Patient-specific, Maxillofacial Anatomical Model, For End-user Sterilization

Patient-specific, Maxillofacial Anatomical Model, Digital

Patient-specific, Maxillofacial Surgical Guide

Patient-specific, Orthopedic Anatomical Model, For End-user Sterilization

Patient-specific, Orthopedic Anatomical Model, Non-sterile

Patient-specific, Othopedic Anatomical Model, Digital

Patient-specific, Orthopedic Surgical Guide

InView automatically categorizes adult Transthoracic Echo (TTE) images by view/modality, reorganizes images according to relevant categorical attributes, and syncs all related views for current and prior studies.

ASCEND InView v9.5 is a software-only medical device intended for use by trained clinicians to display medical images. The ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types. ASCEND InView v9.5 is for use by prescription only. The 9.5 update is equivalent to the prior release in functionality with updates to the user experience and playback performance for a better experience to the end user.

The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.

DI DLS

FlexView Diagnostic is a stand-alone Web-based DICOM medical image viewer which allows downloading, reviewing, manipulating, and visualizing medical multi-modality image data in DICOM format and other data. FlexView Diagnostic is a server-based solution that may integrate with healthcare facility software systems and display DICOM images. FlexView Diagnostic enables healthcare professionals to access, manipulate, and measure DICOM images and collaborate using diagnostic quality medical images without installing client software. FlexView Diagnostic enables healthcare professionals to access, manipulate, and measure DICOM images and collaborate using diagnostic quality medical images without installing client software.

Analysis and reporting of vascular ultrasound images

Oasis is a SaMD (Software as a Medical Device). It is a software product designed to operate on an office PC. The product is intended for use by qualified medical personnel for the assessment of diagnostic medical images. The Oasis product is not intended to be used as a replacement for visual interpretation, nor as a diagnostic tool without the use of other clinical and laboratory information. The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of automatic and manual processing and displaying the medical image data in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. The Oasis system displays the processed images using an integrated computer. Oasis is a software-only medical device (a SaMD). Oasis does not directly or indirectly control any medical device that has contact with the user or patient. Oasis does not automate the diagnosis of a patient in any way. Oasis does not come into contact with patients and does not contain medicinal substances or non-viable animal/human tissues.

Vision Orthodontic Planning Device

Version 6.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement. Version 7.X.X: SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN), globus pallidus externa and interna (GPe and GPi, respectively) and the ventral intermediate nucleus (Vim) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement.

SpineAR Surgical Navigation Advanced Platform (SNAP) Operating Room System

iQ-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable brain structures from a set of brain MRI scans. It is intended to accelerate and improve the quantification of brain structures that would otherwise require a manual process of identifying, annotating, and measuring regions of interest in brain MRI scans. iQ-solutions™ consists of both cross-sectional and longitudinal analysis pipelines. • The cross-sectional pipeline is intended to conduct structure segmentation and volume analysis on brain MRI scans at a single time point.• The longitudinal pipeline is intended to conduct volume change analysis on a single patient’s MRI scans acquired on the same scanner, with consistent image acquisition protocol and with consistent contrast at two different time points. The results of the cross-sectional pipeline cannot be compared with the results of the longitudinal pipeline.

Simpleware Medical image processing.Applicable software versions (UDI-PI)00860011545705(8012)V-2024.0600860011545705(8012)W-2024.12

Condyle Position Guide - Ti

Final Orthognathic Surgical Splint

Final Orthog Surgical Splint Digital

Intermediate Orhognathic Surgical Splint

Interm Orthog Surgical Splint Digital

Palatal Orthognathic Surgical Splint - Resin

Palatal Orthog Surgical Splint Digital

Palatal Orthognathic Surgical Splint - TI

Guide anchor screws with dental support Ti

Genioplasty Surgical Guide - Resin

Genioplasty Surgical Guide with Splint - Resin

Genioplasty Surgical Guide with dental support - Ti

Genioplasty Surgical Guide - Ti

Le Fort Surgical Guide - Wall Resin

Le Fort Surgical Guide - Wall with Splints - Resin

Le Fort Surgical Guide - Slots Resin

Le Fort Surgical Guide - Slots with Splints - Resin

Le Fort Surgical Guide with dental support - TI

Le Fort Surgical Guide - Ti

BSSO Surgical Guide with Dental Support - TI

BSSO Surgical Guide - TI

Mandible Model

Mandible And Maxilla Model - 2 Piece

Complete Maxillofacial Model (fused)

Maxilla Model

Maxillomandibular Anatomic Diagnostic Model CL

Drill metal sleeve

Slot metal sleeve

Screw metal sleeve

The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system.