Philips Medical Systems GmbH, Dmc

Philips Medical Systems GmbH, Dmc specializes in diagnostic X-ray equipment. Their product lineup includes stationary X-ray tube housing assemblies, anti-scatter grids (used to reduce scattered radiation in imaging), stationary X-ray generators, digital fluoroscopic systems, stationary basic diagnostic X-ray systems, and computed radiography digital imaging scanners. These devices are designed for medical imaging applications where precise and high-quality X-ray visualization is required, such as in radiography and fluoroscopy.

Philips Medical Systems GmbH, Dmc operates through a U.S. subsidiary, meaning its U.S.-based devices are subject to FDA regulations. The company’s devices are listed in the FDA’s 510(k) and UDI registries, which are databases used to track medical devices that have undergone the necessary authorisation processes in the U.S. This reflects compliance with FDA requirements for medical device safety and performance before they can be marketed in the U.S. market.

Philips Medical Systems GmbH, Dmc’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) registry includes devices that have been cleared through the FDA’s premarket notification process, demonstrating substantial equivalence to a legally marketed predicate device. The UDI registry ensures each device has a unique identifier for tracking, improving patient safety and regulatory oversight by providing clear traceability throughout the device’s lifecycle.

The devices manufactured by Philips Medical Systems GmbH, Dmc fall under FDA classifications of Class I or Class II. Class I devices generally pose minimal potential risk and are subject to general controls, while Class II devices require additional performance standards to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, risk level, and the potential harm if it malfunctions, ensuring appropriate regulatory oversight.