Chimaera GmbH

Chimaera GmbH specializes in radiology picture archiving and communication system (PACS) workstations. These devices are designed to store, retrieve, and display medical imaging data in clinical settings, facilitating seamless integration and analysis of diagnostic images. The primary example products are the FUSIONSYNC and its variant, CHIMAERA FUSIONSYNC.

Chimaera GmbH is based in the United States. Its devices are authorised for use in the US market, where regulatory compliance is governed by the FDA. The company’s products are subject to FDA oversight, including classification and listing requirements.

Chimaera GmbH’s devices fall under FDA Class II regulatory classification. This classification applies to moderate-risk medical devices that require special controls to ensure safety and effectiveness. Class II devices typically undergo 510(k) clearance and must comply with the FDA’s Unique Device Identifier (UDI) system to ensure traceability and regulatory tracking.

Chimaera GmbH’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) database. These registries ensure transparency and compliance with US regulatory requirements, allowing healthcare providers and authorities to verify device authorisation status.