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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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The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
VERDURE IMAGING, INC.
000010
In Commercial Distribution

  • G618000010 ()


  • Ultrasound imaging system operation software
  • Hand-held ultrasound imaging system, body-surface
  • Ultrasound imaging system operator console
Galilei G6 Lens Professional
SIS AG, Surgical Instrument Systems
G6
In Commercial Distribution

  • 07640167751242 ()
410.030.007

  • Optical low coherence reflectometry (OLCR) biometer
  • Eye anterior segment analyser
  • Corneal topography system application software
The iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system.
TRACEY TECHNOLOGIES, CORPORATION
iTrace
In Commercial Distribution

  • 00860479001706 ()
Z2000

  • Corneal topography system
  • Automated ophthalmic refractometer
Pathway® CTS 1500
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS1500
In Commercial Distribution

  • 00852423006028 ()
CTS1500

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
Pathway® CTS 2000
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS2000
In Commercial Distribution

  • 00852423006011 ()
CTS2000

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
iVue NR for iFusion USCFG System w/ 230V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006308 ()
700-48586-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion System w/ 230V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006292 ()
700-48585-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion USCFG System w/ 120V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006247 ()
700-48371-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion System w/ 120V Table
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006230 ()
700-48363-003

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
iVue NR for iFusion USCFG 230V
OPTOVUE, INC.
iFusion
In Commercial Distribution

  • 00858848006209 ()
700-49003-004

  • Ophthalmic fundus camera
  • Ophthalmic spectral-domain optical coherence tomography system
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