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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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Airo® - 00869346000200

AIRO® Computed Tomography (CT) X-ray System
MOBIUS IMAGING, LLC
MobiCT-32
In Commercial Distribution

  • 00869346000200 ()
  • 10869346000207 ()
MobiCT-32

  • Full-body CT system

EDDA TECHNOLOGY - 00868466000237

IQQA-Guide is intended for intra-operative guidance for surgical procedures
EDDA TECHNOLOGY, INC.
IQQA-Guide
In Commercial Distribution

  • 00868466000237 ()


  • Electromagnetic surgical navigation device tracking system

Certus® 140 - 00853719006180

NEUWAVE AC System - 120V
NEUWAVE MEDICAL, INC.
2.45 GHz Ablation System
Not in Commercial Distribution

  • 00853719006180 ()
DR-000783

  • Microwave ablation system generator

iCT - 00857534006219

iCT System 115219-000
IMRIS Imaging, Inc.
iCT System
In Commercial Distribution

  • 00857534006219 ()


  • Full-body CT system

MiniCATIQ+ - 00860008443755

No Description
XORAN TECHNOLOGIES LLC
10040
In Commercial Distribution

  • 00860008443755 ()


  • Cone beam computed tomography system, head/neck

MiniCATIQ - 00860008443731

No Description
XORAN TECHNOLOGIES LLC
10015
In Commercial Distribution

  • 00860008443731 ()


  • Cone beam computed tomography system, head/neck

MiniCAT2020 - 00860290000353

No Description
XORAN TECHNOLOGIES LLC
10020
In Commercial Distribution

  • 00860290000353 ()


  • Cone beam computed tomography system, head/neck

MiniCATIQ - 00860290000315

MiniCATIQ is a compact, upright volume computed tomography system designed for highresolution, bone window imaging of the sinuses, temporal bones, and skull base. MiniCATIQ provides immediate access to images at the patient’s point-of-care resulting in a faster diagnosis and treatment. The MiniCATIQ is an X-ray imaging device that constructs a three-dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCATIQ is optimized for the imaging of the maxillofacial complex, temporal bone, and sinuses.
XORAN TECHNOLOGIES LLC
10009
In Commercial Distribution

  • 00860290000315 ()


  • Cone beam computed tomography system, head/neck

MiniCAT - 00860290000308

No Description
XORAN TECHNOLOGIES LLC
10004
In Commercial Distribution

  • 00860290000308 ()


  • Cone beam computed tomography system, head/neck

ECG CT Gating Cable - 00856181003336

The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.
NEOCOIL, LLC
33
In Commercial Distribution

  • 00856181003336 ()


  • Electrocardiograph, professional, multichannel
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