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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 Class Implantable

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X-CEL X-RAY CORPORATION - B216DRH700AC1

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

X-CEL X-RAY CORPORATION - B216BDXC7001

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
BDXC-700
In Commercial Distribution

  • B216BDXC7001 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715TBD1

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

  • B216715TBD1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715SD1

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

  • B216715SD1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715RSD1

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

  • B216715RSD1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715BBD1

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

  • B216715BBD1 ()


  • Stationary basic diagnostic x-ray system, analogue

TBS iNsight - B214OSTBSIV400

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

VARIANT - B030SPO1530010

Illuminator
CAMBER SPINE TECHNOLOGIES, LLC
SPO-153-001
In Commercial Distribution

  • B030SPO1530010 ()


  • Surgical microscope video camera, non-sterilizable

QCT PRO Asynchronous 3D Spine and CTXA-Hip System - B052QCTPROM4ASH0

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 4 Calibration Phantom
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM4ASH0 ()
  • QCTPROM4ASHN0100 ()
  • QCTPROM4ASHN0075 ()
  • QCTPROM4ASHN0050 ()
  • QCTPROM4ASHN0025 ()
  • QCTPROM4ASHN0010 ()
  • QCTPROM4ASHN0005 ()
  • QCTPROM4ASHN0003 ()
  • QCTPROM4ASHN0002 ()
  • QCTPROM4ASHN0500 ()
  • QCTPROM4ASHN0200 ()
QCTPROM4ASH

  • CT system application software

QCT PRO Asynchronous 3D Spine and CTXA-Hip System - B052QCTPROM3ASH0

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM3ASH0 ()
QCTPROM3ASH

  • CT system application software
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