INFINITT HEALTHCARE CO., LTD.

Infinitt Healthcare specializes in software and systems for healthcare imaging and radiation therapy. Their portfolio includes dental imaging software (like Xelis Dental 2.0), radiology picture archiving and communication systems (such as Infinitt PACS 7.0 and Infinitt RT PACS), radiation dose monitoring tools (e.g., INFINITT DoseM), and digital planning software for radiation therapy (e.g., INFINITT DPS). These products support diagnostic, archiving, and treatment planning workflows in clinical settings.

Infinitt Healthcare is headquartered in South Korea. Their devices are registered in the European Union through the EUDAQS/eudamed system and in the United States via the FDA’s 510(k) clearance pathway, demonstrating compliance with regional regulatory requirements for medical devices.

Infinitt Healthcare’s devices fall into different risk-based classifications: Class A and Class I (typically low-risk devices like software for imaging or archiving) and Class II (moderate-risk devices such as radiation dose monitoring or digital planning tools). Classification depends on factors like intended use, potential risks, and patient interaction, as defined by regulatory bodies like the FDA and EU MDR.

Infinitt Healthcare’s devices are listed in the EU’s eudamed database (via EUDAQS) and the FDA’s 510(k) registry in the United States. These registries track devices that have undergone the necessary regulatory processes for market authorization in those regions, ensuring transparency for healthcare providers and regulators.