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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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Male Bone Fixator
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0004
In Commercial Distribution

  • B432360CAS00040 ()


  • Robotic surgical navigation system application software
Large CAS Tracker
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0003
In Commercial Distribution

  • B432360CAS00030 ()


  • Robotic surgical navigation system application software
Small CAS Tracker
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0002
In Commercial Distribution

  • B432360CAS00020 ()


  • Robotic surgical navigation system application software
A self-standing software program that adds specific image processing and/or analysis capabilities to radiological DICOM image data.
QI IMAGING LLC
2.4.3.1
In Commercial Distribution

  • B131ZIOE1001SYS0P ()
ZIOE1001SYS

  • Radiology DICOM image processing application software
Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms.
Terarecon Inc.
Eureka AI Results Explorer
In Commercial Distribution

  • B2208430011 ()


  • Radiology DICOM image processing application software
AQAPS, also known as AquariusAPS Server, is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules.
Terarecon Inc.
AQAPS04
In Commercial Distribution

  • AQAPS04 ()
AQAPS

  • Radiology DICOM image processing application software
Web application
MC10, INC.
SW-0043
Not in Commercial Distribution

  • B493SW0043 ()


  • Electronic goniometer/kinesiology sensor
  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software
Patient application for Android
MC10, INC.
SW-0042
Not in Commercial Distribution

  • B493SW0042 ()


  • Electronic goniometer/kinesiology sensor
  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software
Instructions for use
MC10, INC.
MC-0016
Not in Commercial Distribution

  • B493MC0016 ()


  • Electronic goniometer/kinesiology sensor
  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software
MC-0011 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05, B493MC0009
MC10, INC.
MC-0011
Not in Commercial Distribution

  • B493MC0011 ()


  • Kinesiology ambulatory recorder
  • Biomechanical function analysis/rehabilitation software
  • Electronic goniometer/kinesiology sensor
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