Osteogenics Biomedical Inc ZF100 ZCORE FORM

This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6

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.

Olea S.I.A V1.0 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Olea S.I.A V1.0 stores, converts formats and displays medical device data.Olea S.I.A V1.0 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself.Olea S.I.A V1.0 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Olea S.I.A V1.0 reads DICOM tags and pixel data to label images.Olea S.I.A V1.0 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs.Olea S.I.A V1.0 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan.Olea S.I.A V1.0 is intended to be used by trained professionals. Olea S.I.A V1.0 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.

CINA is a radiological computer-assisted triage and notification software device.The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image processing applications.DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspicious results of an intracranial hemorrhage (ICH) or a large vessel occlusion (LVO), then notifications on the flagged series are sent to the Worklist Application.The Worklist Application (on premise) displays the pop-up notifications of new studies with suspected findings when they come in, and provides both active and passive notifications. Activenotifications are in the form of a small pop-up containing patient name, accession number and the type of suspected findings (ICH or LVO). All the non-enhanced head CT images and head CT angiographies studies received by CINA device are displayed in the worklist and those on which the algorithms have detected a suspected finding (ICH or LVO) are marked with an icon (i.e., passive notification). In addition, a compressed, small black and white image that is marked “not for diagnostic use” is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.

Burr, Oval, 10 flute, 3.0mm

The Automation Platform is a software product that transfers, stores, converts formats, and displays medical device image data. It does not modify the image data or modify the display of the image data. The Automation Platform reads images and interprets DICOM tags, analyzes pixels to identify body part and sequence type in order to categorize the images.The Automation Platform is not intended to be used for active patient monitoring nor primary image interpretation.The Automation Platform allows routing DICOM-compliant image data to and from automated post processing applications, but such processing applications are not a part of the platform itself.Automation Platform allows post processing applications to provide a notification or a flag intended to inform the user.

Voxel Dosimetry™ is a tool for voxel level absorbed dose calculation resulting from radiotracer injection. Voxel Dosimetry™ workflow consists of the following steps:• SPECT/CT or PET/CT DICOM data loading from the data manager GOLD or PACS• Registration of different time-points to a common reference study• Generation and integration of voxel-level time-activity curves• Voxel-level absorbed dose calculation using a Monte Carlo-method • Saving of the absorbed dose-map back to GOLD or PACS in DICOM format.Intended Use:The intended use of Voxel Dosimetry™ is to provide estimates (deterministic) of absorbed radiation dose at voxel level as a result of administering one of the supported radionuclides and to provide a dose map. This is dependent on input data regarding bio distribution being supplied to the application. Voxel Dosimetry™ only allows voxel-based dose calculations for patients who have been administered with radioisotopes. Warning! The Voxel Dosimetry™ is only intended for calculating dose for FDA approved radiopharmaceuticals for any clinical purpose, and calculation of unapproved drugs can only be used for research purpose.

kneeEOS allows surgeons to perform preoperative surgical planning of total kneearthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg.

This database entry covers UDI for SW Versions 1.0 and higher:(01)04049471070118(10)200 -> Version 2.0; (01)04049471070118(10)201-> Version 2.0.1; (01)04049471070118(10)251-> Version 2.5.1; (01)04049471070118(10)260-> Version 2.6

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.

Olea S.I.A V1.0 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Olea S.I.A V1.0 stores, converts formats and displays medical device data.Olea S.I.A V1.0 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself.Olea S.I.A V1.0 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Olea S.I.A V1.0 reads DICOM tags and pixel data to label images.Olea S.I.A V1.0 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs.Olea S.I.A V1.0 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan.Olea S.I.A V1.0 is intended to be used by trained professionals. Olea S.I.A V1.0 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.

CINA is a radiological computer-assisted triage and notification software device.The software system is based on algorithm-programmed components and is comprised of a standard off-the-shelf operating system and additional image processing applications.DICOM images are received, recorded and filtered before processing. The series are processed chronologically by running algorithms on each series to detect suspicious results of an intracranial hemorrhage (ICH) or a large vessel occlusion (LVO), then notifications on the flagged series are sent to the Worklist Application.The Worklist Application (on premise) displays the pop-up notifications of new studies with suspected findings when they come in, and provides both active and passive notifications. Activenotifications are in the form of a small pop-up containing patient name, accession number and the type of suspected findings (ICH or LVO). All the non-enhanced head CT images and head CT angiographies studies received by CINA device are displayed in the worklist and those on which the algorithms have detected a suspected finding (ICH or LVO) are marked with an icon (i.e., passive notification). In addition, a compressed, small black and white image that is marked “not for diagnostic use” is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the radiologist with notification facilitates earlier triage by allowing one to prioritize images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.