ABBOTT LABORATORIES 04T073A ARCHITECT

Software used in combination with the THxIDTM- BRAF assay(used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations)

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.

EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.

NB-TMP:The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Burr, Oval, 10 flute, 3.0mm

The Maxxi Position Sensor is intended for use with the polysomnograph system to acquire the body position of adult patients during sleep studies

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

Linux version

Lunit INSIGHT CXR Triage - Windows version

Software used in combination with the THxIDTM- BRAF assay(used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations)

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.

EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.

NB-TMP:The temperature sensor provides a signal that corresponds with (variations in) peripheral skin temperature when connected to a NeXus signal acquisition device. The sensor shall be placed on intact skin to provide a signal that is influenced by cutaneous blood flow. The sensor is not intended to determine directly or indirectly a measure of core body temperature and to be used for vital monitoring purposes.The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.