VARO Plan Software is a stand-alone Windows-based software application to suppor
VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
DentiqAir is a software application for the visualization and segmentation of im
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.
Dentiq3D is a 3D visualization software for the analysis of various dental CT da
Dentiq3D is a 3D visualization software for the analysis of various dental CT data. Dentiq3D provides intuitive and real-time 3D volume processing functions.
The product mint Lesion helps qualified radiologists with the image-based diagno
The product mint Lesion helps qualified radiologists with the image-based diagnosis and treatment response assessment of oncological diseases. Fields of application are radiological diagnosis and follow-up examinations in oncology, as well as clinical or pharmaceutical drug trials across a defined group of patients. mint Lesion implements various radiological guidelines and response evaluation criteria, such as RECIST (Response Evaluation Criteria In Solid Tumors). This also includes the assessment of the stage of oncological disease (staging) and the objective response to therapy (e.g. timepoint response / overall response). The timepoint response is an empirical measure to evaluate therapy success according to the response criteria in use. It is mainly used to assess patient cohorts in the course of clinical trials of novel therapy agents. The timepoint response may differ from a radiological assessment of response to therapy and must not be used as a surrogate. mint Lesion allows for the documentation of size and assessment of changes in size of solid tumors described by the respective criteria that are monitored by means of radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine (PET, NM), digital radiography (XR, CR)). mint Lesion follows the typical workflow of follow-up examinations, from assessment to reporting, and enables the integration of a clinical-radiological software environment (PACS, Picture Archiving and Communication System). Assessment results can be exported into different electronical formats and processed further by other applications.
ClearRead Compare on Docker Platform.Primary DI Number should be M722XD20104T200
ClearRead Compare on Docker Platform.Primary DI Number should be M722XD20104T200370.Re-entered on 12/30/2020.
ClearRead Compare on Docker Platform.Primary DI Number mistyped as M722XD20104T2
ClearRead Compare on Docker Platform.Primary DI Number mistyped as M722XD20104T20370.Originally entered on 5/19/2020.
ClearRead Confirm on Docker PlatformPrimary DI Number should be M722XD20104L2003
ClearRead Confirm on Docker PlatformPrimary DI Number should be M722XD20104L200370.Re-entered on 12/30/2020.
ClearRead Confirm on Docker PlatformOriginally mistyped as M722XD20104L20370.Ori
ClearRead Confirm on Docker PlatformOriginally mistyped as M722XD20104L20370.Originally entered on 5/19/2020.
ClearRead Enhanced on Docker Platform.Primary DI Number should be M722XD20104E20
ClearRead Enhanced on Docker Platform.Primary DI Number should be M722XD20104E200370.Re-entered 12/30/2020.
ClearRead Enhanced on Docker Platform.Primary DI Number mistype as M722XD20104E2
ClearRead Enhanced on Docker Platform.Primary DI Number mistype as M722XD20104E20370.Original submission date 5/19/2020.
ClearRead Bone Suppress on Docker Platform.Primary DI Number should be M722XD201
ClearRead Bone Suppress on Docker Platform.Primary DI Number should be M722XD20104B200370.Re-entered 12/30/2020.
ClearRead Bone Suppress on Docker Platform.Primary DI Number mistyped as M722XD2
ClearRead Bone Suppress on Docker Platform.Primary DI Number mistyped as M722XD20104B20370.Originally entered on 5/19/2020