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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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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 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
Sentiero AuDX PRO Set: Content: 1. Sentiero Diagnostic device AN100098-AUP 2. Carrying case AN100928 3. Inlay AN100677 4. Probe EP-DP Path long AN100028-US 5. Accessory box Combo AB-03 AN100261-BL 6. TEOAE Software AN100109 7. DPOAE Software AN100110 8. FMDPOAE Software AN100536 9. DPHiRes Software AN100537 10. Software label printer AN100414 11. PC Patient Management Software AN100116 12. USB data cable AN100089 13. USB stick Bio-Logic AN100724-BL 14. Power supply Sentiero AN101013+AN100993-USA 15. Manual Bio-Logic AN100904-EN-BL
PATH medical GmbH
8-04-16530
In Commercial Distribution

  • 04260223143489 ()
100250-BL-US4

  • Evoked-potential audiometer
Software medical device. Intended for use by professional healthcare providers for physiologic/hemodynamic monitoring, medical data processing and analytical assessment.
Philips Medical Systems Nederland B.V.
Philips Hemodynamic Application - 1
In Commercial Distribution

  • 00884838084544 ()
002010

  • Haemodynamic monitoring system application software
ViewPoint 6 v6.14
GE Healthcare GmbH
6. ver14
In Commercial Distribution

  • 00195278517340 ()
H47591YA

  • Medical image management system
  • Radiological PACS software
No Description
GE Healthcare GmbH
6 ver 6.7
Not in Commercial Distribution

  • 00840682103640 ()


  • Radiological PACS software
  • Medical image management system
ViewPoint 6 v6.12
GE Healthcare GmbH
6. ver12
In Commercial Distribution

  • 00840682171953 ()


  • Medical image management system
  • Radiological PACS software
ViewPoint 6 v6.11
GE Healthcare GmbH
6. ver11
Not in Commercial Distribution

  • 00840682145718 ()


  • Medical image management system
  • Radiological PACS software
ViewPoint 6 v6.10
GE Healthcare GmbH
6. ver10
Not in Commercial Distribution

  • 00840682140744 ()


  • Medical image management system
  • Radiological PACS software
ViewPoint 6 ver 6.9
GE Healthcare GmbH
6. ver6.9
Not in Commercial Distribution

  • 00840682124454 ()


  • Radiological PACS software
  • Medical image management system
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