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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 I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol.
First Source, Inc.
V5
In Commercial Distribution

  • G221200CA3080 ()
200-CA-308

  • Radiology DICOM image processing application software
A weight bearing stand that will allow a patient to be positioned for various x-ray examinations of spine and lower extremities.
First Source, Inc.
1
In Commercial Distribution

  • G221100DRSTS0 ()
100DRSTS

  • Radiological general body-part positioner
This Mobile X-ray System (Model: iQFlex M/iQFlex MD) consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, and a collimator. A cart or a stand can be used with the iQFlex MD. The iQFlex M/iQFlex MD is used with a film-cassette or flat-panel detector.
First Source, Inc.
MD
In Commercial Distribution

  • G221500MC0800 ()
500MC0800

  • Diagnostic x-ray system generator, portable
Mobile X-ray System consisting of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, and a collimator. The iQFlex M is used with a film-cassette or flat-panel detector.
First Source, Inc.
M
In Commercial Distribution

  • G221500MC0740 ()
500-MC-074

  • Diagnostic x-ray system generator, portable
A weight bearing stand that will allow a patient to be positioned for various U-Arm x-ray examinations of lower extremities.
First Source, Inc.
1
In Commercial Distribution

  • G221100DRWBS0 ()
100DRWBS

  • Radiological general body-part positioner
Accessory for installation under dental unit
Bien-Air Dental SA
1502056-001
In Commercial Distribution

  • J00715020560011 ()
1502056-001

  • Surgical power tool system control unit, line-powered
Accessory for installation beside dental unit
Bien-Air Dental SA
1501988-001
In Commercial Distribution

  • J00715019880011 ()
1501988-001

  • Surgical power tool system control unit, line-powered
iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution

  • J00714000630631 ()
1400063

  • Dental treatment application software
The AquariusNET Server, also known as iNtuition Server, receives, stores, transmits and post-processes medical images from acquisition devices, in both DICOM and non-DICOM format.
Terarecon Inc.
AQNet Server
In Commercial Distribution

  • INTUITION7 ()


  • Radiological PACS software
AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNtuitionEMV with a focus on 3D rendering, additionally providing workflow and scene support.
Terarecon Inc.
Aquarius Web
In Commercial Distribution

  • INTUITION6 ()


  • Radiological PACS software
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