OsiriX MD

GUDID 07649990819006

The OsiriX MD software is an interactive image display and navigation program that was designed for medical imaging modalities. It supports all types of images generated by variety of imaging equipment and scanners available today. It supports the DICOM standard for image communication as well as a variety of other image formats used in academic and research community. OsiriX MD will act as a DICOM viewer capable of connecting to a DICOM network. OsiriX MD will be able to connect to various networked PACS, modalities and other DICOM nodes through the DICOM protocol over a TCP/IP network. OsiriX MD will provide manipulation tools for medical images. It also provides the necessary tools to query DICOM nodes, retrieve images from them and send images. OsiriX MD will also permit the efficient storage, and retrieval of medical images for imaging workstations. OsiriX MD is tailored for large sets of multidimensional and multi-modality images such as combined PET-CT studies that require three dimensional image fusion and volume rendering. The software is developed on MacOS platform. The software was developed in Objective-C in Apple Xcode development environment. In the design of the software a special attention was given to adapt the user interface to navigating through large sets of image data. The graphical user interface also uses the MacOS interface. Users can change and customize the software by adding and removing tools and items from the program toolbar and menu bars. This allows for adapting the software for number of functions and avoiding the users to be overwhelmed by an excessive number of unnecessary tools and functions that are not always needed.

Pixmeo Sàrl

Radiology picture archiving and communication system workstation

• Primary Device ID: 07649990819006
• NIH Device Record Key: 49b06ffc-3f21-47bc-8c09-c28340cf8e0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsiriX MD
• Version Model Number: 12.5.1
• Company DUNS: 485480318
• Company Name: Pixmeo Sàrl
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07649990819006 [Primary]

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-28
• Device Publish Date: 2022-02-19