Pixmeo Sàrl

Pixmeo Sàrl specializes in radiology picture archiving and communication system (PACS) workstations. Their primary offering is a software-based solution called OsiriX MD, which enables medical professionals to visualize, analyze, and manage DICOM medical images. This type of device supports diagnostic workflows in radiology settings by centralizing imaging data for review and interpretation.

Pixmeo Sàrl is headquartered in Switzerland. The company’s location in Switzerland may influence its regulatory compliance processes, particularly for European markets, as it aligns with EU medical device regulations.

Pixmeo Sàrl’s devices are listed in the EUDAMED database, which is the European Union’s transparency database for medical devices. Additionally, their products appear in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and identification in the United States. These listings help healthcare providers and regulators verify device details and compliance.

Pixmeo Sàrl’s devices fall under Class II and Class IIa classifications in the EU. Class IIa devices are considered moderate-risk, requiring additional scrutiny beyond general controls, while Class II devices involve higher risks and require more stringent design controls and post-market surveillance. The classification ensures appropriate regulatory oversight based on the device’s intended use and potential risks.