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
Quantib B.V.
2.3
In Commercial Distribution

  • 08719689791124 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
1.1
In Commercial Distribution

  • 08719689791117 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
2.2
In Commercial Distribution

  • 08719689791100 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
1.0
In Commercial Distribution

  • 08719689791056 ()


  • Radiology DICOM image processing application software
No Description
Quantib B.V.
2.0
In Commercial Distribution

  • 08719689791049 ()


  • Radiology DICOM image processing application software
No Description
Cybermed Inc.
1.0
In Commercial Distribution

  • 08800023100006 ()


  • Radiology DICOM image processing application software
DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The software is intended to create design outputs to fabricate intraoral mandibular advancement devices used for the reduction of snoring. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. Output of DentiqAir has not been 510(k) cleared yet. The export of the device design file should only be sent to manufacturer who hold a 510(k) for intraoral mandibular advancement devices using DentiqAir software. The manufacture of the device should occur as per the design specifications provided within the 510(k) clearance.
3D Industrial Imaging Co.,Ltd
1.0
In Commercial Distribution

  • 08800022900072 ()


  • Radiology DICOM image processing application software
DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient’s CT image optionally aligned to an optical 3D surface data. Virtual crowns can be used to guide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing. Key Lock.
3D Industrial Imaging Co.,Ltd
1.0
In Commercial Distribution

  • 08800022900041 ()


  • Radiology DICOM image processing application software
syngo.via VB20A product label - about box
Siemens Healthcare GmbH
11298680
In Commercial Distribution

  • 04056869040134 ()


  • Radiology DICOM image processing application software
syngo.via VA30B "Stock Keeping Unit B" - product label DVD Media Cover: This unit contains the following registered Medical Devices:(1) syngo.via GTIN 04056869020976 (2) syngo.interventional GTIN 04056869020501 (3) syngo.CT Coronary Analysis GTIN 04056869007762(4) syngo.CT Cardiac Function - GTIN 04056869007779 (5) syngo.CT CaScoring - GTIN 04056869007786 (6) syngo.CT Vascular AnalysisGTIN 04056869007793 (7) syngo.CT Colonography - GTIN 04056869007809 (8) syngo.CT Pulmo3D - GTIN 04056869007816 (
Siemens Healthcare GmbH
11298690
In Commercial Distribution

  • 04056869033686 ()


  • Radiology DICOM image processing application software
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