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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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VIDCO NetViewer - 00863067000303

Remote Central Station
VIDCO, INC
MDP2040-0100
In Commercial Distribution

  • 00863067000303 ()


  • Centralized patient monitor

PICA Whole-body MRI System - 00862694000304

No Description
TIME MEDICAL SYSTEMS
TMS-MRI-3500wb-02
In Commercial Distribution

  • 00862694000304 ()

  • Weight: 18500 Kilogram


  • Full-body MRI system, permanent magnet

ScanPoint® - 00879123006127

No Description
VERATHON INC
ScanPoint®
In Commercial Distribution

  • 00879123006127 ()


  • Ultrasound imaging system application software

ScanPoint® - 00879123004239

No Description
VERATHON INC
ScanPoint Local Client
In Commercial Distribution

  • 00879123004239 ()
0900-1009

  • Ultrasound imaging system application software

GutTracker - 00860011391500

GutTracker measures GI motility of the stomach, small intestine and colon non-invasively over multiple days as patients go about their normal daily lives.The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
G-TECH MEDICAL, INC.
Gen 2
In Commercial Distribution

  • 00860011391500 ()
  • 00860011391517 ()

  • Length: 3.3 Inch
1001

  • Wearable multiple vital physiological parameter monitoring system

Sirona Medical Radiology Platform - 00860011175803

No Description
Sirona Medical, Inc.
Model1
In Commercial Distribution

  • 00860011175803 ()


  • Radiology information system

AS-EMR SYSTEM; AS-OBGYN INFORMATION SYSTEM - 00860010575307

The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution

  • 00860010575307 ()


  • Ultrasound imaging system application software

Spire Health Remote Patient Monitoring System - 00860008932204

The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data.
CONVEXITY SCIENTIFIC LLC
700099
In Commercial Distribution

  • 00860008932204 ()


  • Wearable multiple vital physiological parameter monitoring system

Amimon - 00860014100673

MD52 Rx device
Amimon Inc.
MD52 Rx device - MDWL2_B3P1RX
In Commercial Distribution

  • 00860014100673 ()
MDWL2_B3P1RX

  • Medical image management system

Amimon - 00860014100635

MD11 Rx device
Amimon Inc.
MD11 Rx device - MDWL1_B1N1RX
In Commercial Distribution

  • 00860014100635 ()
MDWL1_B1N1RX

  • Medical image management system
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