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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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MERIDIAN MEDICAL SYSTEMS, LLC
RT 203
In Commercial Distribution

  • 00851354007029 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 202
In Commercial Distribution

  • 00851354007012 ()


  • Flat panel x-ray detector integration unit
No Description
MERIDIAN MEDICAL SYSTEMS, LLC
RT 201
In Commercial Distribution

  • 00851354007005 ()


  • Flat panel x-ray detector integration unit
Digital X-Ray flat panel detector used to acquire radiographic images of human anatomy when used with existing radiographic x-ray systems.
OSKO, INC.
Edge Air
In Commercial Distribution

  • 00869126000444 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-Ray Detector used to generate images of any part of the body. The system consists of a scintillator directly coupled to an a-Si TFT sensor. The system generates high-resolution and high-sensitive digital images.
OSKO, INC.
Edge
In Commercial Distribution

  • 00869126000437 ()


  • Indirect flat panel x-ray detector
CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consisting of a patient table, C-arm positioner, X-ray tube, X-ray generator, Flat Panel Detector and Image Processor. The system is configurable with selectable components i.e. tubes, generators, tables, c-arms and flat panel detectors per customer requirements.
OMEGA MEDICAL IMAGING, LLC
CS-series-FP
In Commercial Distribution

  • 00853901007018 ()


  • Stationary angiographic x-ray system, digital
CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4.
OMEGA MEDICAL IMAGING, LLC
CS50
In Commercial Distribution

  • 00853901007001 ()


  • Stationary angiographic x-ray system, digital
Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HQ901G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
17HQ901G-BP
In Commercial Distribution

  • 00195174039687 ()
17HQ901G-BP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 14HQ901G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
14HQ901G-BP
In Commercial Distribution

  • 00195174039663 ()
14HQ901G-BP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-BP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 10HQ701G-B, the 510k-approved DXD. "-BP" can be either model number or catalog number.
LG Electronics Inc.
10HQ701G-BP
In Commercial Distribution

  • 00195174039496 ()
10HQ701G-BP

  • Indirect flat panel x-ray detector
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