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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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PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
FB-715NT
In Commercial Distribution

  • B216FB715NT1 ()


  • Stationary basic diagnostic x-ray system, analogue
TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
DRH-700 A/C
In Commercial Distribution

  • B216DRH700AC1 ()


  • Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
BDXC-700
In Commercial Distribution

  • B216BDXC7001 ()


  • Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715T-BD
In Commercial Distribution

  • B216715TBD1 ()


  • Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715-SD
In Commercial Distribution

  • B216715SD1 ()


  • Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715R-SD
In Commercial Distribution

  • B216715RSD1 ()


  • Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715B-BD
In Commercial Distribution

  • B216715BBD1 ()


  • Stationary basic diagnostic x-ray system, analogue
TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractal-like approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image.
medimaps group SA
4.0
In Commercial Distribution

  • B214OSTBSIV400 ()


  • Basic diagnostic x-ray system application software
The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional. The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format.
PULMONX CORPORATION
LIA-01-001
In Commercial Distribution

  • 00811907031819 ()


  • CT system application software
Site~Rite 8 Ultrasound System Console (Remanufactured)
Bard Access Systems, Inc.
9770600Y
In Commercial Distribution

  • 00801741138287 ()
9770600Y

  • Ultrasound imaging system operator console
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