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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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No Description
KONAN MEDICAL, INC.
CellChek 20-1
In Commercial Distribution

  • 04582275250664 ()


  • Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
CC 20 rc
Not in Commercial Distribution

  • 04582275250657 ()


  • Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
CellChek 20
In Commercial Distribution

  • 04582275250626 ()


  • Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
NSPC
Not in Commercial Distribution

  • 04582275250374 ()


  • Eye anterior segment analyser
No Description
KONAN MEDICAL, INC.
NSP
Not in Commercial Distribution

  • 04582275250107 ()


  • Eye anterior segment analyser
NUCLeUS OR Controller
SONY CORPORATION
NU-MC30E
In Commercial Distribution

  • 04548736120679 ()


  • Operating room audiovisual data/device management system application software
Network System Manager
SONY CORPORATION
NU-NM30E
In Commercial Distribution

  • 04548736106291 ()


  • Operating room audiovisual data/device management system application software
No Description
TOPCON CORPORATION
SP-1P
In Commercial Distribution

  • 04562123288315 ()


  • Eye anterior segment analyser
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques. Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution

  • 00860002545707 ()


  • Ultrasound imaging system application software
Localization and characterization of thyroid ultrasound images.
SEE-MODE TECHNOLOGIES PTE. LTD.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
In Commercial Distribution

  • 00860006305727 ()


  • Ultrasound imaging system application software
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