FDA.reportPublic FDA data

PIXMEO SARL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30125165363012516536PIXMEO SARL1N2026-01-01Pixmeo SARL 266 rue de Bernex Bernex Geneve CH 1233

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1912091539958018K101342OSIRIX MDLLZ2010-08-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ12010-08-20

PMN#

GUDID#

OsiriX MD - 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

2022-02-19