Gleamer Sas

Gleamer Sas specializes in developing radiological Picture Archiving and Communication Systems (PACS) software. Their primary focus is on tools that enhance medical imaging workflows, including specialized modules like BoneMetrics (US) for bone analysis and diagnostic aids such as BoneView and ChestView US for interpreting radiographic images. These products are designed to assist healthcare professionals in diagnostic assessments.

Gleamer Sas is based in the United States. Since the company operates within the US, its devices are subject to FDA regulatory oversight. The location also means compliance with US-specific requirements, such as the 510(k) premarket notification process and registration in the FDA’s Unique Device Identifier (UDI) database, which are critical for device authorization.

Gleamer Sas’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking. Additionally, their products are authorised through the FDA’s 510(k) premarket notification process, which is a key registry for Class II devices in the US. This process confirms that the devices meet applicable regulatory standards before entering the market.

Gleamer Sas’s devices fall under the FDA’s Class II regulatory category. This classification is based on the level of risk associated with the products—Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The company’s devices are authorised through the 510(k) pathway, which is standard for this classification.