Arcoma AB

Arcoma AB specializes in stationary basic diagnostic x-ray systems that use digital imaging technology. These devices are designed for medical facilities to perform high-resolution radiographic imaging, such as the OMNERA series (500A, 400A, 400T) and the INTUITION series (models 0170, 0180, and 0072 PRECISION). The focus is on stationary systems intended for fixed clinical environments.

Arcoma AB is based in the United States, which means its devices must comply with U.S. regulatory standards. Since the company’s products fall under the category of stationary digital x-ray systems, they are subject to FDA oversight. The U.S. regulatory framework determines classification, clearance pathways, and reporting requirements for these devices.

Arcoma AB’s devices are classified as FDA Class II under U.S. regulations. This classification requires premarket notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device, ensuring safety and effectiveness. Class II designation also means these devices undergo additional post-market surveillance and reporting requirements compared to Class I devices.

Yes, Arcoma AB’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identifier) registries. Inclusion in the 510(k) registry confirms that the device has undergone the required premarket review process to establish safety and performance. The UDI listing ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and manufacturers to track devices throughout their lifecycle.

The FDA’s Class II classification for Arcoma AB’s stationary digital x-ray systems indicates a moderate risk level. Unlike Class I devices (low risk), these require special controls beyond general controls to ensure safety and effectiveness. This includes mandatory 510(k) submissions, which assess whether the device is substantially equivalent to a predicate device with proven performance. The classification reflects the need for rigorous validation of imaging accuracy, radiation safety, and system reliability.