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510(k) Data Aggregation
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This software is a medical device intended for the visualization of various intensity modulation including FFT filter. It receives, stores, processes, and displays sequential DICOM images primarily obtained through low-dose chest fluoroscopy (e.g., RF and AX modalities).
This software is not intended to be used for primary diagnosis. Reference images such as scintigraphy or CT scans may be displayed for supplementary purposes. This software is intended for use in adult patients only.
The subject device is the software device that receives, stores, processes, and displays sequential DICOM images including the intensity modulation primarily obtained through chest fluoroscopy (e.g., RF and AX modalities). The software is compatible with external systems such as hospital PACS via DICOM-compliant communication protocols.
The device incorporates a intensity modulation mode image including fast Fourier transform (FFT), which extracts time-varying components corresponding to lower and higher frequency band pass filter in chest XP dynamics. When appropriate image acquisition conditions are met (e.g., fixed exposure, no post-processing, sufficient number of frames), the software generates differential projection images:
- RDP (Lower frequency band pass filter modulated projection in chest XP dynamic imaging)
- BDP (Higher frequency band pass filter modulated projection in chest XP dynamic imaging)
Additionally, the software can compute time-compressed summary images (e.g., MEDP, MIDP, MBDP), which provide intuitive visualization of regional changes, similar to maximum intensity projection techniques used in CT imaging. The device operates as a standalone application, with all processing and visualization of the intensity modulation integrated into a single software package.
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(77 days)
PHT-70CHS is intended to produce panoramic, cephalometric, or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus, and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.
The PHT-70CHS is a 4-in-1 digital X-ray system designed for both 2D and 3D dental radiographic imaging. The system integrates panoramic imaging, optional cephalometric imaging, dental computed tomography, and model imaging functions into a single unit. It is intended for dental diagnostic purposes and is capable of acquiring and processing multi-field-of-view digital radiographic images.
The PHT-70CHS is a complete digital radiographic imaging system that includes an X-ray generator, dedicated image receptors, and compatible image viewing software. The system supports acquisition of both 2D diagnostic images, including panoramic and cephalometric images, and 3D diagnostic images using cone beam computed tomography.
The materials, safety characteristics, X-ray source, indications for use, and image reconstruction including metal artifact reduction algorithms of the subject device are the same as those of the predicate devices PHT-75CHS (K231796) and PHT-90CHO (K243081).
Green X 12 VE and Green X VE are differentiated by the configuration of the CT and panoramic image receptors, which is reflected in their respective trade naming. Green X 12 VE is equipped with the Xmaru1404CF-PLUS Eth detector, while Green X VE is equipped with the Jupi0606X1 detector. Both configurations utilize the Xmaru2602CF Eth detector for cephalometric imaging.
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(110 days)
Avatar Medical Vision is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images on a standard (non-stereoscopic) screen in the operating room, and on an autostereoscopic screen or VR headset in a non-sterile room. Avatar Medical Vision is designed for use by healthcare professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
Avatar Medical Vision is a software-only device that allows medical professionals to review CT and MR image data in three-dimensional (3D) format on a standard (non-stereoscopic) or autostereoscopic computer screen and/or in virtual reality (VR) interface. The 3D and VR images are accessible through the software desktop application, on a standard (non-stereoscopic) or autostereoscopic computer screen, and, if desired, through compatible VR headsets. Images are used by users for preoperative surgical planning and for display during intervention/surgery.
The Avatar Medical Vision product is to be used to assist in medical image review. Intended users are medical professionals, including imaging technicians, clinicians and surgeons.
Avatar Medical Vision includes three main software-based user interface components:
- the Splash Screen Interface (includes DICOM query),
- the Desktop Interface (includes 2D Interface, 3D Interface, and Autostereoscopic Interface),
- the VR Interface.
The Splash Screen Interface and Desktop Interface run on a compatible off-the-shelf (OTS) workstation provided by the hospital and only accessed by authorized personnel.
The Splash Screen Interface contains a graphical user interface where a user can retrieve DICOM-compatible medical images locally or from a Picture Archiving Communication System (PACS) or DICOM Server. Upon loading a DICOM series, the user is presented with the main Desktop Interface, which itself comprises a 2D and 3D Interface, with the option of switching to the VR and Autostereoscopic dedicated Interfaces. Users are able to make measurements, annotations, and apply fixed and manual image filters. Additionally, the Desktop Interface can be accessed through the Avatar Hub, a streaming service that allows users to securely access their remote computer where Avatar Medical Vision is installed.
The Autostereoscopic Interface is accessible via a compatible autostereoscopic display to allow users to review the medical images in a 3D autostereoscopic format. This interface is shown in the Desktop Interface. This 3D autostereoscopic format can be viewed only when the user connects a compatible autostereoscopic screen directly to the workstation being used to view the Desktop Interface. Avatar Medical Vision's autostereoscopic mode is compatible solely with the following autostereoscopic monitor:
- Barco Eonis 3D MDRC-8127
The VR Interface is accessible via a compatible OTS headset to allow users to review the medical images in a VR format. VR formats can be viewed only when the user connects a compatible VR headset directly to the workstation being used to view the Desktop Interface. Avatar Medical Vision's virtual reality (VR) mode is compatible solely with the following VR headsets:
- HTC Vive XR Elite
- Meta Quest 3
The 3D images generated using Avatar Medical Vision are intended to be used in relation to surgical procedures in which CT or MR images are used for preoperative planning and/or during intervention/surgery.
The intraoperative use of Avatar Medical Vision solely corresponds to the two following cases:
- Display of the Avatar Medical Vision Desktop Interface on existing standard (non-stereoscopic) monitors/screens in the operating room. The autostereoscopic screen is not intended for installation in the operating room to display Avatar Medical Vision.
- Use in a non-sterile image review room accessible from the operating room during the procedure (Avatar Medical Vision operates on VR headsets and on autostereoscopic screen, which are not approved to be used in the sterile environment of the operating room).
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