Philips Oy

Philips Oy specializes in MRI system-related devices, including software applications for radiotherapy planning and integration, such as RTgo and MR-RT. They also produce MRI phantoms and test objects, like geometric quality assurance phantoms and specialized anatomical models such as the MRCAT Head & Neck phantom. These devices support MRI system functionality and quality assurance in clinical settings.

Philips Oy is based in Finland, which means its devices fall under EU regulatory frameworks. The company’s products are classified under EU Class I and Class II, requiring compliance with EU medical device regulations. This classification determines the level of scrutiny and documentation required for market placement, such as registration in EUDAMED and adherence to essential requirements for safety and performance.

Philips Oy’s devices are listed in multiple regulatory databases to ensure transparency and traceability. Their products appear in EUDAMED, the European database for medical devices, as well as the FDA’s 510(k) premarket notification registry and FDA’s Unique Device Identifier (UDI) system in the U.S. These listings help regulators, healthcare providers, and patients verify device details and compliance status.

Philips Oy’s MRI system application software and phantoms are classified under EU Class I (generally low-risk devices) and Class II (moderate-risk devices). Classification depends on factors like intended use, risk of harm, and interaction with patients. Class II devices require additional scrutiny, such as clinical evaluations or conformity assessments, to ensure safety and performance before market placement.