS, INC.
907632C2A
In Commercial Distribution

  • M368907632C2A1 ()
907632C2A

  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

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 - 00615521031688

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.. - 1 Streaming Channel FHD (H.264 high-profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031688 ()
VR401111-1DT

  • 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

HELION - 00615521031664

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.. - 1 Streaming Channel FHD (H.264 high- profile compression)
VIDEOMED SRL
116001
In Commercial Distribution

  • 00615521031664 ()
VR401111-1T

  • Operating room audiovisual data/device management system

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

Tissue-Tek® SmartWrite® - 00615233012494

Cassette Printer
SAKURA FINETEK U.S.A., INC.
9022
In Commercial Distribution

  • 00615233012494 ()
9022

  • Computed radiography digital imaging scanner

Li-Polymer Battery Pack - 04547410530650

The product is used to supply power for SE.
FUJIFILM CORPORATION
DR1280 SE BATTERY E
In Commercial Distribution

  • 04547410530650 ()


  • Diagnostic x-ray digital imaging conversion system

DR-ID 1280PB - 04547410530643

The DR-ID 1280PB supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunication between the flat panel sensor and the image processing unit connected beforehand. Also, it transfers images acquired by the flat panel sensor to the image processing unit.
FUJIFILM CORPORATION
DR-ID 1280 PB E
In Commercial Distribution

  • 04547410530643 ()


  • Diagnostic x-ray digital imaging conversion system

DR-ID 1280MP - 04547410530636

The DR-ID 1280MP supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunication between the flat panel sensor and the image processing unit connected beforehand. Also, it transfers images acquired by the flat panel sensor to the image processing unit.
FUJIFILM CORPORATION
DR-ID 1280 MP E
In Commercial Distribution

  • 04547410530636 ()


  • Diagnostic x-ray digital imaging conversion system

DR-ID 1285SE - 04547410530629

The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1285 SE E
In Commercial Distribution

  • 04547410530629 ()


  • Diagnostic x-ray digital imaging conversion system
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